Dietary Supplement Lawsuit in Texas

The New England Journal of Medicine has published an editorial by Dr. Pieter Cohen, who argues that the U.S. Food and Drug Administration (FDA) guidelines proposed in July 2011 do not go far enough to regulate new ingredients in dietary supplements. As a result, Cohen argues that the public cannot be assured that they will be safe from new ingredients that have not been proven to be safe.

In 1994, the Dietary Supplement Health and Education Act was passed. Dietary supplements containing “established ingredients” were exempt from pre-market safety studies. By law, dietary supplement manufacturers who wanted to sell products containing “new ingredients” had to submit safety data to the FDA before the products could be sold.

Unfortunately, in the 18 years since the law passed, the FDA has not been able to enforce this rule effectively, leading to a situation where there may be thousands of dietary supplements that contain new ingredients that have never been tested for safety or efficacy in scientific, clinical studies.

Since 1994, the number of dietary supplements has increased from 4,000 to 55,000 products. Yet the FDA has only received 170 notifications of “new ingredients” with safety data, “undoubtedly a small fraction of the ingredients for which safety data should have been submitted,” wrote Dr. Cohen.

In response to the situation, in July 2011, FDA created a lengthy proposal for new guidelines that would clarify what constitutes a “new ingredient”.

Dr. Cohen argues that these proposed guidelines do not go far enough to protect the public from unsafe new ingredients.

The safety of a dietary supplement would be based on the following factors:

  • Documented history of use (if the ingredient has a long history of use in foods, supplements, or herbal medicine)
  • Formulation and proposed daily dose (if the proposed dose exceeds historical ingestion rates, the FDA would require safety testing)
  • Recommended duration of use

The FDA guidelines would require that synthetically derived versions of botanical compounds would be considered new. In addition, supplements that contain significantly higher doses than was historically ingested would be required to conduct safety tests in animals and people.

Cohen sees the biggest problem with the “documented history of use.” A manufacturer could claim that historical data proves a new supplement ingredient is safe, thus avoiding an expensive clinical trial. But simply because an ingredient was used in the past does not prove that it is safe. Under the proposed guidelines, manufacturers would not even be required to conduct single-dose tolerability studies in humans before selling the products. In addition, even if manufacturers conduct safety studies, the FDA guidelines do not require them to submit all data. The manufacturers could potentially cherry-pick the data that is favorable to their product.

Dietary supplement industry advocates say that the FDA is going too far in its proposed regulations. They say that the law protects them from heightened scrutiny that approaches the level of a food additive. Cohen argues that the industry argument is invalid, because the FDA has a long-established authority to police new ingredients with heightened scrutiny. The protection under DSHEA only covers “established ingredients.”

The case of DMAA is a good example of problems with “historical” data. DMAA dietary supplements were sold as work-out boosters and stimulants, and they were later linked to cardiovascular problems and several deaths in soldiers who took the supplements before training. The active ingredient in DMAA is a synthetic chemical, but because there was a questionable Chinese historical study that linked the chemical to geranium, the chemical was often listed on ingredient labels as “geranium extract.”

More than 100 million people use a dietary supplement in the U.S., spending around $28 billion on the products every year. Dietary supplements include vitamins, minerals, herbal ingredients, and other products. Cohen argues that people cannot be assured that the products are safe or effective because the FDA cannot assure the safety of new ingredients.

How do I contact a Lawyer in Texas for a Dietary Supplement Lawsuit?

For a free consultation, please contact Collen A. Clark at The Clark Firm, LLP immediately. You may be entitled to compensation by filing a lawsuit.

Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”

The Clark Firm has assembled a team of trial lawyers with more that 100 years experience, participation in over 600 jury trials and $60 million in verdicts and/or settlements. Please use the form below to contact a lawyer in Texas for a free Dietary Supplement lawsuit review.