What’s in a Label? The FDA and Product Labeling…

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.

EPGD Business Law is located in beautiful Coral Gables, West Palm Beach and historic Washington D.C. Call us at (786) 837-6787, or contact us through the website to schedule a consultation.

*Disclaimer: this blog post is not intended to be legal advice. We highly recommend speaking to an attorney if you have any legal concerns. Contacting us through our website does not establish an attorney-client relationship.*

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Eric Gros-Dubois

Eric P. Gros-Dubois founded EPGD Business Law in 2013 and is the current head of the firm’s corporate, estate planning, and tax practice, and manages the firm’s Washington D.C. office. With a JD and MBA, and a specialization in finance, Eric is able to step back and view the legal world through a commercial lens while also acting as a trusted business advisor for his clients. He does his best to be solutions oriented, and tries to think like a business owner, not just a lawyer.


*The following comments are not intended to be treated as legal advice. The answer to your question is limited to the basic facts presented. Additional details may heavily alter our assessment and change the answer provided. For a more thorough review of your question please contact our office for a consultation.



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