Читать книгу Food Regulation - Neal D. Fortin - Страница 301

A subcategory of health claims is drug claims. A drug claim is a claim that states or implies that a product is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.

A product with an unapproved drug claim may result in multiple violations of the FD&C Act. The most obvious potential violation is the prohibition on false or misleading claims, but this is the least of the concerns. FDA has far easier options than being drawn into a factual battle over the quality and the quantity of scientific research supporting a therapeutic claim. Specifically, FDA is more likely to bring actions for violation as follows:

 Marketing an unapproved new drug.⁶⁸

 Misbranding a drug by failing to include adequate directions for use.⁶⁹

FDA may bring both charges against a product with unapproved therapeutic claims. This is sometimes referred to as the FDA “double squeeze.”