The FDA is watching too!

The FDA is watching too! Regardless of where the product is made and in what language the product is marketed in the USA, proper labeling of the product is crucial. #substantiationequalstrust, #transparencyformstrust

The Food and Drug Administration (FDA) is another US government agency that looks at products marketed in the USA. Regardless of where the product is made, what language the product is marketed in the USA, advertisers must have proper labeling listing the proper ingredients. The FDA reviews labeling of products considered as cosmetics, drugs, over the count (OTC) drugs, food, etc. When the label does not match the ingredients of the product, the FDA sends “Warning Letters” addressing the concerns of the product. Luckily, the marketer has the opportunity to rectify the situation, but if no correction is made, marketers could incur penalties. For best practices, especially if introducing new products to the US market, it is best to seek legal advise to meet the requirements of advertising law, and have products labeled properly before marketing the product. Also, it is best practice to have counsel review your advertising/marketing campaigns in English and the foreign language of the advertisement. Personally, I review campaigns in English, Spanish, French and Portuguese. I also work with reliable translators for other foreign languages. #substantiationequalstrust, #transparencyformstrust

Here is a sample of an FDA Warning Letter to a marketer who did not comply with proper product labeling:

“FDA Logo

June 12, 2018

… Cosmetic Co., Ltd.

Dear …:

The United States Food and Drug Administration (FDA) has reviewed your firm’s listing information provided for … Swab,…, and found that this information is inaccurate. You have failed to address the listing deficiencies detailed in FDA’s letters to your company on July 17, 2017, and April 9, 2018. Prompt action must be taken to correct the errors.

Section … of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and … CFR… outlines the requirements for registration and listing of drug products. [1] In accordance with these requirements, the listing for … Swab,…, must include the listed drug’s proprietary name, the name and quantity of each active ingredient contained in the drug, and a representative sample of labeling.

A review of the listing for …. Swab … reveals that the drug information in the electronic listing file does not match the drug information identified in the labeling included with the drug listing. It appears that the labeling included with the drug listing submission refers to a different product. Specifically, the product’s proprietary name of “… Swab” does not match the proprietary name, which appears on the carton label image provided with the listing file. Also, the active ingredient, “Adenosine,” identified in the “Drug Facts” section of the labeling is not included as an active ingredient in the listing file submitted. The listing file specifies “Glycerin” as the only active ingredient.

Your firm failed to fulfill its listing obligations under … the FD&C Act, which is prohibited under …. Such failure misbrands the product under … the FD&C Act, and introduction or delivery for introduction into interstate commerce of a misbranded product is prohibited ….

For your information, an Over-The-Counter (OTC) drug product can be marketed in the United States either (1) pursuant to the OTC Drug Review or (2) through a New Drug Application (NDA) for products that do not fit within a specific rulemaking. If the intent is to market your product as an OTC drug product within the scope of FDA’s OTC Drug Review, it must meet the conditions of the applicable monograph and each general condition in….

In addition, OTC drug products must comply with all the requirements … of the FD&C Act and all pertinent regulations …. For example, they must be labeled in accordance with the “Drug Facts” labeling requirements …. Dual language labeling with English and another language is permissible when labeled in accordance … and not otherwise false or misleading. Please note, … that “all words, statements, and other information required by or under authority of the act to appear on the label or labeling shall appear thereon in the English language” . . . and “if the label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the act to appear on the label shall appear thereon in the foreign language.”

Information from your firm’s registration and product listings is accessible not only to FDA, but to other interested parties, including consumers. Your product’s listing data have been removed from the FDA’s online NDC Directory and will not be available for public viewing until the corrections are made. This is an effort to maintain an accurate database, in support of FDA’s mission to protect and promote the public health….”