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Copyright 2013 Natural Standard (www.naturalstandard.com)
March 2012

Inhalable Caffeine Manufacturer Receives Warning Letter from FDA

On March 5, 2012, the U.S. Food and Drug Administration (FDA) sent a warning letter to Breathable Foods, Inc., the makers of the inhalable caffeine product, AeroShot, claiming that labeling and safety issues still remain for this product.

In the letter, the FDA notes that the label is unclear as to whether the product should be "inhaled" or "ingested". On its label, the AeroShot product contains statements such as "BREATHABLE ENERGY ANYTIME, ANYPLACE" and "PUFF IN". Furthermore, the website for AeroShot has statements such as "inhalable caffeine", "caffeine inhaler" and "airborne energy." However, other sections of the label describe Aeroshot as being "intended for ingestion" and an "ingestible food" to be swallowed.

Biologically, it is not possible for a product to be easily inhaled and ingested at the same time. In the body, a flap of tissue made of cartilage, called the epiglottis, covers the airways when a person eats or drinks. This prevents a person from choking on their food. Therefore it is not possible for a product to be easily inhaled while it is being consumed. Furthermore, according to specific sections of the Federal Food, Drug, and Cosmetic Act, dietary supplements can only be consumed. Therefore, AeroShot cannot be considered a dietary supplement if it is to be inhaled.

The FDA's letter highlights that the label is also in violation of another section of the Food, Drug, and Cosmetic Act, because it does not provide an address in the United States that can be contacted if someone experiences a serious side effect due to using the AeroShot product. Additionally, the FDA explains that the supplement's ingredients are not listed according to the standard guidelines of the Code of Federal Regulations (CFR).

In addition to labeling concerns, the FDA also points out safety concerns that remain regarding the use of AeroShot. First, since caffeine is usually consumed rather than inhaled, safety data regarding how this chemical affects the body if taken through the lungs is lacking. On the AeroShot website, Breathable Foods, Inc. claims that the product is made of powder particles that are larger than 10 microns in diameter and that "decades of research have shown that particles above 10 microns in size, if inhaled, fall out in the mouth and do not penetrate the respiratory tract."

In its letter, the FDA asks that the company provides the administration with experimental data that shows that the AeroShot powders are larger than 10 microns in diameter and also provide references that show that particles with this diameter cannot be inhaled into the lungs.

The FDA also highlights that it is unclear from the label which consumer age groups can safely use AeroShot. One statement on the product label says, "not intended for people under 12." Therefore, the FDA requests that Breathable Foods, Inc. send them information used by the company to determine that the product can be safely used by children over the age of 12 years.

Finally, the FDA points out that the AeroShot website contains news articles and news videos in which the product is used in combination with alcohol. Although these news pieces express health concerns regarding this combination, the FDA believes that by posting the news on its AeroShot website, Breathable Foods, Inc. may be marketing or publicizing AeroShot as a "party drug."

For more information about the safety of caffeine, please visit Natural Standard's Foods, Herbs & Supplements Database.

References

  1. Natural Standard: The Authority on Integrative Medicine. www.naturalstandard.com
  2. U.S. Food and Drug Administration (FDA). www.fda.gov
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