December 18, 2015 · FLEMING | NOLEN | JEZ, L.L.P.
By Greg Brown
2015 was another hugely successful year for the dietary supplement business. Dietary supplements have become big business for many companies in this industry. For 2015, sales of dietary supplements are estimated to have increased by 2.5-3% industry-wide. However, there are growing concerns about a lack of oversight to these products.
While dietary supplements are regulated by the Food and Drug Administration (“FDA”), they are not regulated in the same manner as drug products. First, supplements are usually not FDA-approved before entering the market. There is also no legal requirement that a dietary supplement manufacturer demonstrate safety and efficacy of its product before it. Unlike drugs, dietary supplements are regulated under the Dietary Supplement and Health and Education Act of 1994 (DSHEA). Under this law, manufacturers and distributors of dietary supplements are simply prohibited from making products that are “adulterated” or “misbranded.” FDA only steps in “after [products] reaches the market.” The direct result is weak oversight of dietary supplements.
There is now growing concern that a number of dietary supplements that are found to be either non-effective or pose serious health risks including but not limited to the following ingredients:
- Gingko biloba – an extract made from leaves of a tree commonly found in China
- Garcinia cambogia – otherwise known as tamarind fruit
- St. John’s wort – frequently used to treat depression
- Gucosamin and chonroitin – commonly used to treat joint pain
- Echinacea – a flower similar to a daisy, used to treat the common cold.
More dietary supplement manufacturers are facing emerging controversies. A recent article from The New England Journal of Medicine concluded that dietary supplements sent an estimated 23,000 Americans to emergency rooms and caused 2,000 people to be hospitalized from 2004-2013.
Recently, a company called Reesna recalled all Fuel Up and Fuel Up Octane dietary supplements because they contain hydroxythiohomosildenafil. This ingredient is derivative of sildenafil, a prescription drug used to treat erectile dysfunction (i.e. Viagra). Because this is an unapproved use, Reensa was forced to pull these products from the market.
As a result of the lax rules applicable to dietary supplement products, there have been rising problems and concerns. Many dietary supplement manufacturer have blatantly taken advantage of this lack of oversight. Only recently have various groups pushed back. Recently, a coalition of various state attorneys general joined New York Attorney General Eric Scheiderman in efforts to “eliminate misleading and deceptive labeling for the benefit of consumers” as stated by a press release from Indiana Attorney General Greg Zoeller. Additionally, the State of Oregon filed a lawsuit against GNC over selling supplements containing picamilon and BMPEA. Picamilon is described as a neurological drug, while BMPEA is an amphetamine-like substance.
In all probability, with the rapid growth of the dietary supplement industry there are likely to be more cases of personal injury and/or consumer fraud. If you or a loved one have taken a dietary supplement product that you believe is non-effective or has caused personal injury, contact Fleming, Nolen & Jez LLP for a free consultation.