We write this post with heavy hearts as wildfires continue to rage throughout Northern California, affecting many of our clients, friends and colleagues. The wildfire tragedy continues to cause the loss of homes, livelihoods and lives. We express deep love and gratitude to our devastated but resilient Northern California community and to the firefighters, law enforcement and first responders who are on the front lines.

As lawyers who serve the alcohol beverage, hospitality and cannabis industries, we offer a summary below of some of the regulatory considerations for industry members, and those who work within these industries especially hit hard by these fires. Unfortunately, our guidance for cannabis businesses will be even shorter, because of the unsettled legal landscape.

There’s no way around the fact that rebuilding after the wildfires pass will be difficult, expensive and time-consuming, but we know our community will come together to support each other during this difficult time.


The alcoholic beverage industry, which is regulated by a myriad of federal, state and local agencies, is subject to a plethora of special agency protocols that come into play when disasters strike. The major agency resources available to industry members at this critical time are summarized below, agency by agency.

Because every retail and production premises is licensed as a structure (with diagrammed premises, including bonds for producers), if a building has burned down or been destroyed, the premises may not still be suitable for operations. Where and how a licensee can continue operations pending rebuilding (or re-opening, if partial damage occurs) will be an issue for many wildfire victims. We expect the regulatory agencies will be cooperative and will do their best to waive otherwise inflexible requirements whenever possible.

Alcohol and Tobacco Tax and Trade Bureau (TTB)

Manufacturers, wholesalers, retailers, and export warehouse proprietors of alcoholic beverages who experience fire or other casualty losses may be eligible for tax relief from the TTB. Proprietors may make claims with the TTB for the payment of federal excise taxes paid on alcoholic beverages. The TTB is also waiving tax penalties for those affected by the fires.

TTB Resources:

California State Board of Equalization (BOE)

The BOE offers emergency tax and fee relief for business owners and feepayers. An extension of up to three months to file and pay taxes and fees is available for the alcoholic beverage tax and an array of other BOE administered programs (listed here).

BOE Resources:

California Department of Alcoholic Beverage Control (ABC)

The ABC requires licensees to conduct business on licensed premises, keep records available for inspection, and use their license (for example, wholesalers must make at least one sale to retailers every 45 days). But what happens if your business and records are damaged or destroyed and you can’t conduct business as usual? In the coming days, we anticipate the ABC will release fire-related guidance to assist licensees with the destruction caused by the wildfires. Until that time, licensees may find the ABC’s Napa earthquake-related information a useful resource, as it contains information related to the relocation of business operations, storage, breakage, returns, and tied house exceptions for natural disasters (here).

California Department of Insurance

For all insurance claims, contact your insurance company or your agent as soon as possible to gather information to file a claim. If partial damage has occurred, take steps to prevent further damage, take photos of the damaged property, and prepare an inventory of the damaged property. If the damage is extensive, you should not return to your homes and businesses until emergency personnel have cleared the area for reentry. If you haven’t been evacuated yet, but the threat still exists, take photos or take a video of your belongings and keep any receipts.

The California Department of Insurance Resources for Business and Homeowners:

United States Department of Agriculture (USDA)

The U.S. Department of Agriculture’s Risk Management Agency operates and manages the Federal Crop Insurance. If you have a Federal Crop Insurance policy—which only covers crops, not vines—claims may be made due to direct damage, smoke taint and potentially an inability to harvest.

USDA Resources:

U.S. Department of Food and Drug Administration (FDA)

All alcoholic beverage manufacturers should be registered with the FDA as a “food manufacturer” unless they qualify for a registration exemption. All registered manufacturers are subject to the FDA’s record-keeping and reporting requirements under the Bioterrorism Act and the newer Food Safety and Modernization Act. Anyone with production spoilages or losses (whether in production or finished product not yet distributed) should document these in detail by variety or brand name, vintage, volume of product lost or spoiled, and lot numbers, if available. Stay posted for specific reporting procedures for these losses for each category of alcoholic beverages once the emergency settles.

California Department of Food and Agriculture (CDFA)

The CDFA has extended the application deadline for the 2018 Specialty Crop Block Grant Program (here).


The fires are also devastating the cannabis industry. The timing is especially terrible since we are two and a half months away from the launch of state licensing. Our best suggestion for those still planning to seek state licensing after this tragedy is to protect the records and documentation required for temporary licensing, including business records, local jurisdiction authorizations or permits, and deeds or leases (information about temporary licenses available here). As local and state licensing is about to come online, many of the same concerns with regards to areas that may no longer be suitable for their intended and permitted use will apply to the cannabis space, as discussed above for alcohol licensees.

While there are unfortunately not the same types of government or insurance resources available as for the alcohol and hospitality industry (for example, cannabis cultivators and manufacturers do not qualify for crop insurance or federal emergency relief funds), the cannabis community is turning out to support those in need. Merry Jane has collected a number crowdfunding campaigns that have launched to support members of the industry impacted by the fires, including one organized by CalGrowers to help impacted farmers.

Looking for ways to donate, volunteer, or deliver supplies?

The Wine Institute has published a list (here) on how to help, including links to donate to local disaster relief funds. The Bay Area’s also has an extensive list detailing where you can make donations, deliver supplies, and which organizations are seeking volunteers (updated daily here). For the animal lovers among you, donations can be directed towards Jameson Animal Rescue Ranch here.

- The Team at Hinman & Carmichael LLP

Soon to come to your Local Supermarket– Instant Redeemable Coupons of the digital age!

New technology is difficult to use in the alcoholic beverage industry because old laws and regulations don’t accommodate new ideas. Today, however, we report a feel-good story.

Last year (2016) Governor Brown signed SB-1032, which prohibited wine supplier licensees from offering supplier-funded instant rebate coupons (“$1 Off at the register!”) at retail accounts. This brought wine suppliers into promotional equality with beer suppliers, who lost instant rebates in 2014.  Point of sale instant rebates, it was argued, benefitted large suppliers at the expense of smaller, craft producers.  Large retailer demand for IRC programs as a condition of carrying the product also worried the supplier tier.  Dueling IRC’s were increasingly becoming a very expensive competitive weapon.  The regulatory concern was that retailer redemption practices were prone to abuse because the redemptions went through the retailer.

This year, the California Legislature, recognizing that new technologies justify amendments to existing laws dealing with marketing promotions, added digital rebates to the list of permitted alcohol supplier marketing tools.  Digital rebates differ from instant rebates in several ways; the most important being that redemption is accomplished without running the money through retail accounts.

On October 2, 2017, Governor Brown approved AB-1722 and it is now law in California.  Business and Professions Code § 25600.3, which defines coupons and outlines what are permissible rebate practices, was amended to include “electronic or digital rebates” in the list of permitted alcohol supplier marketing tools.  The “iBotta bill,” as some call it, refers to one new mobile application that offers electronic digital rebates that can be redeemed during a sale without retailer involvement. We expect there will be more digital coupon vendors very soon.

AB-1722 also closed a promotional work-around in the earlier law that allowed beer and wine suppliers to continue to fund instant rebate coupons for non-alcohol products.*  New section 25600.3 now refines the definition of “coupon” to include a discount on the purchase of any item, whether it is an alcoholic beverage, or not.

Electronic digital rebates are a new and exciting tool for consumer engagement, and we expect more tools of this nature to come into existence as the technology to bring suppliers and consumers together at the point of sale develops. Think about the act of scanning a register receipt resulting in a consumers account being credited for a significant portion of the purchase price. Coupon clipping will be ancient history.

The new world of digital coupon clipping begins on January 1, 2018.


*We’ve received a few questions on whether this amendment impacts spirits suppliers, and their ability to offer cross-promotional instant rebate coupons for non-alcoholic products.  Spirits suppliers can breathe a sigh of relief, as their privileges remain unchanged after this refinement of the definition of “coupon.” Spirits suppliers are still permitted to offer “discount[s] or rebate[s] on the purchase of any item so long as no nonalcoholic beer, beer, malt beverages, or wine products are advertised or promoted by these licensees in connection with the discount or rebate.” Business and Professions Code Section 25600.3(c)(4)(B).

The License Piggyback Dilemma – If it Sounds Too Good to be True, it Probably is

However one happens upon the wine industry (love of wine, retirement from a lucrative profession into the countryside to grow premium wine grapes or just good luck), the subject of doing business in a regulated space becomes an issue sooner rather than later. Wine production and sales are subject to a dizzying mix of regulation at the federal and state level, enough to frighten even the most dedicated and well-funded. While regulation cannot be avoided, many people figure there must be an easier way to get started than by locating a facility and applying for the complicated licenses and permits.

Unfortunately, it’s not that simple. This blog post explores the dangers inherent in many of the common work-around solutions brought to us. Do these questions sound familiar?

“I don’t have licenses of my own, but can’t I just use a winery’s licenses to make my wine and get the products to market?”
“I sell a winery my grapes and they make the wine and sell it. Can’t I just have them use my name on the bottle, sell the wine and we split the profits?”
“I have my grapes custom crushed. Can’t I just use the winery’s DTC permits to service the 30 plus states in which I may not legally sell wine?”

These questions all refer to “license piggyback” scenarios, where one winery’s licenses are being used to incubate a new wine brand, or leverage markets foreclosed to non-licensees.

The Problematic Relationship

The problem with any “license piggyback” solution is the same problem facing third party provider (TPP) marketing websites: you cannot “avail” yourself of the privileges of someone else’s license. Specifically, licensees cannot share profits with non-licensees, and unlicensed persons and entities cannot take title to, or sell, alcoholic beverages without a license appropriate to the relationship. This has been ruled on by the California ABC and the New York SLA, and the principle is universal throughout the US alcohol regulatory system. Combine these restrictions with the proliferation of new brands from people using the marketing power of their famous names, and wineries who blithely provide services to their grape growing friends and neighbors for a cut of the profits, and it is easy to see how problematic relationships are born from well-intentioned business deals.

Custom Crush Arrangements

Brand owners are sometimes new to the alcohol beverage industry and its morass of legal restrictions, and do not realize that they need a license to sell wine. They sign standard custom crush agreements with wineries, which mandate somewhere in the fine print (too long; didn’t read) that the brand owner have the licenses to take title to the product. The winery doesn’t follow up, the brand owner cuts a check and moves product to a warehouse, then sells it either direct to consumers, or to a distributor and back into the three tier-system. If the winery allows its license to be used, it has made an unlawful sale and the brand owner has engaged in the purchase and sale of wine without a license. Those are criminal acts under the express terms of the California ABC Act. That is not good for peace of mind or (maybe, we could be wrong about this) running for political office.

Wineries should make sure that their custom crush clients have licenses to take title to the product wineries manufacture for them as part of the vetting process during contract negotiations (either that or they intend to drink the wine themselves, or give it away).

For brand owners, custom crush agreements are necessary if the plan is to obtain licenses to sell the wine at wholesale, or direct to consumers such as with the Type 17/20 license combination in California. If the goal is ultimately to become an alternating proprietor (AP) with a winery license, or an actual winery, we recommend this approach for brand incubation before committing to production equipment and the costs and complexities of an AP or a facility.

For the scenario where a custom crush 17/20 intends to take advantage of the winery’s DTC permits, the relationships between the parties must be carefully structured to operate within the confines of the law, with the winery retaining title to the wine shipped under its permits, and the 17/20 acting as a TPP. This requires a good, clear, contract. A good contract provides a mechanism to not only resolve disputes between the parties, it prevents an aggrieved party in a later dispute from claiming that the underlying relationship was unlawful and therefore the contract between the parties is unenforceable.

Full Service Route to Market Contracts

Sometimes, wineries themselves are not aware of the limitations on their own license privileges and their relationships with non-licensees. We have seen well intentioned wineries offer their clients a full suite of services, including winemaking, brand consulting and turn-key route to market strategies for a cut of the profits from wine sales.

The tricky aspect of these relationships is that ABC has not drawn a clear line distinguishing lawful arrangements from unlawful ones. Wineries can provide services to licensees and non-licensees alike, including brand strategy and consulting services. Wineries cannot perform services that amount to renting out their licenses, and they cannot share profits with non-licensees. Therefore, the extent to which these contracts are lawful is fact specific, and depends on what exactly the contract terms specify.

Licensing/Marketing Agreements

Another approach for brand owners is to never take title to the product, and instead sign Licensing/Marketing Agreements with wineries. These agreements (variations of the TPP relationship) license the brand owner’s intellectual property to the winery, and the brand owners receive compensation for providing marketing services to the winery to facilitate distribution of the products. The arrangements are a good choice for those who cannot hold supplier/wholesale tier licenses, or those who don’t want to bother. There are, however, limitations with this approach. Principally, the prohibition on profit sharing with non-licensees necessitates careful structuring of the compensation portion of the agreements between brand owners and wineries to ensure they don’t cross the regulatory line.


And now the $64,000 question, is this an enforcement priority for ABC? What is the potential liability? Regarding the former question, we are seeing California ABC investigate these relationships with increasing frequency, and we expect more inquiries into these relationships as ABC and the federal authorities understand the number of problematic relationships out there.

The potential liability question is more complicated. ABC has jurisdiction over licensed wineries, and actions against winery licensees have taken the form of fines and license suspensions (revocation is on the table for egregious or deliberate violators). ABC, however, does not have jurisdiction over non-licensees, and would have to engage another agency such as the Attorney’ General’s office to prosecute non-licensees for the sale of alcohol without a license (a criminal misdemeanor in California). This makes it harder for ABC to follow-up on non-licensees, but they could find an example as a warning to the industry. No one wants to be that example.

The other form of liability is contractual responsibility for the failed relationship; and damages. While who a court would find liable if a dispute occurs is a fact specific exercise, that one party was licensed and the other wasn’t would probably resolve for the unlicensed party on the theory that the licensee (as the one responsible for compliance) should have known better.

Another complicated question arises if the unlicensed entity becomes licensed, or is seeking licenses, when the ABC comes knocking. ABC’s Trade Enforcement Unit could hold up license issuance pending an investigation, could ultimately deny licensure based on the unlawful relationship and could file an accusation after the license issues to seek fines and penalties short of revocation.

Best Practices

As with most business endeavors, there is no one-size fits all approach regarding contract winemaking, AP agreements, TPP agreements or brand development. Every situation is unique, and requires a different structure to best utilize the strengths of each party to the venture. Each relationship must be considered carefully in the context of the parties’ goals to comply with the regulations applicable to licensees, and to the prohibitions against selling alcohol without a license.

That all being true, if the new wine industry member takes the time to analyze the goals it has against properly structured relationships, the process will be relatively painless (lawyers and regulators notwithstanding), and should be a lot fun.

A timely message from our Florida colleagues on the tied house laws, the three-tier system and the need for reform

 One of our close friends in Florida, Marbet Lewis of Greenspan Marder, recently penned an article about the need for reform of the tied-house laws in Florida. Marbet focused on the craft brewing industry and the difficulty of the small producer to develop its business in a time of overall consumer desire to experience authentic small brands.  She was speaking about craft distillers and craft brewers in Florida, but she could just as well be speaking about small wine, beer and spirits producers in California, Texas, Illinois, New York and throughout the US. 

While the industry benefits from the basic framework and ideology of tied house laws, our modern economy demands more targeted exemptions and special classifications to both promote and regulate growth – Marbet Lewis.

Marbet’s thesis is that our world of outdated tied house laws interferes with the healthy inter-tier relationships that benefit consumers and the industry; this includes access to investment capital and (especially in craft distilling) direct and effective access to customers via marketing channels and direct to consumer permits.  Her call for targeted “exemptions” as versus the system of special interest exemptions should resonate with all forward-thinking industry members.

 Enjoy Marbet’s fine article here.

ABC Declaratory Rulings – A Modest Proposal Whose Time has Come

By John Hinman and John Edwards

The Problem – New Technology and Process Innovation

Today’s alcoholic beverage industry is marked by technological and process innovation at every level, and in ways that were unfathomable even a decade ago. Information retrieval, accounting systems, ordering and delivery systems, social media and other new technologies pose challenges for regulators around the country attempting to fit new initiatives into statutes and regulations enacted in an earlier era. 

The regulatory challenge usually involves determining what the controlling statute or regulation means in the context of the business facts presented. The problem with quick conclusions is that facts are often not presented clearly or in an orderly fashion, which results in difficulty for both the agency and the business attempting to discern if the new business falls within the permitted activity portions of the ABC Act. 

What a statute or regulation means in the context of approving or prohibiting creative industry programs is always a challenge – new technologies usually do not neatly fit into the narrow legislative and regulatory enactments crafted for a different time. 

That results in a system where approval of new and innovative business concepts, often ones that are permitted by other states or the federal government, are routinely denied, or are undertaken under a cloud, which impacts regulators, investors, managers and licensees.

Many regulators take the position that whatever process or innovation is sought cannot be permitted unless the legislature has expressly permitted it. However, sponsoring legislation is an expensive and time consuming process and new legislative exceptions often create more problems than they solve. 

The Solution – Create a Forum for Program Analysis; NY does it and so can California

We propose a solution where the burden is on the new technology or system developer to prove to the ABC that the system is legal, and to provide an efficient forum for presenting that case.

This was brought home in a recent (January 19, 2017) declaratory ruling by the New York State Liquor Authority approving the Instacart internet marketing platform and product delivery protocols in New York.  The importance of the ruling to Instacart and those using similar marketing platforms and delivery protocols cannot be overstated.

Significant investment of time and money in a marketplace can only be justified by industry member (and service provider) confidence that what they are doing will not threaten the licenses of the participants in the system or, worse yet, expose the participants to criminal charges for violating the state alcoholic beverage laws (for example, all violations of the California ABC Act are statutory criminal misdemeanors, and that could conceivably include liability for aiding and abetting the offense).

New York is one of many states that have a specific alcoholic beverage declaratory ruling procedure.  California, however, has no specific procedure for obtaining rulings on alcoholic beverage business proposals.  The lack of such a procedure hobbles innovation and introduces unjustifiable and unnecessary risk into the process of investing in, and managing, California businesses.  Given the importance of the industry to the State, California’s regulation of alcohol can and should be made more transparent and should provide guidance on which industry members can rely.

Creating a Declaratory Rulings Protocol – it can be done

California has an administrative ruling statute that provides for declaratory rulings (through an agency not used by the ABC). We propose that the authorizing statute be amended to specifically include the ABC, to provide for ABC Appeals Board review of the ABC’s action in accordance with the California Constitution, and to provide for designating rulings as “precedent.”

Here is our proposed language. Please note that the Section 1 exclusion of the ABC from the general Government Code section is what allows the Section 2 inclusion of the ABC into the new procedure that we propose.  That’s how the Government Code works.

Section 1

Government Code Section 11465.10 is hereby amended as follows:

Subject to the limitations in this article, an agency, other than the Department of Alcoholic Beverage Control, may conduct an adjudicative proceeding under the declaratory decision procedure provided in Sections 11465.10 to 11465.70 of this article.

Section 2

The following sections are added to Article 14 of the Government Code:

Section 11465.80

(a) Any person may file a Petition with the Department of Alcoholic Beverage Control for a declaratory decision with respect to the applicability to any person, property, or state of facts of any statute or rule enforceable by the Department.

(b) Petitions for a declaratory ruling by the Department shall:

(i) Contain a statement of the declaratory ruling requested;

(ii) Include a concise statement of the state of facts or uncertainty with respect to which a declaratory ruling is required and may include a statement by the petitioner of the outcome sought and the reasons therefor; and

(iii) be filed with the Department and directed to the attention of its General Counsel.

(c) The Department of Alcoholic Beverage Control shall reject any Petition for a declaratory decision as to which any of the following applies:

(i) The Petition does not comply with requirements of subsection (b) of this section;

(ii) The decision would substantially and directly prejudice the rights of a person who would be a necessary party and who does not consent in writing to the determination of the matter by a declaratory decision proceeding;

(iii) the Petition presents a matter that is the subject of pending administrative or judicial proceedings.

(d) Unless the Department of Alcoholic Beverage Control rejects a Petition pursuant to subsection (c), the Department shall:

(a) Publish the Petition on its website; and

(b) Provide a period of not less than 30 days for interested parties to file comments with respect to the relief requested and a period of not less than 10 days for the petitioner to file responses to the comments of interested parties; and

(e) The Department of Alcoholic Beverage control may, in its discretion, schedule a public hearing on the issues presented by any Petition for a declaratory decision, at which it may permit the introduction of evidence.

(f) The Department shall issue a ruling on the Petition in writing within not less than 80 days after the date of the filing of the Petition.

(g) The Department shall designate each of its rulings on Petitions for a declaratory decision as Precedent and index all such precedents, including any subsequent rulings thereon by the Alcoholic Beverage Control Appeals Board or any court, as precedent pursuant to Government Code Section 11425.60.  The index and all rulings on Petitions for a declaratory ruling shall be published on the Department’s website.

Section 11465.90

The ruling issued by the Department shall constitute a “decision” within the meaning of Bus. & Prof. Code Section 23080.  The Petitioner or any person who filed comments with the Department may appeal the ruling to the Alcoholic Beverage Control Appeals Board pursuant to Bus. & Prof. Code Sections 23080 to 23089.

The Key Concept – Create a body of decisional law - Precedent

The most important word in this proposal is “precedent.” 

Precedents in the purest sense are examples of how the statutes and regulations are applied in actual cases. As precedents are developed they create a body of law that can be relied upon by legal practitioners, industry members and trade associations alike.  This removes uncertainly and provides an avenue for a reasoned consideration of new and innovative proposals against a background of established examples that can be used to guide conduct. 

Please note that under our proposal a petition could not be filed with the ABC after a violation has already occurred and an accusation or other proceeding initiated.  That, as well as assuring that the ABC retains essential discretion to approve or disapprove proposals, assures the integrity of the ABC’s accusation process, and insures that the ABC's other powers are not compromised.

The ultimate result will be a body of published decisions that every industry member and service provider can rely upon in making important investment and business decisions, and a mechanism for seeking illumination in those situations where the answers are unclear.  That would enable continued innovation and provide the kind of certainty that one of the most important industries in California deserves.

It’s a win-win.

More on FDA Inspections - Breweries, Distilleries and Questions

BY:  Barbara Snider, Erin Kelleher and John Hinman

We received some great comments and questions regarding the recent (May 22, 2017) blog “Why the FDA is Inspecting Wineries.”

One of the most common questions was “does the FDA inspect breweries and distilleries?  The answer is a resounding yes. If you are a brewery or a distillery, revisit the original post for more detail.

Breweries and Distilleries.

The bottom line is that the rules are the same for all alcoholic beverages.  Most breweries and distilleries, like wineries, sell their products through general commerce and therefore, must register with the FDA and follow the same Good Manufacturing Practices.  All domestic companies must register unless they are considered a “retail food establishment” or “qualified facility” and are exempted from registering as described below in more detail.

Breweries and distilleries, like wineries, are also exempt from Subpart C (Hazard Analysis and Risk-based Preventative Controls) and Subpart G (Supply-Chain Program) but like wineries, must comply with Subparts A and B (related to sanitary conditions and training of employees in personal hygiene) and Subpart F (recordkeeping).

Breweries and distilleries are also subject to FDA inspections and the best practice is to be aware and prepared.  Therefore, the advice and brief checklists provided in the May 22nd blog apply equally to them. 

The one difference for breweries and distilleries is the disposal of spent grains from the manufacturing process.  In 2014 the FDA caused much consternation with its proposed rule that would require breweries and distilleries wishing to send the spent grain for animal feed to additionally comply with the hazard and risk analyses and a supply chain program under the Animal Food regulations.  (This would be in addition to complying with the human food regulations with which all alcoholic manufacturers must comply). 

The good news is that the FDA listened to the outcry against adding this additional regulatory burden and the current rule provides that processors already implementing human food safety requirements do not need to implement additional preventive controls when simply supplying a by-product (wet spent grains) for animal feed.  Breweries and distilleries are expected to assure that there is no physical contamination of the spent grain before shipping.  For example, contamination by placing trash or cleaning chemicals into the container holding the spent grain.  General sanitary conditions apply to transporting the spent grains for animal feed.

It is important to note, however, that any processor who further “processes” the spent grain for use as animal food (for example, drying, pelleting, heat-treatment) must additionally comply with the Animal Food Good Manufacturing Practices which include developing hazard and risk-analyses and developing preventative controls. 

The brewery or distillery may choose which path to take.

How does the FDA exemption for “Retail Food Establishments” apply to wineries, breweries and distilleries?  

We had many questions about how the exemption (which is not exactly a model of clarity) works.  The exemption as it applies to producers (such as wineries in the initial post but also including breweries and distilleries in this post) is very narrow.

The FDA exemption from the registration requirement is for producers that can demonstrate its primary purpose is to sell product directly to the consumer and that sells more than 51% of their product “out the front door” (“Retail Food Establishments”).  So, the question is whether a producer’s business operations are such that it meets the definition of “Retail Food Establishment.” 

First, even though the initial blog was written for wineries, because all alcoholic beverages are “food,” those breweries or distilleries that may qualify as a “retail food establishment” could possibly also fall under this narrow exception. 

As part of the implementation of the Food Safety Modernization Act (“FSMA”), the FDA amended and expanded the definition of “Retail Food Establishment”.  The official definition of a “retail food establishment” in the Code of Federal Regulations is:

“Retail food establishment means an establishment that sells food products directly to consumers as its primary function. The term “retail food establishment” includes facilities that manufacture, process, pack, or hold food if the establishment's primary function is to sell from that establishment food, including food that it manufactures, processes, packs, or holds, directly to consumers. A retail food establishment's primary function is to sell food directly to consumers if the annual monetary value of sales of food products directly to consumers exceeds the annual monetary value of sales of food products to all other buyers. The term “consumers” does not include businesses. A “retail food establishment” includes grocery stores, convenience stores, and vending machine locations.  A “retail food establishment” also includes certain farm-operated businesses selling food directly to consumers as their primary function.” (Highlighting and emphasis added.)

Therefore, any winery, brewery, distillery that can qualify as a “retail food establishment” demonstrating that its primary purpose is to sell its product directly to consumers will be exempted from the FDA registration requirement. 

This means that the annual monetary value of sales of food products directly to consumers must exceed the annual monetary value of sales of food products to all other buyers (at least 51% direct to consumer sales).  The term “consumers” does not include businesses unless (as discussed below) you operate within in a small local area in the same state (truly local businesses) and can be characterized a “Qualified Facility.” 

The FDA determined that all “direct-to-consumer sales” (DTC) including Internet and mail order sales are included as part of the calculation to determine whether the primary purpose is to sell directly to consumers.  The FDA stated that there is no requirement that DTC must be a face-to-face sale.  Therefore, sales proceeds from Internet and mail catalog DTC sales may be used in the calculation to determine that the primary function is to sell directly to consumers.  Sales made at farmers’ markets, consumer events, directly from tasting rooms and the like are also considered in the calculation. 

Further, while the earlier blog discussed the size requirement needed to qualify as a “retail food establishment” (less than 11 employees) in adopting the final rule, the FDA did away with any employee size requirement to qualify for the retail food establishment exemption stating:  “Even if some establishments that use mail, catalog, and Internet orders in determining their primary function are larger establishments and can reach consumers on a national level, we do not believe that is inconsistent with section 102(c) of FSMA, which does not specify that FDA’s amendment to the retail food establishment definition only pertains to establishments of a specific size.”  

The principal criteria the FDA will use in determining if an establishment qualifies as a “retail food establishment” is whether its primary purpose is to sell its product direct-to-consumer. The FDA’s basic test is whether an establishment’s annual monetary value of sales of food products directly to consumers exceeds the annual monetary value of sales of food products directly to all other buyers, i.e., more than 51% of its sales are direct-to-consumer.

This appears to be another benefit of the alcoholic beverage industry move to DTC (practically and legislatively) where possible. 

“Qualified Facilities”.

We did receive a comment asking us to explain what “Qualified Facilities” means.  This very narrow exemption from the FDA registration requirement applies only to very small businesses that principally operate locally.  Very briefly, a “qualified facility” status applies to those facilities that sell product to consumers, restaurants or “retail food establishments” located in the same state and not located further than 275 miles from the qualified facility.  There are also monetary limits on the value of product sold during the prior 3-year period (less than $500,000 adjusted for inflation).  Attestations and documentation are required.  Should anyone desire more information on this, please call the FDA, your trade association representative, or your attorney.

Recall Procedures.

We received some inquiries asking whether a winery (or brewery/distillery) needs to develop a “Recall Plan” in the case there is need for the recall of the product.  The first point to make is that the TTB has primary control over any recalls for alcoholic beverages and does not require a company under its jurisdiction to prepare a Recall Plan.  While it might be a good idea and a good business practice to have a plan of action regarding what to do if you need to recall a product from the market, know that it is not required by the TTB and the FDA cannot impose that requirement (at least not yet!). 

You should feel comfortable if the FDA inspector asks about your recall plan and you don’t have one (although we do encourage adoption of a recall plan as a basic best practice). 

Conclusion – Be Compliant!

We encourage our clients and friends to approach FDA compliance in the same orderly way that they approach all compliance topics.  There should be an officer or manager of the facility charged with the principal responsibility of compliance with operating regulations – whether labor and employee related, production facility related (use permits and equipment safety under OSHA for example), alcohol production and sales related (ABC, TTB and local state OSS permits) or food product related (FDA and local food service requirements for example). 

The smaller the enterprise of course the more the burden falls on fewer people.  That is also why we encourage checklists and spending quality time with your industry trade associations, who have a vested interest in making sure that their members know the rules.

This is a complex issue with many moving parts.  We encourage you to contact your trade association representative or your attorney with your questions before you get that call informing you that the FDA inspector is on the way.


By Barbara Snider* and Erin Kelleher

The FDA is on the march and busy auditing food processors under their jurisdiction. While this leads to angst for the business caught up in the FDA bureaucracy, it is a fact of life for those who handle food and beverages, which are substances that are ingested by the public. No one argues against food and beverage safety and it’s one of the reasons we have the most respected alcoholic beverage industry in the world.  Our products are safe and the world knows it. The FDA is one reason why.

The purpose of this post is to give some comfort to those who are FDA compliant (or are small enough to be outside of the ambit of the FDA’s inspection power but who comply anyway) and to give some guidance to those who may have missed the message until now.

At the end of the post are important checklists. We urge you to pay close attention to the acronyms, and to the guidelines. There will be a test, but hopefully not one that starts with a knock on the winery’s door.

Federal Law, Wineries and the Very Narrow Small Winery Exemption

Under Federal law, wineries are “food manufacturing plants.”  As a food manufacturing plant, every winery must:

(1) Be registered with the FDA under the Bioterrorism Act (BTA),

(2) Re-register every two years, and

(3) Keep records of every source of food received (for example, grapes) and the destination of food (in this case, wine) shipped. 

Wineries with fewer than 11 employees and that sell more than 50% of their product out the front door (direct to consumer is how we interpret this) are exempted from this regulation.

Because the fermentation process kills pathogens and wine is low pH, wineries are categorized to be “low risk” food manufacturing facilities.  Thus, inspections of wineries have been a low priority for the FDA.  Most wineries have never even had an FDA inspection. 

That is now changing because of the FSMA.

The FSMA Priorities

The Food Safety Modernization Act (“FSMA”) was signed into law in January 2011, and made sweeping changes to food safety laws.  The FSMA focus changed food safety regulations from responding to food contamination to preventing food contamination.  Under the new FSMA law, even all “low risk” facilities (such as wineries) must be inspected within seven years of the Act becoming law, which means the FDA has now stepped up winery inspections for 2017. 

The Good Manufacturing Practices (“GMP”) and the Sub-parts Applicable to Wineries

The FSMA also updated the Good Manufacturing Practices (“GMP”) regulations. The FDA notes that wineries are exempted from Subpart C (Hazard Analysis and Risk-based Preventative Controls) and Subpart G (Supply-Chain Program) both of which require a written and documented food safety plan at the facility.  Wineries, however, must specifically comply with Subpart B (education and training of employees in food hygiene and safety) and Subpart F (record-keeping).

FDA Inspections – No Prior Notice Required and What to Prepare for

The FDA is not required to, and generally does not give prior notification of an inspection.  The FDA also partners with state agencies to help get the inspections done; so, for example, in California, the inspection could be made by the California Department of Food and Agriculture (“CDFA”) on the FDA’s behalf.  Other states also have counterpart agencies with the same functions as the CDFA. There can be no doubt that the FDA has geared up for inspecting the wineries, thus, wineries should be prepared. 

The best way for a winery to prepare is to do an internal inspection now, ahead of time, on all compliance requirements.  Here is our suggested checklist:

1.  The winery should designate one or two persons who can be available on-site during an inspection without prior notice. 

2.  The winery should be sure all necessary documents are up-to-date and readily available.  This includes the Bioterrorism reporting on food ingredients received and used in each wine shipped by the winery (see BTA checklist below). Copies of approved COLAs should also be readily available.

3.  Wineries should be aware that one important change under the FSMA for wineries is that education and training in food hygiene and safety is now required for all employees.  The winery must maintain records of the training for two years.  Each employee must be trained as necessary to conduct the winery processes.

4.  It is best to have a written flow chart of the winery processes demonstrating sanitation in the stages of winemaking.  The flow chart should also include monitoring with adequate frequency.

5.  One area of concern raised by the FDA inspections has been outdoor receiving of product, washing and fermentation tanks.  Wineries should document efforts to assure these processes and the area are kept as sanitary as possible (the FDA has specifically raised concerns regarding birds, dogs, cats in the area which could contaminate the grapes/juice).

6. Everything in the winery should be clearly labeled, even sanitizer spray bottles, etc. 

7. The FDA is particularly concerned that bottling rooms/areas be kept clean and sanitized to avoid contamination during bottling.

8. The Code of Federal Regulations (21 CFR 110.35) sets forth very specific sanitation issues with which wineries should be sure to comply.  Briefly, the only toxic materials that may be used or stored in a plant where food is processed or exposed include:

(a)    Those required to maintain clean and sanitary conditions;

(b)   Those necessary for use in laboratory testing procedures;

(c)    Those necessary for plant and equipment maintenance and operation;

(d)   Those necessary for use in the plant’s operations.

(e)   Toxic cleaning compounds, sanitizing agents, and pesticide chemicals must be identified, held, and stored in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials.

(f)    Pest control, and pets. No pests shall be allowed in any area of a food plant. Effective measures must be taken to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests. The use of insecticides or rodenticides is permitted only under precautions and restrictions that will protect against the contamination of food, food-contact surfaces, and food-packaging materials.  With respect to Pets, the CFR states that guard or guide dogs may be allowed in some areas of a plant if the presence of the dogs is unlikely to result in contamination of food, food-contact surfaces, or food-packaging materials.

9. Make sure sufficient water, hot water and water pressure is available for sanitizing and that all drainage and sewage facilities are in working order.

10. The FDA also requires adequate toilet and hand-washing facilities be available for employees with proper signage requiring hand-washing.

Remember the Bio-terrorism Report requirement?  We have a checklist for that also

For immediate previous food sources (yeast, fining, eggs, etc.), the report must include:

●  Name of the firm providing the food source

●  Name of responsible individual

●  Address

●  Telephone number

●  Fax number and e-mail address, if available

●  Type of food, including brand name and specific variety

●  Date received

●  Lot number or other identifier if available

●  Quantity and type and size of packaging (e.g., 750 ml bottles)

●  Name of carrier that brought the item to you

●  Carrier's address

●  Carrier's telephone number

●  If available, carrier's fax number and e-mail address

The winery must also keep track of each ingredient used in each wine that is produced, bottled and shipped by the winery.

The FDA has not prescribed specific penalties, but simply reminds food facility operators and importers that non-compliance with registration, prior notice, or recordkeeping requirements (once they are mandatory) are prohibited acts, and violators are subject to civil or criminal court action. Foods imported from non-registered facilities or without proper prior notice are subject to being detained at the port of entry.

Conclusion: Preventative Maintenance Works

If your eyes aren’t fatigued by reading these checklists, then you haven’t been paying attention! Because these regulations apply to almost all wineries, being prepared is much better than being audited, found wanting, perhaps fined and faced with the possibility of future audits.


*As a former winery owner (and a skilled Hinman & Carmichael LLP attorney), Barbara Snider approaches FDA matters from experience, a realistic compliance perspective, and a thorough appreciation for best practices.

Senate Bill 378—The Proposed Demise of Due Process for Alcohol Licensees

By: John Edwards & John Hinman

This blog post concerns a very significant piece of legislation (Senate Bill 378) currently being considered by the California Legislature.  For over 60 years, licensees have had the right to challenge ABC license suspensions before they go into effect; SB 378 takes away that right. SB 378 removes existing and basic due process rights of all types of alcohol beverage licensees to challenge potentially arbitrary and capricious ABC action in a neutral forum – actions that are often undertaken at the behest of local authorities or neighbors with an axe to grind against the licensee involved.

The tension between local authorities, neighbors and licensed establishments has never been higher and can be seen in licensing and enforcement decisions involving wineries, distilleries, breweries, retail stores and nightclubs throughout the state.  If the basic rules of engagement in place since the 1955 adoption of the ABC Act are going to be significantly changed then at the very least the licensees of this state should be adequately informed of the reasons for basically doing away with the Appeals Board by stripping away the Board’s power to do pre-penalty review.

Historical Background: the ABC Act and the Appeals Board

The ABC Act was adopted in 1955 to create a clear interface between the power of the state to regulate alcohol and the rights of California alcohol licensees to operate their businesses free of discriminatory, arbitrary and unfair enforcement.  This followed a period where establishments (particularly gay bars in San Francisco in the infamous 1950’s era “Black Cat” cases) had been singled out by law enforcement for special undercover State Board of Equalization (then the alcohol licensing and enforcement authority) investigations aimed at wiping out the perceived “immorality” that had started to blossom in the San Francisco entertainment community, and in other places throughout the state.

The history of alcohol enforcement up until that time had been marked by the indiscriminate, and often arbitrary, use of the state police power to punish those whose activities were deemed “immoral,” a phrase that covered a lot of activities, including personal sexual preferences. The result after reform was Article XX, Section 22 of the California State Constitution. This article created an independent agency (the Department of Alcoholic Beverage Control or “ABC”), which itself was to be checked by an oversight board called the “Alcoholic Beverage Control Appeals Board,” which was made up of three members appointed by the Governor, who serve at the Governor’s pleasure. The purpose of the Appeals Board was to establish limited review as a matter of right of ABC decisions in cases assessing punishment where the decision was alleged to be unlawful, unfair, arbitrary or capricious. The following constitutional standard now applies to Appeals Board review:

Review by the board of a decision of the department shall be limited to the questions whether the department has proceeded without or in excess of its jurisdiction, whether the department has proceeded in the manner required by law, whether the decision is supported by the findings, and whether the findings are supported by substantial evidence in the light of the whole record. In appeals where the board finds that there is relevant evidence which, in the exercise of reasonable diligence, could not have been produced or which was improperly excluded at the hearing before the department it may enter an order remanding the matter to the department for reconsideration in the light of such evidence. In all other appeals the board shall enter an order either affirming or reversing the decision of the department.” Article XX, Section 22, California Constitution.

This articulation of the ABC Appeals Board review power is as basic a description of “due process” rights as one can imagine. Who can argue with requiring findings, or substantial evidence, or prohibiting punishment based on evidence improperly excluded? Without this level of available review the ABC could proceed in an arbitrary and capricious manner, could punish licensees based upon the whim of whoever was in power at the time or, even worse, based on false allegations from disgruntled local neighbors and authorities.  Testing allegations of misconduct before punishment is imposed in a fairly conducted judicial hearing is a fundamental right.

The system has worked well for the last 60+ years, but not without occasional tension between the ABC and the Appeals Board. Even though the ABC probably prevails in 95%+ of the appeals that are filed, the ABC still does not like being overruled by the Appeals Board. In recent years, the ABC has made clear on many occasions its displeasure with Appeals Board decisions requiring that the ABC observe basic legal rights (including its own regulations). In fact, as explained below, the ABC currently takes the position that the Appeals Board decisions cannot be relied upon by licensees seeking guidance as to what is and is not lawful in an increasingly complex world.  That itself is a serious issue.

What Does Senate Bill 378 Do?

This brings us to State Senator Anthony Portantino’s Senate Bill 378. This bill threatens the livelihoods and due process rights of alcoholic beverage licensees throughout California.  Senate Bill 378:

●      Empowers the ABC to issue “temporary” restraining orders suspending licenses;

●      Provides that the “temporary” restraining orders can last up to 22 days (or even longer) before a hearing is held by the Department (which itself has just issued the order) on whether to expand that order to a preliminary injunction, which, in turn, would last until a hearing on the merits, which is scheduled at the discretion of the ABC (which in our experience, usually takes three to four months to calendar);

●      Strips the Appeals Board of its constitutionally-created power to review “temporary” restraining orders of the ABC and, instead, relegates licensees to petitioning a Court of Appeal to issue a discretionary writ of review;

●      Allows “temporary” restraining orders to be issued at the behest of the Department or a city attorney; and

●      Allows the ABC to issue the “temporary” restraining order on the strength of an affidavit signed under oath by a police chief, county sheriff or mayor/city manager.

What Could Go Wrong?

The bill would make possible the following scenario:  A city official reacts to a local resident who complains about an establishment by filing an affidavit accusing the licensee of violating the ABC laws.  The Department issues a “temporary” restraining order suspending the license, and the first opportunity that the license may challenge that order does not occur for 22 days, during which its business is shut down.  The Department can then issue a preliminary injunction continuing the shut-down until a hearing on the merits, which will be scheduled at the Department’s discretion—could be a month, could be a year.  Even if the charges are ultimately proven to be false at the hearing on the merits, few licensed businesses are likely to survive the prolonged shut-down.  A licensee’s only avenue of redress is to seek review from a Court of Appeal, which may or may not grant the petition, and certainly not until the damage from the shut-down has already happened.

Good luck to the investors in that business.

Even aside from the substantial question of whether Senate Bill 378 violates the California Constitution, it would make dangerous and unnecessary changes to California law for the following reasons:

1.      The ABC already has the power to act quickly to forestall violations by filing accusations and scheduling prompt hearings.  There is no need to empower it unilaterally to issue suspension orders on the say-so of city officials operating in a political arena.  There are many cases on the books in which the Appeals Board or the courts have rejected the allegations of complaining local officials after they had been tested under oath in a contested hearing, or discovered a lack of evidence to prove a local resident or ex-employee’s allegation. 

2.      As noted above, the Appeals Board has a constitutionally-created role of appellate jurisdiction over actions of the Department.  The drafters of the California Constitution wisely decided that some direct oversight of the enormous discretion vested in the ABC was necessary.  That judgment has been vindicated by many years of practice.  The advantages of Appeals Board review are that appeals can be taken as a right, the process takes far less time than a typical appeal to the busy Courts of Appeal and the members of the Appeals Board are well-versed in industry practice and ABC law.

The Courts of Appeal are already busy and often reject appeals from the ABC Appeals Board as it is.  Senate Bill 378 would require licensees whose licenses have been suspended by a “temporary” order to seek review in a Court of Appeal, with the Court having the discretion to grant or deny such review.  The Courts of Appeal have general appellate jurisdiction over all civil and criminal appeals, and their dockets are crowded. 

How likely are the Courts to put aside appeals from murder convictions and multi-million dollar civil cases to give expedited treatment to the “temporary” suspension of an ABC license, even though the consequences to the licensee’s livelihood may be devastating?  To ask that question is to answer it.

What, Then, Is the Motivation Behind This Bill? 

SB 378 appears to be a continuation of the ABC’s ongoing effort to free itself from appellate oversight by the Appeals Board.  Last year, the ABC took the position that decisions of the Appeals Board are not “precedent” and that referring to prior decisions is illegal and unethical.  The Appeals Board rejected that fatuous argument in a lengthy opinion, noting that:

[T]he only potential beneficiary in a world where prior decisions of the Board must be ignored and the Department has issued no precedential decisions itself, is the Department….  ‘If no one can cite or rely upon decisions of the Board, the Department is free to disregard them and create its own “shadow world” of unrestrained discretion—precisely what the Legislature sought to eliminate’….[1]

Senate Bill 378 appears to be yet another attempt by the ABC to achieve unrestrained and effectively unreviewable discretion.  This attempt is as unmeritorious and dangerous as the prior one.

How significant is this? As the first section of the ABC Act provides:

Section 23001 . . . It is hereby declared that the subject matter of this division involves in the highest degree the economic, social, and moral well-being and the safety of the State and of all its people. All provisions of this division shall be liberally construed for the accomplishment of these purposes.

You can’t get much more important than that.

Licensees should not have their livelihoods put at risk on the unchallenged say-so of municipal officials usually operating based on local political beefs, without any means of redress for at least 22 days and, more likely, much longer, and without any guarantee of the timely appellate review that has been a hallmark of ABC practice for many years.  Senate Bill 378 would put the entire alcoholic beverage industry at the mercy of municipal officials, angry neighbors and the unrestrained discretion of the ABC.  Licensees and their trade associations should make every effort to ensure that it does not become law. 

What Can You Do about This? 

Call or write State Senator Anthony Portantino and share your view on the merits (or lack thereof) of SB 378 and then call your trade association leaders and let them know your views.  Here’s a likely incomplete list of some of the alcohol industry trade groups we have supported in the past to get you started.

[1] BMGV, LLC v. Dept. of Alcoholic Bev. Control (Appeals Board 11/17/16) AB-9568, p. 25.  The ABC, represented by the Attorney General, has petitioned for a writ of review of portions of the Appeals Board’s decision, excluding the portion addressing the issue of the Board’s prior decisions as precedent.

ABC Enforcement - Trends and Predictions

What wineries should know about beverage law, rules and investigations

By: John Hinman, Rebecca Stamey-White and Jeremy Siegel

As long time supporters of Wine Business Monthly, we are always more than happy to contribute when given the opportunity.  Wine Business Monthly is the wine industry’s leading publication for wineries and vineyards, and they asked us to provide their readers with an overview of the California Department of Alcohol Beverage Control’s current enforcement trends, and what we see in the near future. 

The article, which can be found in the April issue of the magazine, touches on some of the bigger cases we have defended over the past few years, the lessons learned from these cases, and areas where we have been able to effectively negotiate with the ABC to not only avoid costly hearings for our clients but to further their marketing and sales agendas through legally compliant programs.  These areas include social media marketing and advertising, indirect ownership and other interests between retailers and suppliers, as well as the important details and restrictions that flow from events such as winemaker’s dinners.  Looking forward toward this year’s ABC enforcement priorities, we also commented on a recent uptick in ABC enforcement with regards to credit laws, we touched on the growing prominence of unlicensed third parties in the wine space and we noted that the ABC’s trade enforcement unit is enlarging and becoming more active.  You may never know when that knowledgeable new consumer at your event is really an ABC Agent testing compliance. 

We hope that this article highlights the value of understanding the laws and policies that govern activities in our highly regulated space, as well as the value of consulting effective and experienced alcohol counsel when in doubt.  Grappling with the alcohol laws is not for the faint of heart, but with strong compliance programs, direct confrontations with the ABC (in California and throughout the US) should be few and far between. 

The Corruption Chronicles – Volume One: A New Hope

A new publication has emerged on the industry scene, and it promises to be one of the most useful resources we have seen in a long time – Spirited Magazine (the website for the new magazine is There is another site for an old publication called spirited magazine.  Don’t confuse the two). Spirited crosses beverage types (wine, beer, spirits, cider and mead), looks at issues common to all licensed producers, wholesalers and retailers of all beverages and tries to make sense of it all.  We now live in a world where the large and small winery, brewery and distiller are all competing, and are all facing the same marketing and regulatory challenges. 

Many of our clients in each space are involved with other alcoholic beverage products and, as a result, are now experiencing first-hand the fundamentally inconsistent regulatory treatment of the different products.  Something legal for wine is unlawful for beer, something legal for spirits is unlawful for wine, and so forth.  It creates a very frustrating dynamic not only for the industry member but for the regulator who, let’s face it, has a very difficult job.  To add to the chaos, every state is a regulatory island unto itself.  That means national and regional marketing and other programs have to be carefully vetted against multiple different laws and regulations, and narrowly tailored to comply with the strictest.

The challenge with cross-involvement is that while most of the regulatory rules of the road (including licensing, distribution, marketing, event privileges and consumer sale privileges) are different for each beverage type, the penalties for violation of the historic “tied-house” laws, which apply to all beverage types, are almost identical and are often draconian.  We talked to the Spirited Magazine founders about this and the response from us will be the “Corruption Chronicles” – a series of tales of actual violations (and the lessons to be learned from each) published on an occasional basis in Spirited, and republished on Booze Rules for the edification of our friends and colleagues.

Volume One can be found here. Volume Two will be in the next edition of Spirited.

The point of the Chronicles is to illustrate the types of actual violations that regulators in California and around the country are pursuing. Bribery of retail accounts, smuggling of alcohol from one jurisdiction to another to evade taxes, suppliers managing retail account liquor departments and choosing what products the retailer will buy and in the process shutting out their competition; these are all examples of corrupt activities that impact the marketplace, threaten fair competition and justify vigorous regulatory responses.

But, and this is the big BUT, where is the line between clean competition and corrupt activity? When does an innocent act or agreement cross the line?  Is intent required (sometimes yes, sometimes no). Does the “everyone else is doing it” defense ever work? Those are the questions the Corruption Chronicles will explore.  Welcome to the world of Hinman & Carmichael LLP!