FDA issues more warning letters for disease claims

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FDA issues more warning letters for disease claims
The US Food and Drug Administration (FDA) continues its surveillance of claims on dietary supplements with four new warning letters sent this week for disease claims on products.

Florida-based Alfa Vitamins Laboratories, Inc., received a letter for claims​ presented on its website and on its online store at amazon.com.

The Agency states that the claims made for many of the company’s products establish the products as drugs, “because they are intended for use in the cure, mitigation, treatment, or prevention of disease”.

The Agency also points to the use of metatags to bring consumers to the web pages through Internet searches, including metatags such as “reduce your blood pressure”, “diabetes”, “blood sugar supplement to regulate insulin”, and “anti-cancer herbs”.

Maine-based HSAC Enterprises, Inc. (dba Kare-N-Herbs)​ also received a warning letter for disease claims and testimonials on its product labels as a result of an FDA inspection in May, and a subsequent review of the company’s website in August.

“A written response was received [by the FDA] on May 15, 2012. Your response indicated that ‘medical claims and unsubstantiated claims’ would be removed from your websites within 60 days; however, we note that as of August 1, 2012 the claims had not been removed.  

“Further your response regarding your hardcopy product labeling is inadequate, as you state your intention is to exhaust existing inventory over the next 12 -18 months.”

Dragon Herbs, based in Santa Monica, CA​, received a warning letter following a review of claims made on the company’s website, dragonherbs.com, in July.

Claims included: “Excellent anti-viral functions in humans with no side effects”; “treat MRSA, when combined with Baicalin”; “normalize blood sugar and insulin levels”; as well as anti-cancer, anti-arthritic, and anti-obesity claims.

“Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are ‘new drugs’,” ​wrote the FDA.

Finally, Healing Ways of Desert Hot Springs, CA​, received a warning letter for website claims that its products, including “can kill parasites, bacteria and viruses”​.

In addition, FDA determined that the company’s facility had not been registered with FDA as required in § 415 of the Federal Food, Drug, and Cosmetic Act (the Act) , 21 U.S.C. § 350d, and our implementing regulation at 21 CFR Part 1, Subpart H.

“As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.”

Related topics: Regulation, Product claims

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