Showing posts with label misbranded. Show all posts
Showing posts with label misbranded. Show all posts

Wednesday, May 22, 2013

FDA - Don't Represent Dietary Supplements As Foods


FDA: Dietary Supplements Can't be Marketed as Foods:

" . . . If nothing else, it is a very good reminder that you must be extremely careful making any representations about your product, not just the claims on the label," Prochnow said in an email Tuesday to the media. "Claims on websites and in other marketing and advertising can and will be used by FDA as evidence of the company's true intent to sell the product.""

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Friday, April 13, 2012

FDA Compliance & Enforcement - Inspection of Cosmetics: An Overview


FDA Compliance and Enforcement; Inspection of Cosmetics: An Overview:

"Section 704 of the Federal Food, Drug, and Cosmetic Act (FD and C Act) authorizes FDA to conduct inspections of cosmetic firms at reasonable times, in a reasonable manner, and without prior notice in order to assure compliance with the applicable laws and regulations, to determine whether cosmetics are safe and properly labeled, and to identify possible health risks and other violations of the law.

A number of factors affect how FDA determines that an inspection of a cosmetic establishment may be warranted. These factors may include--but are not limited to--the type of products, the significance of consumer or trade complaints received, the company's compliance history, FDA surveillance and compliance initiatives, and agency resources.

Some things to know about inspections: . . . "

'via Blog this'

Follow the link above to read the full FDA article.

Although there are no good manufacturing practice (GMP) regulations for cosmetics, the FDA offers a Good Manufacturing Practice Guidelines (Inspection Checklist). Failure to adhere to GMP may result in an adulterated or misbranded product.

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Monday, April 12, 2010

FDA Warning - Lipodissolve Products

The FDA has sent sent warning letters to six medical spas in the United States - and a cyber letter to a company in Brazil - for making false or misleading statements on their Web sites about drugs used in the procedure, or for otherwise misbranding lipodissolve products.

 Janet Woodcock, M.D., Director of FDA’s Center for Drug Evaluation and Research (CDER) says:
"We are concerned that these companies are misleading consumers. It is important for anyone who is considering this voluntary procedure to understand that the products used to perform lipodissolve procedures are not approved by FDA for fat removal."
The FDA website provides more information on the topic, FDA Warns About Lipodissolve Product Claims, with a downloadable pdf. 

I'm not a big fan of liposuction, let alone this approach using lipo-dissolving chemicals.

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