Risk

Risk Management greatly reduces inefficiencies resulting from unanticipated operational disruptions.

read more

Compliance

For regulated organizations, quality problems & non-compliance have serious consequences

read more

Quality

An integrated and effective quality system is key to improve efficiency & compliance in manufacturing operations.

read more

.
Analysis of a Warning Letter

Analysis of a Warning Letter

Mark Crawford

What a difference some wording makes!

On March 6, the U.S. Food and Drug Administration issued a warning letter to Breathable Foods Inc. for false or misleading statements regarding its product AeroShot. It was told this “caffeine inhaler” could pose risk to children and adolescents and in combination with alcohol.

The company states AeroShot provides “breathable energy, anytime, anyplace.” On the website it states the product is intended to be ingested by swallowing. The FDA maintains this labeling is false or misleading because these two claims contradict each other. This could also have major implications as to whether the product is categorized as a dietary supplement or a drug.

FDA is concerned that by calling it “breathable energy” consumers may try to inhale AeroShot directly into their lungs. “Caffeine is not normally inhaled into the lungs and the safety of doing so has not been well studied,” states the FDA. Breathable Foods maintains the particles in AeroShot are too big to enter the lungs, yet does not provide research to support this claim.  

The website indicates that AeroShot is “not recommended for those under 18 years of age,” yet the product label states that it is “not intended for people under 12.” This suggests to the FDA “that the product is suitable for children 12 and over. Please provide us with any safety evidence you have relied upon related to the use of your product by children and adolescents so that we can evaluate that evidence.”

Because it is sold as a dietary supplement AeroShot did not require FDA review and approval. However, New York’s U.S. Sen. Charles Schumer met with FDA Commissioner Dr. Margaret Hamburg, who agreed to review the safety and legality of AeroShot.

“I am worried how a product like this impacts kids and teens, who are particularly vulnerable to overusing a product that allows one to take hit after hit after hit, in rapid succession,” Schumer says.

So is AeroShot a supplement or a drug?

According to Neal Fortin, Professor and Director of the Michigan State University Institute for Food Laws and Regulations, who also writes the Food Law Blog (www.foodlawblog.foodlaw.org), states that by definition, according to the FDA, “dietary supplements must be intended for ingestion” and that “a product intended for inhalation is not a dietary supplement.”

“Surprisingly,” says Fortin, “the FDA did not state the consequence of failing to be a dietary supplement—as far as it is intended for caffeine inhalation, Aeroshot would be a drug and medical device.” 

Therefore it would seem the actual size of the molecules of the ingredients in AeroShot is critical to this determination. If the particles are small enough to be inhaled through the lungs, then conflicting information exists about safety and usage that could result in the product being ruled as a drug.

Ultimately the take-away message is to be absolutely certain that, in the rush to get to market, your marketing labels and usage labels tell exactly same story and have all the information required by the FDA; why risk everything you have gained by sloppy marketing so late in the game?

 

Share

Tags: , , , ,

Leave a Reply

Pilgrim Software News

    Archives