Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Beverage or supplement?

This article was originally published in The Tan Sheet

Executive Summary

FDA is uncertain whether Shannon Mineral's Coolwater Trim containing SuperCitriMax (garcinia cambogia) is a dietary supplement because it is "in a liquid form with a serving size comparable to that of an ordinary beverage," the Center for Food Safety & Applied Nutrition writes in response to a 75-day premarket notification filed by the Irish marketer. While differentiation between supplements and foods is not a new concern for FDA, the explicit reference to serving size may be a sign that the agency is considering using a product's serving size to help determine whether it is a supplement or conventional food, according to attorney Marc Ullman of Ullman, Shapiro & Ullman. Botanical ingredients in products meeting the definition of a conventional food must either be generally recognized as safe for food at the added dosage or approved by FDA through the food additive process. Both Ullman and the Council for Responsible Nutrition note the letter is not a warning but a reply to an "unusual" new dietary ingredient notification...

You may also be interested in...

The Good, The Bad And The Ugly Of COVID-19 Vaccine Manufacturing Technology Platforms

Not all technology platforms provide the expected benefit of filling in CMC review gaps and speeding coronavirus vaccine approvals.

SparingVision Raises €44.5m For Mutation-Agnostic Eye Gene Therapy

A long-term, patient-centric group of investors is backing SparingVision's bid to develop a gene therapy treatment for retinitis pigmentosa that could be effective regardless of mutation.

P&G Health, Hygiene Brands Ride Consumer ‘Trust’ To Sales Growth Amid Pandemic Uncertainty

“There’s a heightened need for products that deliver against health, hygiene and clean home concerns and a willingness to spend just a little bit more to ensure that I’m using a product that I know and trust,” says CFO Jon Moeller 





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts