Industry Hit With FDA Warning Letters

Industry Hit With FDA Warning Letters

WASHINGTON--The Food and Drug Administration (FDA) hit severaldietary supplement companies in July and August with warnings that theirproducts were not in compliance with federal regulations. The letters, whichwere made public only recently, were either mailed or e-mailed.

In a letter dated Aug. 12, FDA (www.fda.gov)reported Shakopee, Minn.-based Conklin Co. Inc. was marketing products thateither could be classified as new drugs or did not bear the mandatorySupplements Facts panel required under Title 21 of the Code of FederalRegulations. After multiple FDA visits between April and July 2002, the agencyfound the company's Life Track^TMArthritis & Joint Support and Cold Season Formula to fall under new drugstatus because both suggested they could cure, mitigate, treat or preventdisease.

In a letter dated Aug. 9, NatureMost of New England Inc. (dba NatureMostLaboratories Inc. and Trigo Laboratories Inc.) in Middletown, Conn., was citedfor mislabeling its Calm Focus product. The Food and Drug Administration (FDA)inspected the firm June 3 and 6, 2002, and found the product's labeling to be in"serious violation" of the Federal Food, Drug and Cosmetic Act.

Violations included wording on the product's brochure stating Calm Focushelped children with attention deficit hyperactivity disorder (ADHD) and thatingredients such as lecithin and rosemary protected against cardiovasculardisease and bacteria, respectively. The letter stated that, as labeled, theproduct is a new drug. Better Way Kids, in Cranston, R.I., also received aletter regarding the same product.

"You can knock heads against FDA or you can be in compliance with theirregulations," said Robert Trigo, president of NatureMost. "We wouldrather be in compliance with them." He added that the concerns FDA had werecleared up as soon as the company received the letter.

FDA also sent an Aug. 16 letter to Phoenix-based ThermoLife International, inwhich the department stated the company's Lipodryl II, which included thesynthetic compound 1R, 2a norephedrine HCl, was a drug.

All companies had 15 working days from receipt of these letters to notify FDAregarding what steps had been taken to correct the stated violations.

"The letters were pretty clear cut," said Marc Ullman of NewYork-based law firm Ullman, Shapiro & Ullman. "If you have beenlistening to what the National Nutritional Foods Association and the AmericanHerbal Products Association have been saying, this is what everyone in theindustry has been asking for from FDA: come out and do enforcement and give usguidance."

He added that ignoring a warning letter is always a bad idea, even if acompany disagrees with everything in it.

FDA also sent seven "cyber" letters to online retailers of dietarysupplements discussing why statements made on the sites were drug claims.

Nevada City, Calif.-based Hawaiian Island Noni was sent a letter July 31stating that its site (www.energyforlife.com)promoted conditions that caused its product Hawaiian Island Noni to be a drugunder section 201 (g)(1) of the Federal Food, Drug and Cosmetic Act.

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

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

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

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

Optimal Health Concepts in Camarillo, Calif., was sent a July 31 letter forpromoting products such as Herp-Eeze^TMfor 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 letterstating that, on its site (www.dietsexercise.com),products such as Acetyl-L-Carnitine crossed over to drug status with claims thatpromoted it as a means to treat neurological dysfunction and congestive heartfailure.

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

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