FDA issues warning letter to AeroShot maker
WASHINGTON — The maker of a breathable caffeine product has received a warning letter from the Food and Drug Administration.
In its letter, the regulatory agency said that Breathable Foods’ AeroShot product contained false or misleading statements on its labeling. The FDA also said it is concerned about the use of the product by children and adolescents, as well as the general safety of using the "caffeine inhaler." The FDA also noted that the product label does not include contact information for consumers to report any adverse events to the company, as required under federal law.
Click here to view the full warning letter.
The warning follows concern expressed by Sen. Charles Schumer, D-N.Y., who last month called on the FDA to conduct a full review of the safety and legality of the product and also questioned whether or not the product is legally marketed as a dietary supplement.
The company has 15 business days to respond to the agency with a plan to bring the product into compliance with FDA regulations.
NPA announces 800th Natural Seal certification
WASHINGTON — The Natural Products Association is celebrating the 800th certification of products and ingredients under the organization’s Natural Seal program.
"In almost four years, NPA has certified more than 800 products and ingredients under the Natural Seal. More and more consumers are using the Natural Seal to find natural products at their favorite stores," NPA president Jeff Wright said. "We’re pleased that the industry is increasingly rallying to Natural Seal certification. Retailers, manufacturers and suppliers can be confident that a product with the Natural Seal will stand out for consumers."
According to the NPA, 607 products and 247 ingredients have been certified natural via the program, and more than 85,000 stores carry products with the Natural Seal.
Homeostasis brings new line of homeopathic cough-cold items to retail pharmacy
LAS VEGAS — Homeostasis Labs featured a line of homeopathic solutions for both adults and children at the ECRM Cough & Cold and Allergy EPPS.
Specifically in the cough-cold space, Greenwich, Conn.-based Homeostasis fields three adult cough-cold products — allergy, cough and cold, and flu, along with one pediatric product: children’s Homeostasis cough and cold.
According to company officials, the brand had been successfully test marketed across one major retailer and will be fully available beginning in April.
Homeostasis is coming into the mass channel with a pre-existing social media presence on Facebook where the company relays its "green" heritage. All packaging is produced utilizing 100% renewable energy (wind power).
The full line consists of 10 adult SKUs and four children products.