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Global Evolutions

FDA Says No, Puff Not a Supplement

<p>Last week, I asked if a supplement that came out in &quot;puff&quot; and was called &quot;breathable&quot; could fall under the legal term of &quot;supplement.&quot; This week, FDA's answer came in the form of a warning letter.</p>

Last week, I questioned if Breathable Foods Inc.'s new AeroShot product was a supplement or a drug because some of the marketing suggested the product is inhaled rather than ingested. AeroShot came to my attention because FDA agreed to review the product after Sen. Charles Schumer (D-NY) requested the agency investigate it. Sen. Schumer was most concerned with the product's safety for adolescents, especially if it was combined with alcohol.

Yesterday, FDA published a warning letter it sent to Breathable Foods, the company that markets the energy supplement that is dispersed in "puffs". FDA said the product raised both marketing and safety issues, and the agency's complaints went beyond the issues both Sen. Schumer and I raised.

Like me, FDA thought the directions for use were confusing to consumers with some marketing indicating the product should be inhaled, with other messages saying it intended to be swallowed. FDA said these contradictory statements could lead to safety issues if consumers try to inhale the product; the agency said inhaling caffeine has not been studies well enough to show it is safe.

Like Schumer, FDA was concerned that younger consumers would take the supplement unsafely, possibly mixing it with alcohol. Marketing from Breathable Foods said the product was not intended for children under 12, and in different messages, children under 18. FDA asked the company for research to back this restriction, showing it is safe for those 12 and younger. Further, FDA said the company's website links to news articles that mention mixing the product with alcohol or using it as a "party drug." The agency said including this material on a site that sells the product is akin to promoting the use of alcohol combined with AeroShots, which raises safety issues.

Beyond that, FDA warned the company that it needed to include contact information on its label so consumers could report adverse events if necessary.

This warning letter shows FDA is not tolerant to unclear, cleaver marketing. Companies need to be clear on how products are used and need to stick with that direction for use in all marketing. If not, we'll all read about it in FDA's next batch of warning letters.

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