What's in a Label? The FDA and Product Labelling…

The United States Food and Drug Administration (“FDA”) is assigned the task of keeping Americans safe by regulating the sale of food and drugs. Among many things, the FDA regulates the “labeling” of many products. Appropriate labeling is significantly important to protect the health of consumers. Additionally, the labels of a cosmetic product allow the average consumer to make informed decisions about their health and to understand the ramifications of what they are purchasing.

Now, you may be asking yourself, what is labeling? The FDA defines labeling as “all labels and other written, printed, or graphic matter on or accompanying a product.” FD&C Act, sec. 201(m); 21 U.S.C. 321(m). This means everything placed on the product itself is within the meaning of a label for FDA regulation purposes.

More importantly, the FDA requires the labeling of a product to be factual. Any product advertising false or misleading information or that fails to provide necessary information for the average consumer to make an informed decision about what they are purchasing may become misbranded under the FDA. In addition, the improper display of required information or violations of the requirements of the Poison Prevention Packaging Act of 1970 are also grounds for misbranding. Furthermore, the FDA has made it clear that “it is illegal to introduce a misbranded cosmetic into interstate commerce, and such products are subject to regulatory action.”

However, the FDA does not pre-approve cosmetic product labeling. Therefore, it is solely the responsibility of manufacturer’s and/or distributor’s to label their products accordingly. On the other hand, a manufacturer and/or distributor that fails to follow these regulations, subjects its product to misbranding.

If you need more information concerning the adequate introduction of a cosmetic product in the United States without the possibility of violating any FDA regulations in Miami-Dade, Broward, Monroe, Collier or Lee County Florida, schedule a consultation with the experienced attorneys at EPGDLaw today, located in beautiful Coral Gables. Call us at (786) 837-6787 or e-mail us to schedule a consultation.