Category Archives: Cosmetics

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FDA on UGC

A recent warning letter suggests that FDA, in regulating user generated content (“UGC”) on social media pages, will likely treat all companies the same. Earlier this year, FDA released two guidance documents for drug and medical device companies on social media. Those documents provided the following stance on UGC: “[A] firm generally is not responsible for UGC … Continue Reading

FDA Reopens Comment Period on Final Guidance Requiring INDs for Certain Food, Dietary Supplement, and Cosmetic Studies

The FDA today published a Federal Register notice reopening the comment period on the Final Guidance entitled “Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can be Conducted Without an IND.” FDA published the IND guidance document in draft form in October 2010. FDA then released a significantly expanded version of the … Continue Reading

FDA Proposes New User Fees to Finance Food & Cosmetic Safety

On April 10, 2013, the U.S. Food and Drug Administration (“FDA”) announced a proposal that could increase the cost of doing business for the food and cosmetic industry. In its budget request for fiscal year 2014, the FDA has proposed two new user fee programs for food companies to help pay for implementation of the … Continue Reading

Heightened FDA Activity Related to OTC Drugs Expected in 2013

According to the 2013 unified agenda for the Department of Health and Human Services, FDA plans to recommend several changes to U.S. OTC drug labeling, safety monitoring, and manufacturing standards in 2013 which may impact future marketing and product development strategies for consumer products. Forthcoming FDA proposals include the following:  Proposed Monograph Modifications  Amending the … Continue Reading

California Federal Court Denies Federal Preemption for Cosmetics Labeled as Organic

A recent decision in the U.S. District Court of the Northern District of California, Brown v. Hain Celestial Group, Inc., provides important insights into cosmetic and food product organic claims. In 2011, a complaint filed against a cosmetic company alleged that the company’s organic claims violated the California Organic Products Act of 2003 (“COPA”). COPA … Continue Reading

Congressional Committee Considers “Modernizing” FDA Authority over Cosmetics

On March 27, 2012, the House Energy and Commerce Committee held a hearing entitled “Examining the Current State of Cosmetics,” which considered existing FDA authority over cosmetics and calls to modernize that authority to address technological advances and globalization of the cosmetics industry. The hearing provided regulators and stakeholders an opportunity to voice their perspective … Continue Reading

Where in the World is FDA? FDA Submits Report to Congress on Foreign Programs as Required by FSMA

The Food and Drug Administration (“FDA”) has submitted its Report to Congress on the FDA Foreign Offices. Under the Food Safety Modernization Act (FSMA), FDA is required to update Congress on the agency’s progress in establishing foreign posts and working with foreign government counterparts to further FDA’s mission. Companies that import food, drugs, devices or … Continue Reading

FDA’s Scrutiny of Personal Care Products in 2011

It is often said that “beauty lies in the eye of the beholder.” A review of Food & Drug Administration (FDA) enforcement activity in 2011 reinforces how personal care products are beheld by FDA. A new article published by HAPPI — the Household and Personal Products Industry magazine — highlights important regulatory considerations for personal … Continue Reading

Recent FDA Testing Shows Lead in Lipsticks, Agency Maintains Levels are Safe

Recent Food and Drug Administration (FDA) test results show that detectible amounts of lead continue to be found in lipstick, but do not present a safety risk to product consumers. According to the recent FDA test data, lead levels in some products have risen since FDA initiated its testing program in 2007. Reports of lead … Continue Reading

FDA Holds Public Meeting on Cosmetic Microbiological Safety Issues to Consider Need for New Guidelines

On November 30, 2011, the Food and Drug Administration (FDA) held a public meeting to consider the need to amend pre-existing guidelines or adopt new ones addressing microbiological safety in cosmetics. The FDA presented the meeting as an opportunity for industry and other stakeholders to provide input on whether current guidelines sufficed to address cosmetic … Continue Reading

FDA Notice Clarifies Past Federal Preemption Policy Statements

The Food and Drug Administration (“FDA”) recently completed an evaluation of the legal basis for federal preemption policy statements the agency has issued under the Federal Food, Drug & Cosmetic Act (“FDCA”) during the past 10 years. FDA initiated the review in response to a memorandum issued by President Obama in May 2009 which directed … Continue Reading

Non-Profit Sues 34 Sellers of “Organic” Cosmetics

Last week, the Center for Environmental Health, a non-profit organization, filed a complaint in California Superior Court alleging that 34 cosmetics companies violated the California Organic Products Act of 2003 (“COPA”) by selling, labeling, or marketing cosmetic products containing less than 70% organic ingredients as “organic.” The Center seeks an order enjoining the defendants from … Continue Reading

Can We Say That? A Practical Guide to Substantiating Claims for Food and Consumer Health Products

This Monograph, published by the Food and Drug Law Institute, is designed to assist lawyers, regulatory advisors and marketing professionals answer the question "Can we say that?" as they design and execute programs to promote consumer health products such as foods, dietary supplements, non-prescription drugs and medical devices, cosmetics and pet care products. It serves … Continue Reading
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