WHY THE FDA IS INSPECTING WINERIES

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 www.spiritedbiz.com. 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!

New Alcohol Delivery Oversight on the Horizon

By Rebecca Stamey-White and Jeremy Siegel

We’ve been hearing rumblings about possible legislation moving forward in Sacramento that will give the California Department of Alcoholic Beverage Control (“ABC”) more oversight over companies that deliver alcohol products here in California. Last week, we got our first look at Senate Bill 254, which had been a mere placeholder since its introduction on February 7 by Senator Portantino.  The proposed bill would add Business and Professions Code Section 25513 to the Tied-House Restrictions of the California ABC Act (as well as similar sections in the Code pertaining to tobacco, not covered by this blog post), which would for the first time define a “delivery network company,” and would prohibit companies that deliver alcoholic beverages (and/or tobacco products) from delivering these regulated products until receiving ABC approval of their delivery systems and abiding by certain requirements intended to curb access by minors. 

Under the bill, a “delivery network company,” defined as an “an organization… that provides prearranged delivery as an act of enrichment, financial or otherwise, of goods or services using an online-enabled application or platform to connect consumers with goods or service [sic] and to have those goods or services delivered directly to the consumer by an individual compensated by the organization,” would be required to submit its “system” to the ABC for review and approval.  That system must also include the following elements:

1. A means of verifying that the recipient of alcoholic beverages is 21 years of age or over;
2. Person-to-person delivery;
3. Delivery drivers that are 21 years of age or over;
4. The ability for consumers to suspend delivery for any period of time to their designated primary delivery location, and
5. No delivery to college or university grounds.

As currently drafted, the bill covers unlicensed service providers (Third Party Providers or “TTPs”) as well as current ABC licensees with privileges to sell alcohol directly to consumers that also provide delivery services to its customers.  We think it unlikely that the author’s intention was to include all retail deliveries of alcohol (a subject already covered by existing ABC regulations), but unless delivery network company is more narrowly defined, all licensees with off-sale retail privileges that currently deliver alcoholic beverages to consumers should be watching this bill.

While this is just the first draft of legislation that so far focuses on the ABC’s core constitutional priority of preventing sales to minors, a worthy and important goal, many questions regarding the regulation of delivery of alcohol still remain unanswered by this bill, including many we face in our daily practice:

1. What types of verification will be required and what kinds of records will the delivery network company need to collect? Signature capture, as required by UPS, Fedex and other shipping providers?  ID scanning?
2. What does person-to-person delivery mean? Is it a prohibition against deliveries without an adult present to receive the delivery or something else?  What needs to happen to the product or the transaction if no one is there to receive the order?  How must returns be handled?
3. What does it mean for the consumer to be able to suspend delivery to its primary delivery location and how does that advance the ABC’s interests in preventing sales to minors and encouraging responsible delivery of alcoholic beverages?
4. Will the ABC also want to see protocols for preventing sales to obviously intoxicated recipients?
5. Specifically as to TTPs, will the ABC also be reviewing flow of funds, percentage fees, tied-house implications and other hot button issues not covered by this legislation, or will they be restricted to reviewing only the portions of the system that prevent sales to minors?

Up until now, there have been no laws or regulations that specifically cover TPPs, which do not have an ABC license category.  The only substantive guidance for TPP businesses working with alcohol licensees has been ABC regulations concerning retail delivery and the industry advisories issued by the ABC in 2009 and 2011 (the “ABC Advisories”).  These ABC Advisories were originally issued to provide guidance for licensees seeking to leverage the consumer acquisition reach of the various internet and app sales and marketing platforms (Amazon, Groupon, LivingSocial, Lot18 and many others) that did not want to hold alcohol beverage licenses, but instead focused on advertising, customer acquisition, and online tools to facilitate sales and fulfillment of products or experiences including alcoholic beverages.  The ABC Advisories focused on the level of control and responsibility a licensee must maintain when utilizing a TPP as its agent, avoiding indirect unlawful gifts and retail inducements, flow of funds requirements, and avoiding engaging a TPP to conduct activities or taking margins that would otherwise require an independent alcohol license. 

While helpful guidance (for industry members, TPPs, alcohol lawyers and the many other states that have used the ABC Advisories as a model for their own TPP guidelines and laws), the ABC Advisories are not law, and the ABC has thus far declined to pre-approve TPP platforms, including the now ubiquitous delivery systems that are the subject of this bill and make up a large part of our firm’s TPP practice.  We’ve recently seen some uptick in ABC enforcement in this space that has provided some additional guidance on the ABC’s current stance on TPPs, but many TPPs have been operating in a legal gray area, dependent on legal memoranda from law firms focusing on alcohol beverage regulation like our own in order to ease investor concerns about legal compliance. 

We encourage any and all licensees and TPPs involved with alcohol delivery to get involved in the legislative process now to make their voices heard so that this bill can provide appropriate guidance to the ABC in the responsible and appropriate regulation of delivery network companies.  And if this bill becomes law, it’s a good time for businesses involved in this space to call your legal counsel to ensure you have the protocols in place to obtain the ABC’s approval.