Medical Foods

Continued from Yesterday

Lemieux also noted the unchanging nature of FDA’s regulation, but added FDA may be getting more active. “The regulation in the United States has been the same since 1988, and will not change soon, meaning that ‘medical food’ will remain as a classification. FDA and FTC are, however, a bit more cautious, as translated in warning letters.”

Indeed, warning letters are increasing, and Lemieux said FDA is generally targeting labeling and use of testimonials in its citations. With little regulatory action in the 1990s, FDA has sent at least six warning letters since 2003. In these letters, FDA charges certain companies misbranded products labeled as medical foods because they bore claims relating to diseases and conditions that lacked distinct nutritional requirements, and that the products had no unique impact on the disease. Thus, FDA concluded the products were unapproved drugs. In one 2009 letter, FDA claimed one medical-food product did not meet the definition because the nutrient requirements for the intended population could be met through modification of a normal diet, making the product unnecessary.

Another sticky situation in the medical-foods category is where to market the products. Medical foods must be labeled for use under medical supervision, and this statement must be placed prominently on packaging. However, this does not mean a prescription is required to obtain a medical food. These products can be sold over-the-counter (OTC) in food and drug stores, or as prescription products in medical clinics. Historically, a medical-food manufacturer will choose one marketing outlet and stick to it. Metagenics and PamLab, for instance, both market their medical-food products exclusively through health-care providers and pharmacies.

Continued Tomorrow

http://www.naturalproductsinsider.com/articles/2010/10/medical-foods-between-a-rock-and-a-hard-place.aspx

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http://back2basicnutrition.com/

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