HEALTH

FDA issues warning on Ayurvedic medicines: some potentially harmful

BY Michael Johnsen

ROCKVILLE, Md. The Food and Drug Administration on Thursday warned consumers to use caution when deciding to use Ayurvedic medicines. Ayurvedic medicine is a traditional system of healing arts that originated in India that involves using products such as spices, herbs, vitamins, proteins, minerals and metals.

According to FDA, some preparations combine herbs with minerals and metals and are commonly sold on the Internet or in stores represented as Indian or South Asian alternatives.

“Consumers should know that Ayurvedic products are generally not reviewed or approved by the Food and Drug Administration,”  Mike Levy, director of the Division of New Drugs and Labeling Compliance in the Office of Compliance, part of FDA’s Center for Drug Evaluation and Research, said. “Consumers need to be on guard when purchasing any product using the Internet, especially medical products.”

The presence of metals in some Ayurvedic products makes them potentially harmful, the FDA noted. A study published in the Aug. 27 issue of the Journal of the American Medical Association demonstrated that one-fifth of U.S.-manufactured and Indian-manufactured Ayurvedic products bought on the Internet contained detectable lead, mercury or arsenic.

Researchers found 25 Web sites selling Ayurvedic products. After identifying 673 products, they randomly selected 230 for purchase. Of those, they received and analyzed 193 products. Nearly 21 percent were found to contain detectable levels of lead, mercury or arsenic, the agency reported.

“This issue has been and will continue to be a priority for FDA,” Levy said. In light of recent reports, FDA is re-evaluating its existing import alert and considering possible enforcement actions related to Ayurvedic products manufactured in the United States.

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Advertising council makes recommendations on Constellation Wines’ dietary claims

BY Michael Johnsen

NEW YORK The National Advertising Division of the Council of Better Business Bureaus on Tuesday determined that Constellation Wines U.S./PolyPhenolics provided reasonable support for certain performance claims made for the company’s dietary supplement MegaNatural-BP, but recommended the company discontinue certain claims to avoid consumer confusion.

NAD was concerned that that the claim “Provide relief with half the cost, half the dose,” did not clearly identify the object of the comparison and suggested that consumers with high blood pressure could replace prescribed medication with a supplement.

NAD recommended that the advertiser discontinue the claim, “Provide relief with half the cost, half the dose and half the time” but noted that the advertiser can continue to discuss the differences between MegaNatural-BP and the competing Antigen Converting Enzyme (ACE) inhibitors which take 4-6 weeks of regular supplementation to work.

NAD recommended that to avoid the potential for any consumer confusion, and consistent with the findings of the studies on which it relies, the advertiser clearly and conspicuously disclose that MegaNatural-BP could be used as a part of a lifestyle management program for people with prehypertension and metabolic syndrome, and clearly state that consumers should “Consult your doctor before taking MegaNatural-BP.” 

The company, in its advertiser’s statement, said it “understands NAD’s decision as written and appreciates your thorough and well-explained rationale.  Polyphenolics agrees to modify its advertising as recommended.”

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Congressman ask for review of Bayer aspirin heart health claims

BY Michael Johnsen

WASHINGTON Two Michigan democrats have singled out Bayer’s marketing of its Aspirin with Heart Advantage, a combination product that includes a dietary supplement, that appears to go against a Food and Drug Administration’s request not to advertise such products, said House of Representatives Energy and Commerce Chairman John Dingell, according to a Reuters report published Tuesday.

Dingell, along with Rep. Bart Stupak, fired off two letters suggesting that the supplement/analgesic combination product might need FDA approval—one to Bayer and the other to Health and Human Services secretary Michael Leavitt. HHS oversees the FDA.

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