HBW Insight 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

UsernamePublicRestriction
UsernamePublicRestriction

FDA Denies Petition To Classify Home Tooth Whiteners As Drugs

This article was originally published in The Rose Sheet

Executive Summary

Data in a 2009 petition submitted by the American Dental Association is insufficient to warrant a drug designation for peroxide-containing tooth-whitening products as a group, according to the agency’s April 22 response. Further information on specific product formulations, mechanisms of action and safety profiles would be required for FDA to determine whether they meet the definition of a drug under federal law, the agency says.

You may also be interested in...



P&G Defends Tooth-Whitening Cosmetic Classification In FDA Letter

Procter & Gamble urges FDA to deny a citizen petition by the American Dental Association to reclassify commercially available tooth whiteners as drugs, saying the petition is motivated by the financial interests of ADA members

Dental Association Petitions FDA To Evaluate Tooth-Whitening Treatments

The American Dental Association asks FDA to follow through on its promise to evaluate the safety of tooth-bleaching systems and classify the regulatory status of the products, which are rapidly increasing in number

‘Astonishing Results’ Or ‘Outrageous’ Claims? Peter Thomas Roth Fighting Bicoastal Class Actions

Plaintiffs against the prestige, “clinical” skin-care company are targeting anti-aging claims on its Rose Stem Cell Bio-Repair line and statements about hyaluronic acid’s ultra-moisturizing capabilities, used to market its Water Drench range. PTR faces false advertising class actions in California and New York federal courts, and the former case appears to be headed for trial.

Related Companies

UsernamePublicRestriction

Register

RS018999

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