FDA’s labeling regulations can be some of the most confusing and detailed regulations a manufacturer or shipper ever tries to interpret.

FDAImports.com consultants and affiliated attorneys routinely provide advice and counsel regarding food and dietary supplement and cosmetic labeling requirements.

This includes providing advice about Nutritional Labeling requirements, ingredients statements, Supplement Facts, structure function claims, nutrient content claims, health claims, allergen labeling, and ingredients and additive evaluations for safety.

There is a reason why FDA focuses so heavily on product labeling requirements for imported foods, cosmetics, and dietary supplements, but it has little to do with public safety. If FDA samples an imported product but finds no violation associated with the analysis, then by regulation the agency must pay the importer, owner, or consignee the cost of sample. If, however, there is some violation, even if it is a relatively minor or insignificant labeling problem, FDA does not pay for the samples it takes. Therefore, FDA tends to find labeling violations with nearly every food, cosmetic, dietary supplement, drug, or device it examines or samples.

It is critical to ensure your product labels comply with U.S. requirements before you export your products to the United States. The design of the label can emphasize, through pictures or images, certain aspects of the product that results in the product being misbranded under the law. Type size and information location is prescribed by FDA regulation. Improper declaration of ingredients can result in FDA detentions and refusals.

Food Labeling and Nutrient Content, Structure-Function, or Health Related Claims

FDA’s labeling regulations related to conventional foods, dietary supplements, or medical foods can be quite complex. This is particularly true respecting the types of labeling or advertising claims that may be made about the product. FDA permits “nutrient content claims” certain “structure-function” claims and “qualified” (and sometimes “unqualified”) “health claims” depending upon the product, its ingredients and nutrients, its intended use, and the health benefit associated with its consumption. Such claims can increase the marketability of your products in the US market. However, if they are improperly made, FDA will detain and refuse the product.

FDAImports.com consultants and affiliated attorneys routinely review product labels and labeling to ensure compliance with FDA requirements before they are shipped and detained and refused by FDA.

For more detailed information regarding dietary supplement labeling, please see our Dietary Supplement Labeling & Claims page.

"Label" vs. "Labeling"

FDA obviously regulates the product "label"; the printed information appearing on the product or its immediate container. But many people do not realize that FDA also regulates Internet sites that are used to market their products. In addition, FDA regulates marketing and advertising of drugs and medical devices.

FDA routinely evaluates advertising, marketing and Internet sites to determine the manufacturer's or distributor's intended uses for the product. If the intended uses are broader than those that are included in an FDA approval application (in the case of drugs or devices) or that are not permitted by law or regulation, FDA will consider and often take regulatory action.

The distinction between a product's "label" and its "labeling" is most obvious in the manufacturing, packing, or distributing of dietary supplements, nutritional supplements or herbal supplements. Now a nearly 42 billion dollar industry, the vast majority of supplements on the U.S. market make labeling claims that go beyond the safe harbor protections in the Dietary Supplement Health & Education Act (DSHEA).

Even if the product's "label" contains relatively little information about the product -- because of the relatively small amount of labeling "real estate" -- its "labeling," such as inserts, brochures, and Internet sites used to market the supplement often contains (illegal) disease claims or permissible structure or function claims that are illegal only because the manufacturer, packer, or distributor never filed a structure/function notification with FDA as required.

See our FDA Enforcement News Board discussing enforcement actions against dietary supplements bearing illegal disease claims, such products that contain residues of FDA approved drug active ingredients (or analogs thereof), or distributors, marketers or manufacturers of such products.

FDAImports.com consultants and affiliated attorneys often assist clients by evaluating marketing, advertising, and Internet site claims to ensure they comply with FDA law and regulations.