‘Drank’ spanked by FDA over melatonin content

By Shane Starling

- Last updated on GMT

Related tags Chief executive officer Food Food and drug administration

The Food and Drug Administration has told a Texas start-up its melatonin-containing beverage breaches the Federal Food, Drug, and Cosmetic Act because the nutrient associated with promoting sleep is not approved as a food additive.

“We are not aware of any basis to conclude that melatonin is GRAS [generally recognized as safe] for use in conventional foods,”​ the FDA wrote in its letter to Innovative Beverage Group chief executive officer, Peter Bianchi.

The company has 15 days to either provide evidence backing the product’s safety or remove it from the market in its current form.

In its letter, FDA highlighted numerous studies and a monograph which referenced certain safety concerns in regard to melatonin.

“Various credible sources and reports in the scientific literature… describe information on melatonin that would raise safety concerns about its use as a food ingredient,”​ FDA wrote.

These concerns – usually in medical use of melanonin – included the potential to increase spontaneous malignant tumor incidence in female mice; loss of photoreceptor cells in aging retinas if significant exposure to sunlight is factored in; drops in blood pressure; increases in atherosclerotic plaque buildup; hyperglycemia in patients with type-1 diabetes; gynecomastia in men; decreased sperm count and motility.

The monograph said children and pregnant women should avoid melatonin.

“You should take prompt action to correct this violation and prevent its future recurrence,” FDA said. “Failure to do so may result in enforcement action without further notice.”

FDA added: “The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products. We want you to be aware that FDA did not conduct an all inclusive review of the labeling or ingredients for your product ‘Drank’ or other products you manufacture or distribute. It is the responsibility of a manufacturer to ensure that foods the firm markets are safe and otherwise in compliance with all applicable legal and regulatory requirements.”

In Europe, the European Food Safety Authority last week issued an opinion that affirmed melatonin’s ability to reduce the effects of jetlag but did not support its proposed sleep benefits.

That opinion can be found here.

Related topics Regulation Cognitive function Energy

Related news

Related products

show more

Formulate for women’s health – formulate empowerment

Formulate for women’s health – formulate empowerment

Content provided by Verdure Sciences | 26-Mar-2024 | Product Brochure

Women’s health trends are mirroring bigger conversations of empowerment and wellbeing. Within the women’s health category, upticks in areas of lean muscle...

Go Beyond the Ordinary: Cognitive Health-BacoMind

Go Beyond the Ordinary: Cognitive Health-BacoMind

Content provided by Natural Remedies Private Limited | 27-Feb-2024 | White Paper

Experience the potency of BacoMind®, the #1 branded bacopa with 9 key bioactives for unparalleled cognitive support.

Nootropics Report 2.0: Brain Health Insights

Nootropics Report 2.0: Brain Health Insights

Content provided by dsm-firmenich | 22-Feb-2024 | Insight Guide

The brain health market is constantly growing and evolving, with more consumers looking for innovative ways to support total mind and body wellness.

Related suppliers

Follow us

Products

View more

Webinars