New Proposal Seeks to Toughen FDA Regulations on Dietary Supplement Industry

Recent years have witnessed an onslaught of highly questionable products reach the U.S. market via the dietary supplement industry. The release of such ambiguous products has been responsible for an influx of tainted dietary supplements, each of which may pose as a significant threat to the consumer population. Subsequently, lenient regulations imposed by the U.S. Food and Drug Administration (FDA) have neglected to rid the industry of these potentially dangerous products. However, a new proposal has been introduced that may prove to strengthen the FDA’s power to regulate dietary supplements.

The dietary supplement industry currently generates approximately $28-billion-a-year through the development of countless products whose safety and efficacy are more than questionable. Continuing with a tradition steeped in ambiguity, the dietary supplement industry continues to release “novel” products that promote promising results through the use of minerals, plants and amino acids. However, lenient regulations imposed by the FDA do not go nearly far enough in preventing manufacturers from supplementing their products with undisclosed ingredients.

Countless products are released into interstate commerce that boast revolutionary treatments, the majority of which are no more than “mega-doses” of previously released dietary supplements. However, a lack of enforced rules allows manufacturers to release products without the burden of further regulations. As a result, an influx of questionable products are flooding the market. An industry that produced and marketed 4,000 distinct products in 1994, when the regulatory framework for dietary supplements was written into law, now markets about 55,000 products to Americans who believe them to be safe to take.

Regulations imposed in 1994 require the makers of dietary supplements to provide federal regulators with evidence supporting a product’s “reasonable expectation of safety.” However, proponents of reform suggest that these regulations are no more than archaic and neglect to adapt to the dietary supplement industry as it exhibits a propensity for exponential growth. According to Dr. Pieter Cohen, assistant professor of Medicine at Harvard University, the 1994 regulations have gone unenforced by the FDA and likely ignored by manufacturers.

In an effort to maintain a respectable level of standards, representatives from the FDA have proposed a new set of regulations. The new set of rules, proposed last July, would correspond with the ever changing market of dietary supplements. According to the new rules, a “reasonable expectation of safety” should be established. The FDA would require documentation of a supplement’s “historical use” outside the United States. For “mega-doses” that exceed commonly used levels of a given supplement, the agency wants to see evidence of safety from animal studies and subsequent test-tube studies.

Contradictory to the beliefs of the FDA however, are those of Dr. Cohen. In an article published in the British Medical Journal, Dr. Cohen acknowledged that the historical use of a product where no one is looking for possible ill effects is a standard too low to assure safety, suggesting the new standards will not work. He adds that supplement manufacturers are under no obligation to share unfavorable safety data on a product with the FDA, so long as they offer studies that show the product is safe.

Do I Have a Dietary Supplement Lawsuit?

The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in dietary supplement lawsuits. We are currently accepting new cases in all 50 states.

If you or a loved one has been injured by a dietary supplement, you may be entitled to financial compensation. For a free case review, please click the link below or call toll free 24 hrs/day 1-(949) 557-5800.