The label of an article can bring it within the regulatory jurisdiction of the FDA in unanticipated ways. Manufacturers and distributors of foods, cosmetics and dietary supplements might find FDA treating their products as drugs or devices based upon claims made on an Internet site marketing the product.

The design of a label, or a picture or image that appears on a label, could be viewed by FDA as an implied disease claim - affecting how FDA interprets every written statement on the product's label.

FDA has been increasing its enforcement of the dietary supplement structure/function labeling regulations - and treating dietary supplement manufacturers as drug manufacturers. This ordinarily occurs because FDA has reviewed marketing materials and found implied or express disease claims in the labeling of products manufactured or distributed by the inspected firm. FDA tends to take this enforcement approach for imported dietary supplements and cosmetics alike.

For these reasons, it is critical to ensure food, dietary supplement, and cosmetic labels comply with the technical requirements of the Food Drug and Cosmetic Act as well as the product's labeling (including Internet websites, promotional material and print advertising) does not drag the product unintentionally under FDA's drug regulatory authority.

FDAImports.com consultants and attorneys regularly review food, dietary supplement, and cosmetic product labels and marketing and promotional materials and recommend necessary revisions to keep the products within appropriate regulatory categories in an effort to prevent FDA from exercising more rigorous oversight on the product or the manufacturing, distribution, or importing company.