Rare FDA Warning Letter Shows Spanish Drug Claims no Match for Agency Translators

Posted 05 August 2014 By Alexander Gaffney, RAC

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A Warning Letter issued this week by the US Food and Drug Administration (FDA) to a marketer of pharmaceutical products is a rare example of FDA cracking down on promotional claims made in Spanish and aimed at an audience outside the continental US.

Background

The 30 June 2014 letter (released to the public on 5 August 2014) is based on FDA's review of a website reportedly owned by a Puerto Rican proprietor, Ramon Rosa.

The letter itself is fairly straightforward in its substance. FDA claims Rosa misbranded his products, which had not received FDA approval, as drugs in violation of the Federal Food, Drug and Cosmetic Act (FD&C Act).  The products claim to treat cancer, diabetes, high blood pressure, herpes, influenza, rashes, insomnia, boils, arthritis, ringworm, scurvy and more.

A Focus on Spanish

But substance aside, the letter is notable because Rosa's claims were made in Spanish—not English. The overwhelming majority of FDA's enforcement actions are made toward products which make unsubstantiated or false claims in English, a fact which makes sense given the agency's labeling regulations. 21 CFR 201 requires 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."

However, an explicit exception is made in the regulation for Puerto Rico, a territory of the US whose official languages are English and Spanish. For products which are solely distributed in Puerto Rico (or other territories "where the predominant language is one other than English), FDA permits the drug labeling to be substituted for the local language. 21 CFR 201.16 also permits drug labels to include Spanish versions of "certain required statements."

Different Language, Same Law

But just because a drug label (which technically includes its advertising and promotional materials, which FDA considers to be an extension of a product's label) is in another language, that doesn't mean it's held to a different set of standards.

FDA's Warning Letter takes aim at Rosa's claims about his product, providing both the original text of the claims in Spanish, as well as an English translation of the claims for the benefit of readers.

And ultimately, FDA's demands of Rosa are essentially the same as any other Warning Letter regarding improper promotional claims: Stop marketing the product immediately, and bring your product into compliance with FDA regulations immediately.

In other words, no mas, por favor.

 

FDA Warning Letter

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Categories: Drugs, Compliance, Labeling, News, US, CDER

Tags: Warning Letter, Spanish, Espanol, Promotional, Labeling, Misbranding, Puerto Rico

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