FDA targets company making cancer treatment claims
territory of pharmaceuticals, the US Food & Drug Administration
(FDA) has issued a warning to Zeo Health for three of its products.
The federal agency has objected in a letter to claims on the company's website surrounding products Esdifan, Destroxin, and Zeo. The claims in question pertain to cancer, diarrhea and hangovers. Both FDA and the Federal Trade Commission (FTC) have been using their jurisdiction to weed out companies making false claims - be it on labels or in advertising - and for the dietary supplement industry this represents a credibility plug. The industry is regulated by the Dietary Supplement Health and Education Act (DSHEA), which is part of the Food and Cosmetics Act. Unlike pharmaceuticals, which must go through a series of pre-market approvals, finished dietary supplements need no pre-market approval. Instead, only ingredients not marketed in the US before October 1994 must be approved by FDA before being used in consumer products. The agency is pointing the finger at Zeo Health for not sticking to these distinctions. "FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective." stated FDA in its letter dated June 29. Unlike, pharmaceutical drugs, dietary supplements are permitted few health claims. And it is this division that has brought FDA to Zeo Health's doorstep. "The therapeutic claims on your web site establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease," wrote FDA in a letter to the New York state-based company. In its warning letter, FDA objects to Zeo Health's promotion of Destroxin for cancer prevention and treatment. The agency highlights an example of phrasing to this effect as found on the company's website: "The scientific community has recently had very positive results on the effect of Zeolite on certain types of cancers. In tests on a variety of tumor types, the treatment with Zeolite led to improvement of overall health status, prolongation of life span, and a decrease in tumor size." The insinuation that the supplement can prevent or treat cancer continues in the dosage information provided by Zeo Health: "For prevention: As a nutritional supplement, take 2 capsules twice daily. As part of Cancer therapy: As a dietary supplement, take 6 capsules three times daily." FDA also revealed that Zeo Health claims on its website that the supplement Esdifan is recommended for consumers with irritable bowel syndrome and Crohn's disease. "Esdifan is the most effective relief for diarrhea and bad stomach. Better than any drug on the market....," stated Zeo Health on its company website, according to FDA. In its website marketing, Zeo Health leapfrogs from cancer prevention to hangover cures in its product claims. The company claims that its Zeolite supplement absorbs toxins associated with alcohol before they make it into the organs: "ZEO absorbs the toxins from the alcohol before they are processed into your organs." FDA has urged Zeo Health to respond to its letter within 15 working days of receipt, advising the agency of the steps the company is taking to correct the violations. "Failure to do so may result in enforcement action without further notice."
