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



Executive Summary

HOUSE OVERSIGHT HEARING ON FDA REGULATION OF HEALTH CLAIMS FOR FOOD will be held Oct. 31 in the Government Operations/Intergovernmental Relations Subcommittee, chaired by Rep. Weiss (D-N.Y.). FDA Commissioner Young is scheduled to testify. Other witnesses will be the attorneys general of New York and Iowa, Robert Abrams and Tom Miller, respectively, who "will describe how the states have attempted to fill the void left by FDA's failure to regulate health claims," according to a release by the full committee. A fourth witness will be the director of the Center for Science in the Public Interest, Bruce Silverglade. The hearing was sparked by the "proliferation" of health claims being made for foods and the agency's "refusal to take enforcement action against health claims viewed by the agency's own experts as being misleading," the committee said. The subcommittee will focus in part on a 1987 FDA proposed rule which allowed use of health claims. The subcommittee examined the food claims issue in December 1987. The following April, the committee released a report concluding that the FDA 1987 proposal violated federal food and drug laws. The subcommittee is expected to review a recent New York federal court decision denying an FDA request for seizure action against a lecithin-based food supplement, Exachol, marketed by the firm Health Club as an aid to coronary disease prevention ("The Pink Sheet" July 31, T&G-16). The decision was based on the fact that the agency had deferred regulatory action against products such as Kellogg's All Bran cereal, which made similar claims. Legislation requiring FDA regulation of health claims for foods has been introduced by Sen. Metzenbaum (D-Ohio) and Rep. Waxman (D-Calif.). Markup of the Waxman bill was completed Oct. 25 in the House Energy and Commerce/Health Subcommittee, which Waxman chairs. An amended version of the House bill, HR 3028, requires FDA to develop regulations authorizing claims when the agency "determines, based on publicly available scientific evidence (including evidence from well designed studies conducted in a manner which is consistent with generally recognized scientific procedures and principles), that there is significant scientific basis . . . regarding such a claim." The Senate Labor & Human Resources Committee is scheduled to begin marking up the Metzenbaum bill on Nov. 3.

You may also be interested in...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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