Labeling drug products misbranding

If a USP monograph exists for a drug product, the product is subject to USP standards whether the product bears the USP symbols after the name or not. If a product differs from existing USP standards (strength, quahty, purity) the label must state Not USP If it is not stated as Not USP then the product would be deemed misbranded or adulterated. 

If a pharmacist posted a sign in a pharmacy claiming a dietary supplement is effective in treating or preventing a certain disease, the pharmacist would be violating the FDCA. The product would be considered a drug but not properly labeled as a drug and therefore would be misbranded. 

The harmonization activity should further the FDA s mission to protect the public health by, among other things, ensuring that food is safe and otherwise not adulterated or misbranded that human and veterinary drugs, human biological products, and medical devices are safe and effective as required by law and are not adulterated or misbranded that cosmetics are not adulterated or misbranded that electronic product radiation is properly controlled and that all of these products are labeled truthfully and informatively. 

Pure Food and Drug Law Adulteration and misbranding of food and drugs a) FDA reviews food and drug labels b) FDA can seize or withdraw improperly labeled products from the market... 

In the United States, the Food Drug and Cosmetics Act (FDCA) also creates statutory offences for certain actions or inactions. For example, it is not permissible to sell a misbranded drug or device, or one with labeling that is false, misleading or fails to bear adequate directions for use. In addition, an adulterated product may not be introduced, such as one that has been modified from its intended use. 

The Food, Drug, and Cosmetic Act of 1938 provided definitions for cosmetics and drugs and prohibited interstate commerce for cosmetics that are adultered or misbranded. By definition, adultered means that the product contains a poisonous or deleterious substance, a nonpermitted color additive, or a filthy, putrid, or decomposed substance or that it was manufactured or held under nonsanitary conditions. Misbranded means that it contains false labeling, does not contain the required labeling, or is not truthfully packaged. 

In 1989, psyllium was introduced into processed foods, including General Foods Benefits cereal and Kellogg s Heartwise cereal, with claims for cholesterol-reducing benefits and soluble fiber health benefits. Shortly after introduction, the FDA suggested the products were misbranded drugs due to insufficient evidence to support the labeling claims. Benefits was removed from the market, while Heartwise is still marketed. 

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