Introduction

Dietary supplements, unlike brand and generic drugs, do not require premarketing approval from the FDA and are considered “unregulated drugs that do not have a consistent dosage from batch to batch.” By law, the FDA must investigate a product if a safety issue is reported. If the investigation provides sufficient evidence that the product is unsafe, the FDA must then protect the public by banning the product from the market. The FDA is required to conduct a legal investigation into ALL adverse events with regard to dietary supplements due to their approval exception. The first step the FDA takes, after their initial investigation, is to send a letter to the company warning them about a possible injunction if the ingredient in the product is not immediately removed. Once a response is received, the FDA can then proceed with immediate action.

Background

The use of dietary supplements has become an exciting trend among dieters to enhance performance and increase energy. However, what consumers may not know is that the FDA does not regulate all products being sold. The dietary supplement DMAA (1,3-dimethylamylamine) is a synthetic drug originally intended as a nasal decongestant. Recently, DMAA has been used for the purpose of weight loss, increased athletic performance, and body building. In 2010, DMAA was added to the World Anti-Doping Agency’s “prohibited substance list.” The FDA advised competitive athletes to avoid using products containing DMAA due to safety concerns, as the drug has been reportedly linked to life-threatening side effects. Reports have shown that people using dietary supplements containing DMAA have experienced elevated blood pressure, shortness of breath, tightening of the chest, seizures, and heart attacks. Promoters of DMAA initially claimed that the drug is a safe alternative to ephedrine; however, there was no scientific data to support the promoters’ claim.

Issue

Should dietary supplements follow the same approval process as brand-name and generic pharmaceutical drugs before being put on the market?

Rule

Dietary supplements should follow the same approval process as brand-name and generic pharmaceutical drugs before being put on the market if:

  1. They have the same possible risks to users’ health.

Analysis

The FDA, as of April 30, 2013, has received a total of 86 adverse reports regarding dietary products containing the drug DMAA. A total of 11 US companies have received warning letters from the FDA insisting that any products containing DMAA must be removed from the market and are now considered illegal. Out of the 11 companies, 10 have agreed to remove the product. The company, USPlabs, initially decided to challenge the findings provided by the FDA and submitted studies attempting to disprove the safety threat of DMAA in their products. However, after a thorough review of the studies, the FDA concluded that the data provided by USPlabs was “insufficient to defend the use of DMAA as an ingredient in dietary supplements.” Therefore, USPlabs has agreed to “phase out” any dietary products containing DMAA and will reformulate any future products before selling them.

Conclusion

If the FDA were to change the approval standards to include dietary products, adverse reactions regarding drugs similar to DMAA would happen less frequently. The general public may assume all products being sold are regulated and may continue to be ignorant to the fine-print facts behind the drug approval process. Because of their risk to users’ health, dietary supplements should follow the same approval process as other drugs before being put on the market.

For more information on this issue, contact the Kulkarni Law Firm.