Regulating CBD As A Dietary Supplement: What Does This Mean?

By Andrew J. Neiman, Associate Attorney, Fortis Law Partners.

A new House bill (H.R. 5587), introduced on January 13, 2020 calls for amending the Federal Food, Drug, and Cosmetic Act to change the way the Food and Drug Administration regulates hemp derived CBD products. Specifically, the bill would order the FDA to allow the marketing of cannabidiol (“CBD”) as a dietary supplement and food additive.

Specifically, the bill would amend Section 201(ff)(3)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(ff)(3)(B)) by inserting “(other than hemp-derived cannabidiol or a hemp-derived cannabidiol containing substance)” after “an article”. Section 201(ff)(3)(B) would therefore state that “[t]he term "dietary supplement". . . does. . . not include. . . an article [other than hemp-derived cannabidiol or a hemp-derived cannabidiol containing substance]  that is approved as a new drug under section 355 of this title. . .”

A “dietary supplement” is a class of products, such as vitamins, that may be legally sold to consumers without the rigorous testing that the FDA requires for pharmaceuticals. For example, Federal Law does not require that companies prove that dietary supplements are safe before they are marketed, nor does it require that companies prove that claims made on product labels are accurate or truthful before they appear on the product. However, if the claim made on the product label is a health claim, the health claim must be proven by scientific evidence. In fact, the FDA’s role with respect to dietary supplements begins after the product enters the marketplace, and its principal responsibilities are related to safety monitoring. Dietary supplements can help patients get adequate amounts of essential nutrients, improve overall health, and help manage some health conditions, and risks such as side effects only occur if they are used improperly or instead of prescribed medications.

Alternately, if CBD products are regulated as drugs, a CBD-product manufacturer may be required to submit a New Drug Application (NDA), in which it must perform laboratory and animal tests to discover how the drug works and whether it's likely to be safe and work well in humans. Then, the company must undergo clinical trials to evaluate whether the drug is safe and effective in its proposed use, and whether the benefits of the drug outweigh the risks. Clinical trials may also be used to determine whether the proposed label is appropriate, and whether the proposed quality control methods are sufficient to preserve the drug's identity, strength, quality, and purity. This approval process is costly for companies; the median cost of these clinical trials for NDA is $19 million and the average total cost of developing a new drug is estimated at between $2 to $3 billion. Still, nearly one-third of new drugs have been found to have safety problems after FDA approval.

CBD-product manufacturers who want to make health claims still must obtain FDA approval for these claims. Health claims are statements about the relationship between a specific food or food component and a disease intended to assist the consumer in maintaining healthful dietary practices. Manufacturers of dietary supplements may make a health claim if in the FDA’s best judgment, qualified experts would likely agree that the scientific evidence supports the substance/disease relationship that is the subject of a proposed health claim. This is based on an evidence based review system, whereby the FDA will assess scientific studies and other data, eliminate those from which no conclusions about the substance/disease relationship can be drawn, rate the remaining studies for methodological quality and evaluate the strength of the totality of scientific evidence. Consideration is given to study types, methodological quality, quantity of evidence for and against the claim, relevance to the U.S. population or target subgroup, replication of study results supporting the proposed claim, and overall consistency of the evidence.

If the bill were to fail, manufacturers of CBD products would continue to face uncertainty regarding the legal status of CBD. The bill will benefit smaller hemp companies by removing regulatory and market barriers, and by providing certainty as to how the FDA must treat hemp-based CBD products. The bill has a strong probability of success in the House and this has already been reflected in rising stock prices in CBD companies. The bill has bipartisan support and is sponsored by Thomas Massie (R-KY), James Comer (R-KY) and Chellie Pingree (D-ME). If the bill were to pass, it has the potential to make more hemp-derived CBD products available to consumers.

Photo by Javier Hasse.

The preceding article is from one of our external contributors. It does not represent the opinion of Benzinga and has not been edited.