FDA Says No, Puff Not a Supplement

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

Sandy Almendarez, VP of Content

March 7, 2012

2 Min Read
FDA Says No, Puff Not a Supplement

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.

About the Author(s)

Sandy Almendarez

VP of Content, Informa


• Well-known subject matter expert within the health & nutrition industry with more than 15 years’ experience reporting on natural products.

• She cares a lot about how healthy products are made, where their ingredients are sourced and how they affect human health.

• She knows that it’s the people behind the businesses — their motivations, feelings and emotions — drive industry growth, so that’s where she looks for content opportunities.

Sandy Almendarez is VP of Content for SupplySide and an award-winning journalist. She oversees the editorial and content marketing teams for the B2B media brands Natural Products Insider and Food and Beverage Insider, the education programming for the health and nutrition trade shows SupplySide East and SupplySide West, and community engagement across the SupplySide portfolio. She is a seasoned content strategist with a passion for health, good nutrition, sustainability and inclusion. With over 15 years of experience in the health and nutrition industry, Sandy brings a wealth of knowledge to her role as a content-focused business leader. With specialization in topics ranging from product development to content engagement, creative marketing and c-suite decision making, her work is known for its engaging style and its relevance for business leaders in the health and nutrition industry.

In her free time, Sandy loves running, drinking hot tea and watching her two kids grow up. She brews her own “Sandbucha” homemade kombucha; she’s happy to share if you’re ever in Phoenix!


Speaker credentials

Resides in

  • Phoenix, AZ


  • Arizona State University


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