Boston Globe slams DSHEA and 'powerless' FDA

The Boston Globe has called for a repeal of DSHEA, stating that the US Food and Drug Administration (FDA) is “virtually powerless” in regulating the industry.

“With vitamins and supplements now used by 114 million Americans, Congress should end its 15-year experiment with lax regulation of the industry,” states the Globe’s editorial. “It hasn’t worked.”

Despite the existence of DSHEA, the editorial claims that supplements are ‘unregulated’, with “many of its products contain illegal synthetic steroids that can damage livers or kidneys and cause strokes or lung blood clots”.

In an editorial published yesterday, the Globe cites a recent article in the New England Journal of Medicine by Harvard Medical School’s Pieter Cohen, which claimed that contamination has been identified in over 140 products. Contaminants reportedly included heavy metal, prescription medications, and toxic plant material.

“Under the current law, the FDA can take action against manufacturers of supplements with harmful ingredients only after there are reports of bad reactions among users. But for the most part it can’t require firms to show that their products are safe before they go on the market,” says the editorial. “That’s an enormous loophole, given that the damage caused by steroids tends to become apparent only after long periods of use.”

Reaction

Industry has reacted strongly to the editorial, which represents the latest in a series of high profile attacks by the mainstream media in recent months.

Daniel Fabricant, PhD, director of scientific and regulatory affairs for the Natural Products Association (NPA) told NutraIngredients-USA that it was clear that many people did not understand how the industry is regulated. "The regulation is not lax," said Fabricant. “It is tightly regulated.”

Judy Blatman, senior vice president, communications for the Council for Responsible Nutrition (CRN) told NutraIngredients-USA.com that it was a shame the Boston Globe “didn’t check with anyone integrally involved with dietary supplement regulation before running their editorial”.

“The problem we keep facing as an industry is that there are a small number of outliers who keep finding ways to escape the law—but if they’re not following the current law, what makes anyone think they would follow a new law?” said Blatman.

Like NPA, CRN are seeking to engage the newspaper’s editors to “explain what regulations are in place and why they’re appropriate for the dietary supplement industry and its consumers”.

“Regulation is complex, and the typical reaction that ‘we need to get some new laws or regulations in place,’ is a simplistic answer that will just add more bureaucracy and not eliminate criminal activity,” she said.

“What we need is FDA to take strong and swift action again companies selling steroids that pretend to be dietary supplements. FDA’s Dr. Joshua Sharfstein spoke last week at CRN’s annual conference, and we were encouraged by his determination to use all the tools available to the agency under DSHEA. We think we’re going to see FDA come out even more strongly against companies who are not following the law,” added Blatman.

Earlier this year DSHEA was slammed in a number of mainstream press articles and blogs, including the LA Times, Sports Illustrated, SFGate, The Journal of the Federation of American Societies for Experimental Biology (FASEB), and the Herald Tribune.

To read the Boston Globe article, please click here.

To read our earlier coverage of the other media articles, please click here.