On September 4, 2020 Representative Kurt Schrader (D-OR) and Representative Morgan Griffith (R-VA) introduced the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2020 (the “Act”). The Act would make hemp derivatives, including hemp-derived CBD (“Hemp CBD”), lawful for use as a dietary ingredient in a dietary supplement.
A dietary supplement is a product, taken by mouth, that contain a dietary ingredient. Dietary ingredients include vitamins, minerals, amino acids, herbs or other botanicals that can be used to supplement the diet. If you have stepped into a grocery store or pharmacy in the US in the last 25 years, you’re probably already familiar with dietary supplements. Think about the bottle of Vitamin C tablets that is sitting in your medicine cabinet. That’s a dietary supplement
The Food and Drug Administration (“FDA”) has long held that Hemp CBD cannot be sold as a dietary supplement. The FDA regulates a wide variety of products including food, drugs, cosmetics, and (you guessed it) dietary supplements. The FDA’s position on Hemp CBD has to do with the “Drug Exclusion Rule” which prohibits a substance that is an active ingredient in a drug from being added to a food or dietary supplement unless the substance was marketed as a food or dietary supplement before it was investigated as a drug.
The FDA has approved CBD as an active ingredient in a drug, Epidiolex. According to the FDA’s Cannabis FAQs, the FDA has concluded “based on available evidence” that CBD was not marketed as a dietary supplement before CBD was investigated as a drug. Therefore, it cannot be legally marketed as a dietary supplement.
The Act would essentially carve out Hemp CBD from the Drug Exclusion Rule. Remember, the Act is only proposed legislation at this point. In order to become law, the Act would have to pass the House of Representatives and the Senate and then be signed into law by the President. In addition, the Act would become effective 90 days after enacted, meaning that if passed, hemp derivatives including Hemp CBD, would not become lawful dietary ingredients immediately.
The Act would require that hemp derivates marketed as dietary supplements comply with the regulatory framework that currently exists for dietary supplements. Specifically, the Act references 21 USC 350b the section of the code that governs “New Dietary Ingredients.” A new dietary ingredient means a “dietary ingredient that was not marketed in the United States before October 15, 1994 and does not include any dietary ingredient which was marketed in the United States before October 15, 1994.” If you are wondering why that 1994 date is relevant, that is because that is the year the U.S. enacted the Dietary Supplement Health and Education Act, so there are some carve outs for supplements that were marketed prior to that date.
Prior to the 2014 Farm Bill, it was not legal to grow hemp or sell hemp derivatives (other than a few hemp-seed products) in the US due to the Controlled Substance Act. That means hemp derivatives could not have been lawfully marketed in the U.S. before 1994 and would be considered new dietary ingredients.
Manufacturers and distributors of new dietary ingredients must notify the FDA prior to marketing the dietary supplement containing the new ingredient. This notification period lasts 75 days. Manufacturers and distributors must ensure that their products are safe when used in accordance with the recommended or suggested use, shown on a product’s label and must provide the FDA “with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.” 21 USC 350b. The FDA may object to the manufacturer or distributor’s new dietary ingredient, may issue a no objection letter, or may decline to respond at all. If the FDA issues a no objection letter or fails to respond, then the manufacturer or distributor may move forward with the dietary supplement.
The Act would also require that Hemp CBD dietary supplements be labeled and manufactured in accordance with FDA regulations. The FDA has provided guidance on dietary supplement labeling here. In addition, manufacturers and distributors of Hemp CBD dietary supplements would be prohibited from making disease claims about their products. This means any claim to diagnose, cure, mitigate, treat, or prevent disease.
However, distributors and manufacturers would be allowed to make structure/function claims, claims of general well-being, and claims related to nutrient deficiency claims. In guidance provided to the dietary supplement industry, here is how the FDA sorts out those claims:
- Structure/function claims may describe the role of a nutrient or dietary ingredient intended to affect the normal structure or function of the human body, for example, "calcium builds strong bones." In addition, they may characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function, for example, "fiber maintains bowel regularity," or "antioxidants maintain cell integrity." General well-being claims describe general well-being from consumption of a nutrient or dietary ingredient. Nutrient deficiency disease claims describe a benefit related to a nutrient deficiency disease (like vitamin C and scurvy), but such claims are allowed only if they also say how widespread the disease is in the United States.
The FDA does not pre-approve these types of claims, but manufacturers of dietary supplements must have substantiation that the claim is truthful and not misleading and must submit a notification of the claim to the FDA within thirty days of making such a claim. The manufacturer must also include a disclaimer stating that the FDA has not evaluated these claims and that the product is not intended to "diagnose, treat, cure or prevent any disease.”
Currently, the FDA’s position is that Hemp CBD cannot be marketed as a dietary supplement. Therefore, manufacturers and distributors of Hemp CBD cannot make any type of health and wellness claims about Hemp CBD. If the Act passes, it would have a huge impact on the way that Hemp CBD can be marketed. However, with power comes great responsibility as manufacturers and distributors of Hemp CBD would no longer be operating in the “wild west” and would be required to follow FDA regulations regarding dietary supplements. We will monitor the Act and provide updates as they become available.
You can contact Daniel Shortt at email@example.com.