A prominent member of the Cambridge Health Alliance and Harvard Medical School says DSHEA needs urgent reform because it is holding the FDA back from ensuring that dietary supplements are safe.
Responding in the New England Journal of Medicine (NEJM) to the recent Senate sub-committee on contaminants, Pieter A. Cohen, M.D, said the 1994 Dietary Supplements and Health Education Act (DSHEA) was the wrong regulatory model and should be amended or scrapped.
“DSHEA presents serious obstacles to the FDA’s ability to detect and eliminate contaminated supplements. A wide range of dietary supplements have been found to be contaminated with toxic plant material, heavy metals, or bacteria,” Dr Cohen wrote.
“The DSHEA has not ensured that hazardous dietary supplements will be identified or removed from the market in a timely fashion. I believe that Congress should give the FDA the requisite authority and resources to regulate dietary supplements so that the public can make well-informed decisions regarding the potential risks and benefits of consuming such supplements. Until that happens, millions of Americans will continue to be exposed to unacceptable risks in exchange for purported but unproven health benefits.”
Nothing to see here
Dan Fabricant, PhD, acting executive director of the Natural Products Association, said Dr Cohen’s comments pointed the finger at the dietary supplements when the pharmaceutical industry was equally culpable of the type of steroid and contaminant issues raised at the Senate meeting.
“This is the kind of call that has been made regularly against DSHEA when the problem is the lack of resources at the disposal of the FDA,” he told NutraIngredients.com.
“It is the kind of attack that shows no working knowledge of the industry, its products and the law. These kinds of comments tend to appear when there is a media circus around an event like the Senate hearing but they are nothing we have not heard before.”
Dr Fabricant said the Senate hearing had been beneficial because it had distinguished the righteous players in the industry from the “criminals that do not represent this industry”.
“Yes there is a lot of work to do but the bottom line is the FDA needs more resources. There have been more actions taken this year so things are moving in the right direction but more needs to happen after twelve years of budget cuts.”
More and more
Dr Cohen acknowledged that the Food and Drug Administration was being more proactive with 140 contaminated products identified, but said its lack of resources, “created a marketplace in which manufacturers can introduce hazardous new products with virtual impunity.”
Newly introduced adverse event reporting (AER) was also capturing only a miniscule number of the estimated 50,000 AERs each year.
“Of particular concern are the dozens of dietary supplements that are contaminated with prescription medications, controlled substances, experimental compounds, or drugs rejected by the FDA because of safety concerns,” he said.
“These potentially hazardous ingredients have been detected in products marketed for patients with diabetes, high cholesterol, or insomnia but are most frequently found in products that promise sexual enhancement, optimal athletic performance, and weight loss.
Hide and seek
He said contaminants such as sibutramine, rimonabant, fenproporex, furosemide, benzodiazepines and antidepressants had been detected and contamination methods were becoming more sophisticated.
“Analogues are created by modifying the original chemical structure of a compound — for example, by adding a hydroxyl group. It is suspected that these analogues are developed to evade detection by the FDA, making the products more difficult to regulate, and to reduce the risk of patent-infringement lawsuits.
“A recent analysis showed that more than half of 26 supplements marketed for the enhancement of sexual function contained analogues of phosphodiesterase type 5 inhibitors.
Because these analogues have never been studied in humans, their risks are unknown, but unexpected adverse reactions to analogues have already been documented. Reports from Britain, China, and Japan, for instance, link an analogue of fenfluramine to liver damage, including fulminant hepatic failure necessitating transplantation.”