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

UsernamePublicRestriction
UsernamePublicRestriction

ESTEE LAUDER SUNSCREEN PRODUCTS ARE UNAPPROVED NEW DRUGS

Executive Summary

ESTEE LAUDER SUNSCREEN PRODUCTS ARE UNAPPROVED NEW DRUGS that are either not generally recognized as safe and effective for their labeled uses or misbranded in that their labeling fails to bear adequate directions for use, FDA Drugs & Biologics Office of Compliance Director Daniel Michels asserted in a Sept. 5 regulatory letter to the firm. The products cited by the agency include Estee Lauder Sun Golden Sun Tanning Milk, Golden Sunning Lotion, Ultra Screening Creme, Golden Sun Pre-Tanning Accelerator, Apres Tan Maintainer for Body, and Prescriptives Hand Smoother. Michels stated that the Estee Lauder products are regarded as drugs under the FD&C Act "because of statements in the labeling. . .which represent and suggest that the articles are intended for use in the prevention of sunburn or serious damage to the skin caused by sun exposure, prevention of premature aging and wrinkles, acceleration of the production of melanin, and similar claims." With regard to products that claim to help speed up the skin's production of melanin and thus contribute to greater protection from the sun, Michels declared: "We are not aware of any OTC drug product. . .with ingredients for the acceleration of the production of melanin either alone or in combination with sunscreen ingredients ultimately for the protection from the harmful effects of the sun. Neither are we aware of any substantial scientific evidence which establishes that these formulations are generally recognized as safe and effective for these uses." The agency further noted that all Estee Lauder sun products except "Golden Sun Pre-Tan Accelerator" contain the sunscreen ingredients butyl methoxydibenzoylmethane, and/or propyl methoxycinnamate, which FDA said "have not been marketed in the U.S. prior to Dec. 4, 1975 as sunscreen agents, nor to our knowledge is there any substantial scientific evidence that they are recognized as safe and effective for their intended uses." FDA also asserted that Estee Lauder may not use SPF designations higher than 15. Michels said FDA's OTC advisory review panel "made no recommendation for an SPF number higher than 15 to appear in the labeling of sunscreen drug products." Estee Lauder products bear designations of SPF 23 and SPF 19.

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

UsernamePublicRestriction

Register

LL1129949

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

Cancel