U.S. Marshals, acting on behalf of the U.S. Food and Drug Administration (FDA), have seized multiple dietary supplement products from a Florida distributor (Globe All Wellness, LLC.) on the grounds that the products are unapproved new drugs and contain illegal and undeclared active pharmaceutical ingredients.
The distinction between dietary supplements and drugs is often confusing. A better understanding of the Federal Food, Drug, and Cosmetic Act (from which FDA derives its authority) can help clarify the situation. The Federal Food, Drug, and Cosmetic Act (FDCA) has specific regulatory definitions for “dietary supplement” and “drug.” FDCA defines “dietary supplement” as a product “intended to supplement the diet and contains one or more of the following: a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use to supplement the diet by increasing total dietary intake; or a concentrate, metabolite, constituent, extract or combination of any the aforementioned; is intended for ingestion as a tablet, capsule, powder, softgel, gelcap, or liquid form, or if not intended for ingestion in such a form, is not represented as conventional food and is not represented for use as a sole item of a meal or of the diet” (Sec. 201(ff)). Dietary supplements may not contain an ingredient authorized for investigation as a new drug, unless the ingredient was previously marketed in a dietary supplement or food. FDCA defines drugs as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals” (Sec. 201(g)(1)). Drugs must be formally approved by FDA or be the subject of a monograph published by the agency’s OTC Drug Review Panel.
Dietary supplements are permitted to make specific claims related to the structure and function of the body. These “structure/function” claims describe the role of a nutrient or dietary ingredient intended to affect normal structure or function in humans, characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function, describe general well-being from consumption of a nutrient or dietary ingredient, or describe a benefit related to a nutrient deficiency disease. Generally, dietary supplements may make claims to support or maintain normal structure or function of the body, but cannot make claims to affect such structure or function. Claims that exceed what FDA considers appropriate for a dietary supplement can cause the agency to brand a product an “unapproved new drug.”
FDA had previously inspected a Globe All Wellness facility and found multiple violations related to these regulatory issues. The firm’s product labels include claims that exceeded those deemed appropriate for a dietary supplement (“deliver peak sexual experience”… “lose 20 pounds in a month!”). During the course of the inspection, FDA also tested the products and found undeclared active pharmaceutical ingredients: sibutramine (Meridia) and sildenafil (Viagra). Both had previously been approved by FDA as prescription drug active ingredients and therefore were inappropriate for use in a dietary supplement. In addition, Meridia had been pulled from the market due to safety concerns related to increased risk of heart attack and stroke. Seizure was deemed necessary to prevent misbranded and adulterated drugs from entering the market. As this situation shows, FDA will resort to aggressive enforcement actions in order to protect public health and ensure that food and drug regulations are followed.
In order to reduce the risk of FDA enforcement actions on their products, companies should consider having their dietary ingredients and labeling claims reviewed by Registrar Corp’s team of Regulatory Specialists. If you have questions regarding FDA compliant labeling and formulations for your particular product, simply contact Registrar Corp 24/7 via Live Help or call Registrar Corp’s U.S. Office at: +1-757-224-0177. To receive regular regulatory updates, follow Registrar Corp on Twitter: @RegistrarCorp
*Learn more about What Makes a Food a Dietary Supplement