Labeling Errors Make Recalls Likely

The Food and Drug Administration (FDA) regularly monitors labels for false claims and errors, often pulling whole lots of product for which it finds a problem. Case in point: a recent nationwide recall of Encore Tablets, a dietary supplement sold in health food stores, via the internet and by mail order nationwide and in Canada.

The product was recalled because it contains potentially harmful, undeclared ingredients. According to FDA, the undeclared chemicals poses a threat to consumers because they may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.

In a similar vein, approximately $2 Million of a potentially harmful "cosmetic" eye product was recently seized by FDA. The product, a batch of 12,682 applicator tubes of Age Intervention Eyelash, may lead to decreased vision. Age Intervention Eyelash is sold and distributed by Jan Marini Skin Research, Inc., of San Jose, Calif.

FDA considers Age Intervention Eyelash to be an unapproved and misbranded drug because Jan Marini Skin Research has promoted the product to increase eyelash growth. Before any new drug product may be legally marketed, it must be shown to be safe and effective, and approved by FDA.

FDA also considers the seized Age Intervention Eyelash to be an adulterated cosmetic. The product contains bimatoprost, an active ingredient in an FDA-approved drug to treat elevated intraocular pressure (elevated pressure inside the eye).

Also in recent months, the labeling has been revised for the diabetes drug Avandia. FDA announced that the manufacturer of Avandia (rosiglitazone) has agreed to add new information about potential increased risk for heart attacks to the existing boxed warning. Avandia, which is used to treat type 2 diabetes, is manufactured by GlaxoSmithKline.

FDA is allowing Avandia to stay on the market while a new long-term study to evaluate the potential cardiovascular risk of Avandia, compared to an active control agent, is conducted by GSK. The company agreed to add new information to the drug's labeling, warning of the potential for increased risk of heart attacks.

Mislabeling has also hit the dietary supplement industry, when approximately $71,000 of dietary supplements was recently seized at FDA's request. U.S. Marshals seized the goods from FulLife Natural Options, Inc., of Boca Raton, Fla., which marketed and distributed Charantea Ampalaya Capsules and Charantea Ampalaya Tea.

Although these products were labeled as dietary supplements, they were being promoted by FulLife for use in treating serious conditions, such as diabetes, anemia, and hypertension. These claims were evident in the products' labeling, including promotional literature and FulLife's Internet Web site.

FDA considers these products to be unapproved new drugs because they make claims related to the prevention or treatment of diseases in the products' labeling.

Following an investigation of the firm's marketing practices, FDA officials advised FulLife that the claims related to prevention or treatment of diseases made these products subject to regulation as drugs. Despite FDA's warnings, the firm failed to bring its marketing into compliance with the law. During subsequent inspections, FDA inspectors found that the offending claims were still being made.

The seizure at FulLife is the second such enforcement action in two months taken by FDA against dietary supplements being promoted with drug claims to cure or treat diabetes and other diseases or conditions.

They also seized an estimated $41,000 worth of inventory of Glucobetic, Neuro-betic, Ocu-Comp, Atri-Oxi, Super-Flex, MSM-1000, and Atri-E-400 capsules being promoted and distributed by Charron Nutrition of Tallahassee, Fla., for use in treating diabetes, arthritis, and other serious health conditions.

Whether products are cosmetic, medical or herbal, the best way to avoid having product seized and losing money is to get labels and marketing materials right the first time.

Call (734) 274-4680 or email us at Ask VCI to find out how VCI can help you.

Alternatively, call Dr. Norm Howe, Sr. Partner, directly at 734.740.9924