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

Dec 21, 2018

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.



What’s In Those Brownies Anyway? What You Need to Know About California Cannabis Edibles Regulations

Feb 14, 2018

With adult use of cannabis now legal in California as of January 1, 2018, some food companies may be considering adding “edibles” – cannabis-infused products that are intended for human consumption – to their product lines.  According to Forbes, edibles may account for more than half of the growth in the booming cannabis industry, as high-end food products infused with cannabis and cannabinoids are growing in demand for the discerning consumer who cares not only about the high, but also taste and quality.

But with legalization comes regulation, and the California Department of Public Health has issued emergency regulations detailing what is and isn’t allowed in manufacturing and selling edibles. Among the regulations are stringent requirements for THC content per serving and per package, and packaging and labeling requirements.

Here are some key things to know about manufacturing and selling edibles under the new California regulations.

Prohibited Products

There are certain things that you just can’t make into and sell as edibles.  Alcoholic beverages, dairy products, meat (other than dried meat) and seafood are out.  Products that have to be kept below 41° Fahrenheit to make them fit for human consumption are also out, as is juice that is not shelf-stable.  Products with additives such as nicotine or caffeine that would increase potency, toxicity or addictive potential, or that would create an unsafe combination with psychoactive substances, are prohibited.  But a product that has naturally-occurring caffeine, like tea, coffee or chocolate, is fine.  You can’t add cannabinoid concentrate or extract to commercially available candy or snack food with no further processing, and products that are easily confused with commercially available food products that do not normally contain cannabis are prohibited.

Don’t Make Them Appealing to Children

A big concern addressed by the regulations is preventing children from accidentally ingesting cannabis edibles.  To that end, manufacturers of cannabis edibles can’t make products that might be attractive to children.  Edibles that are shaped like a human, animal, insect or fruit are specifically prohibited.  If you are going to make cannabis gummies, for example, don’t make them look like gummy bears and don’t call them “candy.”    The terms “candy” or “candies” can’t be used.  The label and packaging can’t contain content that imitates candy packaging or labeling, or include anything that might appeal to children, such as cartoons or other images, characters, or phrases popularly used to advertise to children.  Finally, the packaging itself has to be child resistant and can’t look like packaging used for products typically marketed towards children.

THC Content and Servings

The regulations limit the amount of THC (tetrahydrocannabinol, the chemical compound in cannabis responsible for a euphoric high) that can be in edibles. Edibles may not contain more than 10 milligrams of THC per serving and 100 milligrams of THC per package.

Edibles have to be packaged so that a consumer can accurately identify a single serving.  Products that contain more than one serving have to be scored or delineated to indicate a single serving, if it is in solid form.  If it is not in solid form, it has to be packaged in such a way that a single serving is readily identifiable. For example, if selling a cannabis-infused drink, you may want to include a dosage cup similar to what comes with cough syrup. Each serving in a multi-serving package has to contain about the same amount of THC.

All product ingredients or components, other than the cannabis, cannabis concentrate, or terpenes, must be permitted by the U.S. Food and Drug Administration (FDA) for use in food or food manufacturing (Everything Added to Food in the United States).

Packaging Requirements

The packaging for edible cannabis products must:  (1) protect the product from contamination, (2) be tamper-evident, meaning that it is sealed so that it cannot be opened without obviously breaking the seal, (3) be child-resistant, (4) not imitate packaging for products typically marketed to children, (5) be opaque, and (6) if containing more than one serving, be re-sealable so that child resistance is maintained.

Labeling Requirements

If you are a food manufacturer, you know that making sure your labels are compliant with FDA regulations is important.  It is no different under the California regulations for edible cannabis products.  The labeling on packages of edibles must have two components:  a primary panel and an informational panel.

The primary panel must include:

  1. The identity of the product in a text size reasonably related to the most prominent printed matter on the panel, and the words “cannabis-infused” immediately above in a text size larger than the text size used for the identity of the product;
  2. The universal symbol as shown below, printed conspicuously and legibly, not less than a half inch by a half inch;
    CA Cannabis symbol
  3. Net weight or volume of the contents; and
  4. THC and CBD (Cannabidiol, the non-psychoactive cannabis compound) content of the package, as well as the THC and CBD content per serving, all expressed in milligrams.

The informational panel must include:

  1. Name and contact number or website address of the manufacturer;
  2. Date of manufacture and packaging;
  4. If for medicinal use, the statement “FOR MEDICAL USE ONLY”;
  5. A list of all product ingredients in descending order of predominance by weight or volume;
  6. If the product contains a major food allergen, the word “contains” followed by a list of such allergens;
  7. The names of any artificial food colorings contained in the product;
  8. The amount, in grams, of sodium, sugar, carbohydrates, and total fat per serving;
  9. Instructions for use, such as the method of consumption or application, and any preparation necessary prior to use;
  10. The product expiration date, “use by” date, or “best by” date, if any; and
  11. The UID (the unique identifier for use in the track-and-trace system established by the Department of Food and Agriculture) and, if used, the batch number.

The label can’t contain any claims that the cannabis was grown in a California county if it was not actually grown there and can only name the California county in which it was actually grown.  The label can’t have any false or misleading information, and can’t make any health-related claims that are untrue or misleading. However, the label can include a statement of effects – information on the characteristic anticipated effects if the manufacturer has substantiation that the information is truthful and not misleading, as long as there are no claims of health benefits.

Other Considerations

It’s important to note that cannabis is considered a controlled substance under the federal Controlled Substances Act, and despite legalization in California, trafficking in cannabis, including the manufacture and sale of  edible cannabis products, remains illegal under federal law.  Possible negative consequences, including federal criminal prosecution and tax liability, still exist. Along with the requirements outlined here, there are other requirements under California law with regard to obtaining a manufacturing license, testing, advertising, distribution and sales of edible cannabis products. It’s a brave new world of legalized cannabis in California, but before jumping in, it is important to first seek legal advice and to proceed with caution.