FDA Sends Out Cyber Warning Letters

COLLEGE PARK, Md.--The Food and Drug Administration (FDA) sent seven cyber letters to online retailers of dietary supplements (that were sent late July, early August and which were only recently made public) discussing why statements made on the sites were drug claims.

Nevada City, Calif.-based Hawaiian Island Noni was sent a letter July 31 stating that its site (www.energyforlife.com) promoted conditions that caused its product Hawaiian Island Noni to be a drug under section 201 (g)(1) of the Federal Food, Drug and Cosmetic Act. Claims included "Health challenges reported to have been helped by noni [include] AIDS, allergies, stroke" and "A report from Cancer Letters claims that noni turned cancer cells back into normal cells!".

In a letter sent Aug. 1 to HEAL Marketplace in Hendersonville, N.C., FDA chastised the company for promoting products such as Herbal Anti-Depressant Formula as a natural substitute for antidepressants and Heart Tonic with red clover and garlic as being a "potent and effective heart and circulatory medication" on its site (www.shepherds-rod.org/HEAL).

Mt. View, Ark.-based Herbal Healer Academy Inc. was sent an Aug. 12 letter stating that its site (www.herbalhealer.com) promoted products such as Citricidal™ and Myomin as beneficial for cancer and cysts, respectively.

In a July 31 letter, Badger, Calif.-based Jagulana Herbal Products was cited by FDA for promoting its jiaogulan product for lowering cholesterol and treating hypertension on the company's sites (immortalityherb.com, www.jiaogulan.net).

Houston, Texas-based New Horizons received an Aug. 1 letter for promoting products like Bovine Colostrum as benefiting colds, allergies, diabetes and tumors on its site (www.behealthy.com).

Optimal Health Concepts in Camarillo, Calif., was sent a July 31 letter for promoting products such as Herp-Eeze™ for helping with chronic fatigue syndrome and herpes on its site (www.intohealth.com).

And Fort Worth, Texas-based SmartBodyz Nutrition was sent an Aug. 13 letter stating that, on its site (www.dietsexercise.com), products such as Acetyl-L-Carnitine crossed over to drug status with claims that promoted it as a means to treat neurological dysfunction and congestive heart failure.

As of Sept. 5, it appeared that only one company had changed its site's claims per FDA's request. Greg Jones, founder and president of Optimal Health Concepts, said that he received the FDA letter after getting back from his honeymoon and that it only took a few minutes to make the changes. "It is interesting, though, that you can't take information that is given to you by the manufacturers and post it online," Jones said. "Even in the FDA letter, the agency recognized that online retailers are disseminating information given to them by manufacturers, but the agency doesn't approve of it."

He added that he did not follow up with FDA after fixing the site, since the agency had not requested that in its letter. "I was thinking of calling them, but then I was like, why put a mental sticky note in their head?" he said. "It's like, `I fixed the site, now go away.'"

For copies of the letters, visit www.fda.gov/cder/warn/cyber/cyber2002.htm.