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


FDA letters track liquid supplement guidance

This article was originally published in The Tan Sheet

Executive Summary

Courtesy letters FDA's Division of Dietary Supplement Programs sent in 2010 appear to follow the agency's 2009 draft guidance on distinguishing liquid supplements from conventional foods (1"The Tan Sheet" Aug. 16, 2010). An April 22 2letter to Tahitian Noni International, posted on FDA's docket Aug. 24, says the Provo, Utah, firm's Tahitian Noni Original Bioactive Beverage products cannot make structure/function claims as long as they are promoted as beverages. A February 3letter to Next Generation Beverages of Hoboken, N.J., and a January 4letter to Nada Beverage Co. of Powder Springs, Ga., similarly preclude the firms' beverage products from making supplement claims. The letters are in response to the companies' notifications of supplement claims

You may also be interested in...

Supplement Firms Must Calculate Risk From Claims To Survive - Attorneys

Dietary supplement and functional food marketers should be cautious with health claims and ingredient safety if they want to avoid government scrutiny and remain profitable, according to a pair of food and drug attorneys

Long Hot Summer For Novel Drug Reviews Forecast At US FDA

Submission surge in late 2019 means a spike in late summer 2020 user fee goals, including 16 novel agents in August alone.

Keeping Track: Approvals For Tazverik And Tepezza, Priority Reviews For Belantamab Mafodotin And Lynparza

The latest drug development news and highlights from our US FDA Performance Tracker.





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