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


Great American Products warning letter

This article was originally published in The Tan Sheet

Executive Summary

Twenty dietary supplements marketed by Great American Products may be unapproved new drugs because of labeling claims that violate the FD&C Act, FDA says in an April 18 warning letter. Statements cited by the agency that appear in internet advertising and the company catalog claim Prostate Assist is "effective in helping to reduce the risk of prostate cancer," Cholesterol Assist "has the ingredients that have been known to lower cholesterol levels" and Ultimate Glucose Advantage is "designed to effectively help reduce your glucose levels - a crucial function for those people with diabetes." Claims for the firm's Ultimate HGH product were referred to FTC by the Electronic Retailing Self-Regulation Program in September (1"The Tan Sheet" Sept. 20, 2004, In Brief)...

You may also be interested in...

ERSP referral

Claims for Great American Products' Ultimate HGH were referred to the Federal Trade Commission after the firm said it would not participate for "confidential reasons," ERSP announces Sept. 13. Claims from a 30-minute infomercial that initiated the case include statements that the product could "reverse the aging process," remove wrinkles and improve vision...

US FDA Races To List Essential Medicines For Domestic Manufacture By White House Deadline

With list due 4 November, there may not be time for public comment. Meanwhile, where will biopharma find fill/finish capacity?

ESMO: Pfizer's Lorbrena Makes Case To Claim ALK+ Lung Cancer CROWN

Lorbrena is approved as a second-line treatment for ALK-positive NSCLC but Pfizer believes data from the first-line Phase III CROWN study makes the drug a serious competitor to standard of care Alecensa in the first-line setting.





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