As we predicted earlier this year, Congress is making moves toward enacting cosmetics reform legislation in the near future. In late October 2017, Senator Orrin Hatch (R-UT) introduced S. 2003, the “FDA Cosmetic Safety and Modernization Act,” which we will refer to as the “Hatch bill” for purposes of this post.

The proposed legislation would amend the Federal Food, Drug, and Cosmetic Act by introducing measures to regulate ingredients, monitor adverse reactions to cosmetics, and establish good manufacturing practices. Under the Hatch bill, FDA would receive authority to accredit third-party organizations in order to determine chemical safety. The Hatch bill also would preempt any state action on cosmetic chemical ingredients once FDA identifies a chemical for review. We summarize key sections of the Hatch bill below. Continue Reading A “Surprise” Cosmetic Reform Bill Appears in Congress; Bipartisan Compromise Continues to Be Legislators’ Goal

As we have discussed in previous posts, Congress may be moving towards finally enacting some long-awaited cosmetics reform legislation this year. On January 13, Representative Pete Sessions (R-TX) reintroduced his cosmetics modernization bill as H.R.575. The package of reforms was first introduced in November 2015 as the Cosmetic Modernization Amendments of 2015 (H.R.4075).

Overall, the proposed legislation would amend the Federal Food, Drug, and Cosmetic Act with respect to FDA’s regulation of cosmetics by creating new requirements such as the registration of manufacturing establishments and the submission of a cosmetic and ingredient statement for each marketed cosmetic. It also would require cosmetic manufacturers, packers, and distributors to report to FDA any serious and unexpected adverse events caused by a cosmetic product. Likewise, cosmetic labels would be required to include contact information for consumers to report such events to the manufacturer or distributor.

Below, we break down in detail pertinent sections of the Sessions bill, as it was introduced in the previous Congress (although reports indicate that the reintroduced version has not been altered significantly). Continue Reading Cosmetics Reform Activity Begins in the 115th Congress

On December 6th, FDA announced that it is publicly releasing data received by the Agency’s Center for Food Safety and Applied Nutrition (CFSAN) about adverse events related to cosmetics and foods, including both conventional foods and dietary supplements.  Adverse events can be any negative reaction to a product, such as a serious illness or allergic reactions, or other complaints like packaging problems, that are received through FDA’s voluntary adverse event reporting systems for these classes of regulated products (except for in the case of dietary supplement manufacturers, who have mandatory reporting obligations).

The CFSAN Adverse Event Reporting System, called “CAERS,” includes data from reports submitted by consumers, medical professionals, and industry. The initial data file made public by the Agency contains CAERS data from January 2004 through September 2016. Continue Reading FDA Increases Transparency of Adverse Event Data for Cosmetics and Foods

Back in April 2015, Senators Dianne Feinstein (D-CA) and Susan Collins (R-ME) introduced the Personal Care Products Safety Act (S.1014).  More recently, on September 22, 2016, the Senate Health, Education, Labor, and Pensions Committee received testimony from Senators Feinstein and Collins in support of this bipartisan legislation.  The HELP Committee also heard from experts in the cosmetics industry about product developments and health standards.

Witnesses in favor of the Personal Care Products Safety Act stated that the FDA has not done enough to ban endocrine-disrupting chemicals in cosmetic products and that industry-financed review programs should not substitute government regulatory programs in collecting chemical toxicity data.  They contrasted FDA’s inability to ban products unless they are “adulterated” with the more expansive authorities of similar regulatory agencies in Canada, Japan, and the European Union. Continue Reading Coming Soon to a Lawbook Near You – New Cosmetic Requirements

Nail Salon ProductsThe “toxic trio” is a foreboding name some associate with common and seemingly innocuous manicures and pedicures. Salon workers suffer higher-than-average rates of birth defects, miscarriages, cancers, and skin afflictions stemming from their daily use of nail products, many of which contain potentially harmful chemicals. A New York Times exposé on the health conditions affecting nail salon workers has thrust this issue, which exists largely outside FDA’s authority, into the regulatory spotlight.

The toxic trio refers to the following three chemicals:  Continue Reading Hidden Costs of Common Beauty Treatments?

Cosmetics FDAWritten by: Michelle Gillette and Katherine Fox

Currently, FDA regulates cosmetics to ensure they are not adulterated or misbranded, but does not have the authority to order cosmetic recalls or require adverse event reporting.  Senators Dianne Feinstein (D-CA) and Susan Collins (R-ME) seek to change that.

On April 20, 2015, they introduced the Personal Care Products Safety Act (S.1014). The Act, if passed, would modify Chapter VI of the Federal Food, Drug, and Cosmetic Act (FDCA) to strengthen FDA’s oversight of, and regulatory authority over, cosmetic products.

Title I of the Act (“Cosmetic Safety”) gives FDA authority to order cosmetic recalls, as well as require manufacturers to: Continue Reading Are Cosmetics Gaining Higher Congressional and FDA Scrutiny?

Cosmetic Marketing Claims FDAIn addition to truthful and non-misleading advertising requirements, which are enforced by the FTC and certainly familiar to readers of this blog, personal care and cosmetic products are also subject to the Federal Food, Drug, and Cosmetic Act (the Act) and may run afoul of the U.S. Food and Drug Administration (FDA or the agency) if marketing or label claims for the products cross the line into the world of “drug claims.”

Over the past few months, FDA has issued several Warning Letters to personal care companies for making product claims that the agency has interpreted as drug claims.  This recent uptick in Warning Letters from the agency objecting to “drug-like” claims for cosmetic products is significant because it may indicate that FDA is increasing its scrutiny of aggressive marketing claims for these types of products.  There had been very few such letters since the agency made a high-profile enforcement sweep of the industry in late 2012.

Some of the statements in the marketing materials for certain personal care products that recently elicited FDA’s written warnings (and a public release of those warnings) made performance-related claims or claims that a product or ingredient was effective against a specific skin condition.  Examples of claims that the agency found to be objectionable include the following (among others): Continue Reading FDA Increasing Scrutiny of Cosmetic Marketing Claims, New Agency Warnings Suggest