October 12, 2018

FEATURED ISSUE
How supplements become drugs
Two years ago, AHHA performed an in-depth review of the U.S. Food and Drug Association (FDA)regulations for New Dietary Ingredients (NDI) and shared the referenced regulations in our September 2016 Issue. A concern raised at that time is still unresolved. If a drug company begins investigating a nutrient for use in a drug before a supplement company files an NDI notification on that nutrient, the drug company can ask the FDA to have supplement version removed from the market, leaving consumers with no other option than the drug.In 2016, we cited this question and answer from page 42 of the Dietary Supplements: New Dietary Ingredient Notifications and Related Issues: Guidance for Industry of this guide, we note:

May I use an ingredient in a dietary supplement if it has been clinically tested as a drug but has not been approved as a drug in the U.S.? The general rule is that an article that was authorized for investigation as a new drug or as a biologic before being marketed as a food or as a dietary supplement cannot be marketed as a dietary supplement if substantial clinical investigations of the article have begun and the existence of such investigations has been made public.

AHHA’s comment in 2016 was that this seemed to be an unusual item to include in this document. So we searched to learn whether this has ever happened. We found that theFDA had approved a drug company’s request for a form of natural vitamin B6 to be in a drug research trial(and B6 was thus banned from use in dietary supplements) because the FDA ruled it did not qualify for the pre-1994 DI exemption. “Even when an IND [Investigational New Drug] is rescinded, or when it does not lead to a new drug, the supplement form is still banned.”

Now, in 2018, there are indications that the natural supplements L-glutamine and CBD oil may become “drugs.”The FDA has progressed to the approval stage for two new drugs with active ingredients of these two natural supplements. Will these natural compounds remain available as supplements or will they become only available by prescription?

ISSUE: Do natural supplements need to be protected from FDA designated as drugs?

AHHA strives to maintain a neutral position on issues and viewsknowledge as power. For those interested in learning more about this month’s issue, the following related articles were selected to serve as a foundation for becoming aware of the two sides of this matter.

FDA notices:
FDA approved L-glutamine powder for the treatment of sickle cell disease (8/18/17)
U.S. Food & Drug Administration

FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy (6/25/18)
U.S. Food & Drug Administration

ANH concerns:
FDA Turned Your $10 Supplement into a $40,000 Drug  (10/4/18)
Alliance for Natural Health USA

FDA Back Channel Lets Pharma Turn Nutrients Into Drugs (2/15/18)
Alliance for Natural Health USA

We encourage you to go to our blog at https://ahha.org/blog and post your comments. You are invited to share additional resources you have found relating to this issue.

To review past ISSUES, visit the Special Updates Archives.