FDA is aware that there is a lot of interest in the development and marketing of FDA based products. It is also aware that many companies are violating the Food, Drug, and Cosmetic Act (FD&C Act) by marketing products that haven’t been approved as new drugs, making improper dietary supplement claims, using false labeling, and violating other FDA regulations. In an attempt to respond to the do’s and don’ts of FDA regulations, as CBD is continually examined, the FDA has a list of FAQs online. Many of the questions and answers we’ve discussed in our prior articles:
Some of the questions and answers from their most recent 2019 summary follow:
- What are cannabis and marijuana?
- How does the 2018 Farm Bill define “hemp?” What does it mean for FDA-regulated products?
- Has FDA approved any medical products containing cannabis or cannabis-derived compounds such as CBD?
- What is FDA’s reaction to states that are allowing cannabis to be sold for medical uses without the FDA’s approval?
- Has the agency received any adverse event reports associated with cannabis use for medical conditions?
This article focuses on current drug and medical uses, CBD products as dietary supplements or foods, and the legality issues involved with selling CBD-based products. A second Q and A will be posted soon.
Aside from Epidiolex, are there other CBD drug products that are FDA-approved? What about the products I’ve seen in stores or online?
No, not as of this blog post’s publication. The FDA has not approved other drug products from CBD. Instead, it has issued several warning letters to companies that are marketing that the their CBD products are able to treat diseases and have other therapeutic uses. The FD&C Act categorizes a product as a drug if is “intended to have a therapeutic or medical use, and any product (other than a food) that is intended to affect the structure or function of the body of humans or animals.
Avoid these common FDA mistakes marketing health products: communicating with FDA without legal counsel, making disease claims, misunderstanding the rules.
- Either have premarket approval – through the FDA’s New Drug Application (NDA) process or
- Conform to a “monograph” for a particular drug category, as established by FDA’s Over-the-Counter (OTC) Drug Review.
Drugs that are not approved – cannot be sold or distributed through interstate commerce. Firms should consult with experienced FDA lawyers about the distribution and sale of CBD products – within a state. Generally, online marketing, by itself, will indicate that the product is being sold across state lines.
Companies that sell unapproved drugs through interstate commerce:
- Violate the law
- Put patients at risk – since products that are deemed unsafe “raise significant public health concerns, because patients and other consumers may be influenced not to use approved therapies to treat serious and even fatal diseases.
- Are a danger, according to the FDA, because they have not been evaluated as to:
- Whether they work,
- What the proper dosage may be if they do work
- How they could interact with other drugs
- Whether they have dangerous side effects or other safety concerns.
While the FDA will continue to monitor the distribution and sale of FDA products, it does also appreciate the potential therapeutic opportunities that cannabis or cannabis-derived compounds could offer and acknowledges the significant interest in these possibilities. Currently, the FDA believes the “new drug approval process” is the best way to serve patients in need while protecting the public from harm.
However, expect more changes in FDA regulation of CBD products. FDA states:
“The Center for Drug Evaluation and Research (CDER) is committed to supporting the development of new drugs, including cannabis and cannabis-derived drugs, through the investigational new drug (IND) and drug approval process.”
Why hasn’t FDA approved more products containing cannabis or cannabis-derived compounds for medical uses?
The FDA is concerned that that CBD is being touted as a treatment for all types of health problems such as “AIDS wasting, epilepsy, neuropathic pain, spasticity associated with multiple sclerosis, and cancer and chemotherapy-induced nausea.” The agency’s duty, as set forth in the FD&C Act, is to rely on applicants and scientific investigators to “review data submitted to the FDA in an application for approval to ensure that the drug product meets the statutory standards for approval.” The review generally requires clinical trials to determine how safe and effective these CBD products are.
“The FDA’s December 2016 Guidance for Industry: Botanical Drug Development provides specific recommendations on submitting INDs for botanical drug products, such as those derived from cannabis, in support of future marketing applications for these products. The FDA will continue to facilitate the work of companies interested in appropriately bringing safe, effective, and quality products to market, including scientifically-based research concerning the medicinal uses of cannabis. Additional information concerning research on the medical use of cannabis is available from the National Institutes of Health, particularly the National Cancer Institute (NCI) and National Institute on Drug Abuse (NIDA).”
Can THC or CBD products be sold as dietary supplements?
No. Based on available evidence, FDA has concluded that THC and CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act [21 U.S.C. § 321(ff)(3)(B)].
Under that provision:
- “If a substance (such as THC or CBD) is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act [21 U.S.C. § 355]”
- “Or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public”
Then products containing that substance are excluded from the definition of a dietary supplement.
The “FDA considers a substance to be “authorized for investigation as a new drug” if it is the subject of an Investigational New Drug application (IND) that has gone into effect.”
“Under FDA’s regulations (21 CFR 312.2), unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the FD&C Act.”
“There is an exception to section 201(ff)(3)(B) 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.”
“Numerous other legal requirements apply to dietary supplement products, including requirements relating to Current Good Manufacturing Practices (CGMPs) and labeling. Information about these requirements, and about FDA requirements across all product areas, can be found on FDA’s website.”
What is FDA’s position on cannabis and cannabis-derived ingredients in cosmetics?
The general answer is that the FDA seems to indicate is that CBD ingredients can be used in cosmetics:
- Unless the CBD ingredient causes the cosmetic product to become adulterated – if it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling, or under such conditions of use as are customary or usual (section 601(a) of the FD&C Act [21 U.S.C. § 361(a)]).
- Unless the product is misbranded.
- Unless the product is a drug or a combination of a cosmetic and a drug – If a product is intended to affect the structure or function of the body, or to diagnose, cure, mitigate, treat or prevent disease, it is a drug, or possibly both a cosmetic and a drug, even if it affects the appearance.
Legal Definition of a Cosmetic
A cosmetic is defined in 201(i) of the FD&C Act – as:
“(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and
(2) articles intended for use as a component of any such articles; except that such term shall not include soap.”
“Under the FD&C Act, cosmetic products and ingredients are not subject to premarket approval by FDA, except for most color additives. Certain cosmetic ingredients are prohibited or restricted by regulation, but currently that is not the case for any cannabis or cannabis-derived ingredients. Ingredients not specifically addressed by regulation must nonetheless comply with all applicable requirements, and no ingredient – including a cannabis or cannabis-derived ingredient – can be used in a cosmetic if it causes the product to be adulterated or misbranded in any way.”
The FDA can take action if it has information that an ingredient or cosmetic product is unsafe to consumers.
Is it legal for me to sell CBD products?
The answer is – it depends. The FDA will look at:
- The intended use of the product
- How the product is labeled
- How the product is marketed
It’s generally not enough that the CBD product meets the 2018 Farm Bill definition of hemp. The product must still comply with the FD&C Act. The FDA states that it is working with state and local authorities to discuss and answer questions about the federal law and the current state laws and regulatory issues.
Will FDA take action against cannabis or cannabis-related products that are in violation of the FD&C Act?
“The FDA has sent warning letters in the past to companies illegally selling CBD products that claimed to prevent, diagnose, treat, or cure serious diseases, such as cancer. Some of these products were in further violation of the FD&C Act because they were marketed as dietary supplements or because they involved the addition of CBD to food.”
FDA warning letters generally require that the firm or individual in receipt of the letter consult with an experienced FDA compliance lawyer. The attorney will advise you on the current law, whether you can challenge the FDA findings, or whether you need to create a compliance plan. If a compliance plan is required, they’ll advise you on what steps you should consider.
If there is no adequate reply to a warning letter, the FDA will consider several steps including whether to initiate any enforcement actions in consultation with its federal and state partners.
Can I import or export cannabis-containing or cannabis-derived products?
According to FDA:
“Regarding imports, if it appears that an article is adulterated, misbranded, in violation of section 505 of the FD&C Act, or prohibited from introduction or delivery for introduction into interstate commerce under section 301(ll) of the FD&C Act, such article will be refused admission (see section 801(a)(3) of the FD&C Act [21 U.S.C. § 381(a)(3)]).”
General information about the import/export of drug products regulated by FDA can be found online here. In addition, anyone considering importing CBD should learn more about the DEA requirements.”
The FDA generally decides issues about the manufacturing, distribution, and marketing of CBD products based on the Food, Drug, and Cosmetic Act. For now, there is only CBD-based product, Epidiolex, that has been approved as a new drug. An Investigational New Drug application (IND) is quite expensive due to the scientific requirements.
Contact Cohen Healthcare Law Group, PC to review your duty to comply with FDA regulations regarding manufacturing, selling, and promoting CBD products and ways to mitigate potential violations through compliance efforts that make sense in light of your marketing.