Pink Sheet is part of the Informa Intelligence Division 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

UsernamePublicRestriction
UsernamePublicRestriction

REP. WYDEN WORKING TO DISLODGE FINAL REGS ON OTC WEIGHT LOSS

Executive Summary

REP. WYDEN WORKING TO DISLODGE FINAL REGS ON OTC WEIGHT LOSS products, staffers to the Oregon Democrat said March 26 following a hearing of the House Small Business/Regulation, Business Opportunity and Energy Subcommittee. Staffers said FDA will be called to a future hearing planned for late April or early May by the panel, which Rep. Wyden chairs, to discuss the status of those regulations. The regulations would help the government police the $33 bil. a year diet industry which, according to Wyden, currently is plagued with false advertising and claims that may be injurious to consumers. "While potions and weight-losing nostrums have been around for generations, our research indicates that a new mix of questionable products, untrained providers and deceptive advertising is exposing our citizens to unexpected health risks," Wyden said in his opening statement. A subcommittee staff memo released at the hearing said FDA began drafting regulations on OTC weight loss products in 1970. "In 1982, that monograph was published for comment," the memo says. "Eight years later, that monograph sits, unimplemented, in the bowels of FDA's bureaucracy." FDA staffers, contacted after the hearing, said that the regulations have been "tied up" while the agency collects additional information on products to be affected by the rules. Specifically, the agency is awaiting the results of manufacturer studies on phenylpropanolamine, a decongestant that also suppresses appetite, and benzocaine, a product used in diet aid chewing gums to anesthetize taste buds. The studies are being completed and the regulations may be published by the end of the year, the spokesman said. Accusing FDA of "sitting on the sidelines" in the regulation of OTC diet products, the subcommittee staff memo continues: "False labeling is at the heart of many of the FDA's fraud cases. Unfortunately, since most of the deception appears in pamphlets, brochures, books, lectures and the mass media -- not on the labels themselves -- many bogus products simply slip through the cracks." The document uses as an example "grapefruit pills" advertised to "give faster weight loss." * "It looks like a drug, it's marketed like a drug, but the FDA considers it a food product -- and one that's correctly labeled at that," the memo says. "Few if any of these diet gadgets, drugs or foods have been tested for safety and effectiveness before patients and consumers become unsuspecting guinea pigs." The hearing was a continuation of the subcommittee's three-year inquiry into health care industries, Wyden said. Testimony was heard from consumers whose family members were injured by diet products and from Janet Steiger, chairperson of the Federal Trade Commission, the agency responsible for enforcing truth in advertising laws. Wyden said that in recent years the agency has been encouraging competition in the health care area by allowing medical advertising but has not taken steps to protect consumers from false claims. "Had the FTC maintained an active consumer protection component to its policy of competition, consumers could well have been served by the agency's policies," the staff paper says. "But our record shows that competition without protection from hucksters and their bag of tricks leads to consumer exploitation and public health risks." Steiger said the agency is looking at medical advertising, but noted it lacks the resources to examine all potential cases. "We're moving on as many fronts as our resources will allow," she said. FTC pursues cases involving "severe consumer injury" but often lacks personnel and funding to investigate less obvious abuses of advertising laws, Steiger said. She added that enforcement of many of the fraudulent activities in this area should occur at the state and local levels through local medical boards, state attorneys and law enforcement agencies.
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS017208

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

Cancel