Vitamin Vapor Ad Claims Review Douses FDA's Dietary Supplement Definition
This article was originally published in The Rose Sheet
Executive Summary
The first review of ad claims for a vitamin vapor device by a Council of Better Business Bureaus investigative unit comes as marketing of the products is proliferating and with FDA stating that "a vitamin product for inhalation cannot be legally marketed as a dietary supplement" in the US.
You may also be interested in...
Sparq's Vitamin Vapor Inhalation Product Could Spark Regulatory Interest
Vitamin Air is so novel, it could get FDA's attention for misbranding as a supplement and being an unapproved new drug. Sparq says it's not an electronic cigarette because there's no nicotine in formulations it offers in products that resemble early-edition e-cigarettes. But it is a dietary supplement because each one is a mixture of vitamins, minerals and supplements plus natural flavors and glycerin so the formulations heat into vapor that is inhaled, the firm says.
FDA Helps E-Cigarettes Navigate NDA Process With Nonclinical Tests Guidance
Commissioner Gottlieb highlights the first of two draft guidances US FDA will publish on developing "novel, inhaled nicotine replacement therapies that could be submitted to the FDA for approval as new drugs, similar to current" OTC nicotine replacement therapies. FDA has had a contentious history with manufacturers of electronic nicotine devices, but officials have said the products are eligible for review as NRTs through the NDA process.
Another Advertising Review For Goli Nutrition: Church & Dwight Challenges Ashwagandha Claims
NAD review of Goli claims, looking at weight loss, physical performance, sexual function and sales claims, recommended it modify advertising to avoid conveying implied product efficacy claims for Ashwagandha Gummies and modify or discontinue qualified physical performance claim about ingredient KSM-66.