Concern About Conflicts of Interest in FDA Dietary Supplement Regulators

Concern About Conflicts of Interest in FDA Regulators

Concern About Conflicts of Interest in FDA Regulators

The Food and Drug Administration (FDA) is facing criticism of its regulation of dietary supplements containing a dangerous stimulant. The stimulant is BMPEA, a chemical nearly identical to amphetamine. BPMEA is added to weight-loss and workout products to enhance their effect.

BPMEA has never been tested for safety and effectiveness in humans and is not a permissible ingredient in dietary supplements. The FDA was the first agency to suspect that BMPEA had been added to supplements that listed the little-known plant acacia rigidula among the ingredients. Experts say that plant listings like this are often an indication that the manufacturer is trying to disguise a chemical additive as a natural botanical extract, the New York Times reports.

The agency tested 21 supplements that listed acacia rigidula on their labels: nine of them contained BMPEA. But the FDA did not recall the products, or issue a health alert, or even name them to the public. Canadian health authorities, in contrast, saying such supplements posed “a serious health risk,” issued a public health alert and forced a recall of JetFuel Superburn, which contained not only BMPEA but also another amphetamine-like stimulant. According to the Canadian warning, these stimulants can increase blood pressure and heart rate and lead to serious cardiovascular complications (including stroke). They “can suppress sleep and appetite, and be addictive,” Health Canada warned in December.

Critics attribute the FDA’s slow response to the fact that the recent past head of the supplements division, Dr. Daniel Fabricant, and the current head, Dr. Cara Welch, came to the FDA from the Natural Products Association, an industry trade group. Fabricant headed the supplements division from early 2011 until spring 2014, when he returned to the association as its chief executive, according to the Times.

Troubled by the FDA’s inaction on BPMEA, Dr. Pieter Cohen, an assistant professor at Harvard Medical School, and other researchers conducted their own tests on supplements. Their results, published last week, identified BMPEA in 11 of 21 supplements that listed acacia rigidula as an ingredient. The researchers urged the immediate recall of all supplements containing BMPEA. Another industry trade group, the Council for Responsible Nutrition, also urged the FDA to remove BMPEAA-containing products from the market “before there are serious health consequences.” The Times reports that some vitamin stores began voluntarily removing the supplements from the shelves.

The FDA says it hires people from the supplements industry because it needs experts from diverse backgrounds. But consumer advocates warn that putting industry people in key regulatory positions is like appointing the fox to guard the henhouse. The Times recommends that Congress enact conflict-of-interest laws requiring employees above a certain grade level at any agency to recuse themselves from official actions that affect a former employer or client, including trade associations and their members.

Read more at: http://www.yourlawyer.com/articles/title/top-fda-officials-have-ties-to-supplement-industry

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