Former Supplement Officials Regulate Supplements at FDA

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Meet the New Snake Oil, Same as the Old Snake Oil

By Michael Jacobson, Executive Director, Center for Science in the Public Interest

During the administration of President Woodrow Wilson, government investigators performed laboratory tests of Clark Stanley’s Snake Oil Liniment — a potion supposedly made of rattlesnake oil that offered “immediate relief” for rheumatism, sciatica, sprains, lumbago, deafness, and other ailments. The tests found that the liquid contained not the advertised reptile juice, but rather mineral oil, red pepper, turpentine, and other ingredients. The government sued Mr. Stanley, winning a $20 judgment, and “snake oil” became shorthand for any false or fraudulent cure.

No longer the exclusive province of carnival barkers and traveling salesmen, the snake oil of today is made by countless companies and sold at GNC, Target, Walgreens, Walmart, and thousands of other retailers on and off the Web. I’m referring to dietary supplements, products such as echinacea, ginseng, ginkgo biloba, and other “herbs,” variously marketed to provide relief from colds, enhance stamina, improve memory, relieve aching joints, or deliver other benefits.

As it turns out, questions have been raised about whether the specified herb is even present in some of these supplements. DNA tests ordered by New York State Attorney General Eric T. Schneiderman found that store brands of supplements at those four national retailers often did not contain DNA evidence of the herb advertised on the label. The industry claims DNA barcoding is not the appropriate method to test refined herbal extracts. Regardless, the industry is having a harder time explaining why New York’s testing found DNA evidence of rice, beans, pine, wheat, nuts, or even house plants in these supposedly pure products.

A recent agreement that Schneiderman’s office reached with GNC requires that company to perform DNA barcode testing of its pre-extraction ingredients, to test products for allergens, and to adhere to rigorous production protocols. Those are landmark steps, and I hope that the rest of the industry is persuaded — or forced — to adopt similar practices. But even the testing that the attorney general insisted on won’t prevent doctoring of the final products.

More broadly, though, the dietary supplement industry is still a mess.

Americans spend an estimated $33 billion a year on dietary supplements, including $6 billion on herbal supplements. It’s not entirely a waste of money. Some Americans do have vitamin or mineral deficiencies that might benefit from a multivitamin. A handful of other supplements do at least have some scientific evidence to suggest a benefit for certain conditions. Supplements with phytosterols can help reduce cholesterol levels, for instance. Many Americans would benefit from additional calcium, vitamin D, or B-12. In one major study a daily multi actually reduced cancer risk by 10 percent.

But in the case of most herbal supplements, even if the advertised herb was in the pill, the evidence that the herbs provide the advertised benefit ranges from inconsistent to flimsy to non-existent. That’s certainly true in the case of ginkgo biloba, which is marketed to improve memory. It doesn’t. In fact, there’s stronger evidence that that particular herb causes harm (a government study found that it caused cancer in lab mice and possibly in rats) than there is for the memory benefits. Black cohosh is purported to have benefits for women experiencing menopause, but that herb may promote liver failure. Some dietary supplements marketed as erectile-dysfunction aids were found to have been contaminated with undisclosed pharmaceutical compounds. Even large amounts of beta-carotene, which the body converts to vitamin A, might not be appropriate for everyone: it increases the risk of lung cancer in smokers and former smokers.

Unfortunately, regulators at the Food and Drug Administration aren’t doing much to police the claims being made by supplement manufacturers, which wield too much influence at the agency. The acting head of the dietary supplement division at FDA, Cara Welch, is a former official with the Natural Products Association, a supplement trade association. She was hired for the post by Daniel Fabricant, whose time at the FDA was sandwiched between stints at the same NPA. (He currently leads the group). And Susan Mayne, the head of the FDA’s Center for Food Safety and Applied Nutrition, which oversees the supplements division, won’t even be able to work on supplements — she has recused herself from such matters because her husband works at a drug company that makes supplements.

The FDA is also shackled by a bad law aimed at protecting supplement makers’ ability to make dubious claims about benefits. That same law requires the FDA to demonstrate a hazard to public safety before doing much of anything. The supplement industry has powerful allies in Congress, but Senators Dick Durbin (D-IL) and Richard Blumenthal (D-CT) have in past years offered legislation that would provide much needed reform.

With any luck, Attorney General Schneiderman’s work and the GNC agreement will serve as a wake-up call to the industry, to regulators, and to Members of Congress. The biggest wake-up call should be to consumers. Like Mr. Stanley’s miracle cure, most herbal supplements don’t deliver the advertised miracles even if the industry is able to prove that the herb is actually in the pills. Americans would be better off spending their billions somewhere else — like in the fruit and vegetable aisle.

Originally posted here.