How many times has any parent heard the familiar lament, “Everybody else is doing it!”  Usually, that feeble protest is met with a definitive response along the lines of “That doesn’t make it right.”  And, usually, that’s the best answer – especially when it comes to CBD.

Anyone who attended this year’s Natural Products Expo West in Anaheim, California or Expo East in Baltimore, Maryland knows that CBD products seemed to be just about everywhere.  Some exhibitors even claimed that their products were “fully compliant.”  That is an interesting assertion given that the FDA has expressly stated that CBD cannot be used as an ingredient in foods or dietary supplements.  With regard to food, any substance that is intended to be a component of a food is a food additive, making it subject to premarket approval by the FDA unless it is already generally recognized as safe (GRAS) among experts qualified by scientific training and experience to evaluate its safety under the conditions of its intended use.  CBD does not enjoy GRAS status.  Similarly, the FDA has concluded that CBD products are excluded from the dietary supplement definition under the Food, Drug & Cosmetic Act (Act) because CBD is an active ingredient in an existing drug, Epidiolex, a prescription medication intended to treat seizures.

While certain states may have looser views as to whether CBD can be used in those products, they do not trump the Act or the FDA.  In other words, nothing is actually prohibiting the FDA from taking enforcement actions against manufacturers or distributors of CBD-containing food and dietary supplement products.

But, wait!  What about major retailers’ recent announcements that they would be carrying “topical” products in various states across the country?  This product category includes creams, sprays, roll-ons, lotions, salves and soap.  That doesn’t sound like a drug, food or dietary supplement.  “Topicals” sounds like … uh … cosmetics!  That must be okay, right?  Well, let’s take a look at the overarching Act to see if that conclusion holds up.

The Act defines “cosmetics” as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body … for cleansing, beautifying, promoting attractiveness, or altering the appearance….”  Act, sec. 201(i).  Products generally deemed to be cosmetics include skin moisturizers, perfumes, lipsticks, shampoos, deodorants, and so on.  On the surface, this seems to be the general category that “topicals” fall into.  However, whether a product is a cosmetic or a drug under the law is determined by a product’s intended use.

The Act defines drugs, in part, by their intended use, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease,” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals….” Act, sec. 201(g)(1).  Products such as prescription medicines or flu vaccines, for example, are clear examples of drugs.

Wait, what?  Some products meet the definitions of both cosmetics and drugs?  Yes.  This happens when a product has more than one intended use.

So, how is a product’s intended use determined?  As with most straightforward questions, the legal answer is “it depends.”  The intended use can be indicated by the claims stated on the product labeling, in advertising, on the Internet, or in other marketing materials.  The intended use can also be establishing by consumer perception of what it is used for and/or the product’s marketplace reputation.  Additionally, if a product has a well-known therapeutic use, that can establish it as a drug (e.g., fluoride toothpaste).

An example provided by the FDA on its website to illustrate this point would be that of a shampoo.  It is a cosmetic because it is intended to clean hair, but if it is also formulated to treat dandruff, it would also be considered a drug.

“Okay, but so what?” you are probably asking.  Manufacturers just need to be careful about identifying their CBD products’ intended uses.  Not so fast.

If a manufacturer is not careful about the claims made on its product’s label and associated labeling (such as a website), what the manufacturer intends its products to be used for might not hold up.  Under the Act, drugs must generally either receive premarket approval by the FDA through a New Drug Application (NDA) process or conform to a monograph for a particular drug category.  These monographs specify  the conditions under which over-the-counter drug ingredients are generally recognized as safe and effective.  CBD does not currently enjoy this classification.

“Well, what about the Farm Bill?” you ask.  An overly broad reading of that legislation has not been endorsed by the FDA when it comes to CBD.  In a December 2018 statement following the passage of the Farm Bill, the FDA expressly noted:

In particular, we continue to be concerned at the number of drug claims being made about products not approved by the FDA that claim to contain CBD or other cannabis-derived compounds. Among other things, the FDA requires a cannabis product (hemp-derived or otherwise) that is marketed with a claim of therapeutic benefit, or with any other disease claim, to be approved by the FDA for its intended use before it may be introduced into interstate commerce. This is the same standard to which we hold any product marketed as a drug for human or animal use. Cannabis and cannabis-derived products claiming in their marketing and promotional materials that they’re intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases (such as cancer, Alzheimer’s disease, psychiatric disorders and diabetes) are considered new drugs or new animal drugs and must go through the FDA drug approval process for human or animal use before they are marketed in the U.S. Selling unapproved products with unsubstantiated therapeutic claims is not only a violation of the law, but also can put patients at risk, as these products have not been proven to be safe or effective. This deceptive marketing of unproven treatments raises significant public health concerns, as it may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.

And, we should talk about soap.  The regulatory definition of “soap” is different from the way in which people commonly use the word.  The regulated term “soap” only applies when:

• the bulk of the non-volatile matter in the product consists of an alkali salt of fatty acids and the product’s detergent properties are due to the alkali-fatty acid compounds, and
• the product is labeled, sold, and represented solely as soap.  (21 CFR 701.20).

“Soap” products that meet this definition are regulated by the Consumer Product Safety Commission (CPSC).  If a product intended to cleanse the human body does not meet all the criteria for soap, it is considered to be a cosmetic (and, if you are not careful, it might also be a drug).  Which puts us back in line with the regulatory chutes and ladders process that I outline above.

The takeaway?  While a major retailer may be willing to push the issue in an effort to meet consumer demand, it is important to remember that retailers have no law or rule making authority.  Whether the FDA takes more concerted action to stop or otherwise question the sale of CBD products at retail stores remains to be seen.  However, what cannot be reasonably disputed is that many of those products are not likely in compliance with the Act or FDA guidance at this time.  Therefore, just because everyone else seems to be diving in head first, doesn’t mean that you should be.

“Krümel Monster Muffins” by Xitu is licensed under CC BY-SA 4.0

The regulatory status of a food ingredient is governed by certain bright line rules.  Any substance that is reasonably expected to become a component of food is a food additive.  A food additive is subject to premarket approval by the Food & Drug Administration (FDA) unless the substance is generally recognized as safe (GRAS) among experts qualified by scientific training and experience to evaluate its safety under the conditions of its intended use, or it otherwise satisfies some other exclusion from the food additive definition in section 201(s) of the Federal Food, Drug, and Cosmetic Act (Act). Any food additive that is intended to have a technical effect in the food is deemed unsafe unless it either conforms to the terms of a regulation prescribing its use or to an exemption for investigational use.  Any food that contains an unsafe food additive is adulterated under section 402(a)(2)(C) of the Act.

However, when it comes to CBD, this regulatory framework gets lost in the minds of many businesses looking to gain a toehold in the marketplace.  In December, I wrote a word of caution regarding the passage of the Farm Bill and its meaning (or lack thereof) for CBD in food and dietary supplements.  The intervening months since the Farm Bill’s passage have proven to be interesting.  Confusion, whether caused by ignorance of the applicable laws and regulations or denial about the limitations of those controlling rules, seems to be the norm when it comes to CBD in food and dietary supplements. 

Whenever I tell an interested manufacturer or distributor that CBD is not an authorized ingredient in either category, I routinely hear familiar protests: “Well, how come I see other products proudly marketing CBD as an ingredient?  What about the Farm Bill – what if the CBD is from hemp?”  The short answer, of course, is that while the FDA has been facing calls to update its regulations in light of the Farm Bill, CBD is still not authorized by any federal law or regulation to be used in food or dietary supplements, which then informs state law and regulations, which are largely modeled on the Act.  The longer answer, though, is because cannabis study has been greatly controlled and stymied by the federal government, because regulators may not understand CBD and how it can be derived, and because the FDA has not begun to meaningfully crack down on CBD products apart from a few Warning Letters pertaining to unsubstantiated CBD claims, policing the market place has fallen upon individual states.  The absence of consistent policing efforts to date, in turn, may give the impression that CBD use in food and dietary supplements is acceptable.   That should not be the takeaway.  As policing efforts are picking up steam, a quick rundown of what is happening in a few nationally influential states might be helpful in clearing up what seems to be so commonly misunderstood:  CBD is not an authorized additive or ingredient in food and dietary supplements.

California

While a liberal state in many regards, California is following the FDA’s lead.  California Health & Safety Code Section 109935 defines “food.”  Excluded from that definition are products containing cannabis.  Thus, as a threshold step, California is not classifying edibles as food; rather, such products can only be sold at licensed cannabis dispensaries.

Additionally, the California Department of Public Health has squarely addressed whether industrial hemp-derived CBD can be used in food or dietary supplements:

California incorporates federal law regarding food additives, dietary use products, food labeling, and good manufacturing practices for food . . . . Currently, the United States Food and Drug Administration (FDA) has concluded that it is a prohibited act to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which tetrahydrocannabinol (THC) or CBD has been added. This is regardless of the source of the CBD – derived from industrial hemp or cannabis.  Therefore, although California currently allows the manufacturing and sales of cannabis products (including edibles), the use of industrial hemp as the source of CBD to be added to food products is prohibited. Until the FDA rules that industrial hemp-derived CBD oil and CBD products can be used as a food or California makes a determination that they are safe to use for human and animal consumption, CBD products are not an approved food, food ingredient, food additive, or dietary supplement.

New York

New York City regulators just took a bite out of the Big Apple’s CBD restaurateurs.  The New York Times recently reported that the Department of Health and Mental Hygiene confiscated one bakery’s CBD-infused goods, raw ingredients and CBD powder, and it has ordered all restaurants under its jurisdiction not to sell any food products containing CBD.  Although the bakery claimed that there was “a general lack of clarity” around the use of CBD in food, ignorance of the law is what really seems to have resulted in that uncertainty on the part of the bakery.  The regulators, on the other hand, seem clear eyed.

Texas

No, no, no.  Well, maybe.  That’s pretty much sums up Texas, which is considering legislation that would establish regulations regarding hemp cultivation.  Even so, Texas (like California) is following the FDA’s lead and it does not allow CBD in any food, dietary supplement or cosmetic.

Colorado

But – wait!  What about Colorado?!  Well, it is true that the Colorado Department of Public Health & Environment does allow use “of all parts of the industrial hemp plant” as a food ingredient “in Colorado.”  However, Colorado is not saying that CBD, in general, can be used as a food additive, nor is it suggesting that its policy is consistent with federal or other state law, and its permissive attitude regarding industrial hemp comes with strict conditions. 

In order for food to contain industrial hemp, a manufacturer must be able to demonstrate the following:

• All parts of the hemp plant utilized in food must come from a state that has an established and approved industrial hemp program or a country that inspects or regulates hemp under a food safety program or equivalent criteria to ensure safety for human consumption.

• The producer/grower must be in good standing and compliance with the governing laws within the state or country of origin.

• The industrial hemp must conform to the standard of identity established in C.R.S., §35-61-101(7) of no more than three-tenths of one percent delta-9 tetrahydrocannabinol (THC).

• The use of other parts of the hemp plant other than seed and its derivatives (seed meal, flour, and oil), must be lab tested to establish that THC levels are not above the allowable limit of THC.

• The product must be labeled in conformance with state and federal labeling laws, including:
  • clearly identify hemp as an ingredient;
  • clearly identify CBD and the amount of CBD if added as an isolate;
  • include the statement “FDA has not evaluated this product for safety or efficacy” and;
  • not contain any health or benefit claims.

• The producer must be able to document that the finished product does not contain more than three-tenths of one percent THC.

Colorado’s conditions are thoughtful, particularly as they relate to testing and identification, but they do nothing to insulate a manufacturer or distributor from the policies of other states.  What goes in Colorado does not mean that it will be accepted in other jurisdictions. Indeed, police in Idaho and Oklahoma have started seizing products being transported across state lines that they deem to be cannabis over the protests of the transporters who claim that the products are actually hemp and, thus, protected from such seizure.  But, that is a story for another post…

Given this brief overview of what some states are doing, I hope that everyone will please keep in mind that the Wild West-approach is better suited for movies.  No manufacturer, distributor or retailer should act with impunity or out of ignorance to the legal restrictions surrounding CBD and its use in food or dietary supplements.  While there are many people and organizations working to enact sensible policies, we just are not there yet. Until we are, we need to work within the law in an effort to cultivate the legitimacy necessary for the cannabis industry to thrive and grow.

“Krümel Monster Muffins” by Xitu is licensed under CC BY-SA 4.0

Wendel Rosen attorney Bill Acevedo, who co-chairs the firm’s Food & Beverage Practice Group, posted a new blog at FoodLaw.com addressing the “confusion” in the marketplace regarding the use of CBD as an additive or ingredient in food and dietary supplements. 

Bill provides an overview of the way four nationally influential states are handling the issue due to the lack of direct enforcement by the FDA of its unequivocal regulatory prohibition of CBD use in food or dietary supplements.

You can read the full post here:

“C” is for “Confusion” When It Comes to CBD

Followers of Wendel Rosen’s California Cannabis Law Blog may be aware that our firm hosts another blog focusing on food and beverage law at FoodLaw.com. Today, Wendel Rosen attorney Bill Acevedo, who co-chairs the firm’s Food & Beverage Practice Group, posted a new blog explaining the truth behind the new so-called Farm Bill.

Many in the cannabis industry were hoping to hang their hats on the Agriculture Improvement Act of 2018 (aka, the Farm Bill) and its anticipated relaxation of the controls on the production and marketing of hemp as an implicit sign that it is acceptable to use cannabidiol (CBD) in food and/or dietary supplements. Bill explains how the Food and Drug Administration’s guidance dashes those hopes.

You can read the full post here:

Proceed at Your Own Risk: The Farm Bill Does Not Authorize CBD in Food or Dietary Supplements

I have said it before, and I will say it again: no, you cannot use CBD as an ingredient in food or dietary supplements. While some have touted the recent passage of the Agriculture Improvement Act of 2018 (aka, the Farm Bill) and its relaxation of the controls on the production and marketing of hemp as an implicit sign that it is acceptable to use cannabidiol (CBD) in food and/or dietary supplements, those fortune tellers are wrong. Yesterday, the Food & Drug Administration released an updated guidance document regarding its current positions on cannabis and CBD, in particular.

The FDA has expressly stated that THC and CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the Food, Drug & Cosmetic Act (the Act). If a substance such as THC or CBD is an active ingredient in a product that has been approved as a drug or that has been authorized for investigation as a new drug, then products containing such substances are outside the definition of a dietary supplement. According to the FDA, “[t]here is an exception to sections 201(ff)(3)(B)(i) and (ii) if the substance was ‘marketed as’ a dietary supplement or as a conventional food before the drug was approved or before the new drug investigations were authorized, as applicable. However, based on available evidence, FDA has concluded that this is not the case for THC or CBD.”

With regard to food, the FDA has also provided unequivocal guidance:

Under section 301(ll) of the FD&C Act, it is prohibited to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which has been added a substance which is an active ingredient in a drug product that has been approved under 21 U.S.C. § 355 (section 505 of the Act) or a drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public.

While there are exceptions to this rule when the drug has been previously marketed as a food before the drug was approved or clinical investigations involving the drug was initiated, like dietary supplements, the FDA has concluded that none of these exceptions apply for THC or CBD.  Accordingly, the FDA has concluded that “it is a prohibited act to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which THC or CBD has been added.”

Given this clear guidance, I stand by my often provided advice to clients (and to those of you reading this blog):  CBD cannot be used in food or dietary supplements, and if you do so, you proceed at your own risk. The Farm Bill does not serve as any legal basis for the use of CBD-derived hemp. In fact, the Farm Bill expressly preserved the FDA’s current authority to regulate products containing cannabis or cannabis-derived compounds. Until the FDA approves the use of CBD, I would also caution against any rationalizing of the use of CBD that comes from hemp as opposed to cannabis. As the FDA notes, it has seen no evidence to change its current thinking on CBD, but it will consider any evidence to the contrary by interested parties. Thus, if you want to use CBD, do your homework, develop your evidence, and then work with your legal counsel to present your findings to the FDA so as to obtain approval of including CBD in your product before you release it in commerce.