FDA Warns Supplement Maker Over Misleading Claims

The U.S. Food and Drug Administration (FDA) just issued a warning letter to Chronicity Inc. that it must correct a number of false claims on its “NutriElements” brand supplement labels, as well as misleading claims on its Web site.

Chronicity sells services and products to consumers complaining of chronic fatigue, fibromyalgia, learning disabilities, and attention deficit disorder (ADD), said the Chicago Tribune. The warning letter, dated September 7, stated that NutriElements supplements were inappropriately marketed with “therapeutic” claims. This means, said the Tribune, that the products, which promise to “cure, mitigate, treat or prevent the disease” are, now, unapproved drugs and under the purview of the FDA.

The FDA named eight products: “Anti-Viral,” “Artesmisinin,” “Leuko-Stim,” “Chol-Less,” “Selenium 200 mcg,” “GastroHealth,” and “Omega 3,” stating that “the unlawful disease treatment and prevention claims on your website were too numerous to list in this letter,” reported the Tribune.

According to Chronicity Chief Executive Officer (CEO) Dr. Richard Vance, Chronicity is in the midst of a reorganization; the mandated changes will be made to its Web site as soon as possible. “(The FDA letter) came as a surprise to me,” said Vance, who stepped in to his CEO position this February, said the Tribune. Vance said he has responded to the agency and agrees with the changes. “We want to make sure the language on the Web site is appropriate,” he said. “(The claims) shouldn’t have been up,” Vance added, according to the Tribune.

Chronicity has begun to implement some of the changes. For instance, said the Tribune, the Leuko-Stim claim that the product “improves the ability to fight infections and decreases cancer risk” now states that “(Leuko-Stim) supports the body’s defense system when under stress,” citing a letter Chronicity wrote to the FDA.

While medications undergo safety and efficacy testing in order to receive approval by the FDA for release to market, dietary supplements do not, noted the Tribune. In the case of supplements, manufacturers must ensure safety, efficacy, and proper labeling. Also, as we’ve previously noted, supplements made from products available on the U.S. market prior to 1994 can be sold with no agency review, including a wide variety currently available. Sellers of products containing substances unavailable prior to 1994, need only advise the FDA and do not require approval to be sold.

About two-thirds of all Americans take some sort of dietary supplement and earlier this year, the FDA announced it is seeking clarification on safety rules in effect for dietary supplements, and was issuing draft guidelines meant to assist with firms’ compliance with the 1994 regulation of “new dietary ingredients in tablets, powders, liquids, and other supplements,” and mandates makers file a safety notification with the agency prior to marketing any dietary ingredient that was not on the market in 1994. Since the law’s passage, the agency said it only received about 700 such notifications, but believes over 55,000 dietary supplement products are being sold and marketed today.

We previously wrote that Consumer Reports discussed its concern with the 1994 Dietary Supplement Health and Education Act (DSHEA), which it said is industry friendly and does not enable the FDA to regulate supplements as prescription medications. Of note, the Federal Trade Commission (FCC) is the agency that regulates herbal supplement marketing, which includes a ban on claims of medical condition treatment.