Drugs & Cosmetics

Happy New Year! And now on to your regular Consumer Product Matters programming…

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…

As we previously blogged about in mid-2016, Food and Drug Administration officials have been exploring and pushing for the creation of a new user fee program to support its regulatory activities related to over-the-counter (OTC, also known as nonprescription) drug products. In June of 2016, the Agency held…

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…

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,…

We reported a few weeks ago about a new warning from FDA related to the safety of certain teething-related, non-prescription homeopathic drug products, and in that pos t we mentioned that both FDA and the Federal Trade Commission (FTC) held public workshops in 2015 to gather information about…

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…

Last week, following up on a more general warning issued on September 30, FDA alerted the public that it had received at least 10 reports of baby deaths associated with the use of homeopathic teething products, as well as over 400 other adverse event reports over the past…

Continuing a discussion that began in 2014, on June 10, 2016 FDA hosted a public meeting on the potential development of a user fee program for OTC (over-the-counter, or nonprescription) drug products marketed pursuant to the Agency’s monograph system. Agency leader Dr. Janet Woodcock wrote last week in…

The International Campaign Against Microbeads in Cosmetics is most likely celebrating this week, following the California State Legislature’s passage of a bill that would prohibit the use of plastic microbeads in personal care products after January 1, 2020. The bill, AB 888, now heads to Governor Jerry Brown’s…

The “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…

In recent years, we’ve noticed a new maneuver that class-action defense counsel have increasingly added to their playbooks: The Pick Off. This is how the play is run: Offer the named plaintiff(s) full relief through a Rule 68 offer of judgment and, even if the plaintiff(s) reject the…

On August 26, 2014, the FDA issued draft guidance to address “controlled correspondence,” which is the correspondence that generic drug manufacturers submit to the FDA to request information and to clarify issues related to generic drug development, and the FDA’s procedure for responding to such correspondence. The FDA…

Yesterday the Supreme Court ruled, 8-0, that Pom Wonderful LLC could pursue mislabeling claims under the federal Lanham Act against the Coca-Cola Company, even though the label at issue complied with FDA labeling regulations. The decision reversed the Ninth Circuit’s 2012 ruling that the FDA’s “comprehensive regulation” of…

A growing number of states are passing Green Chemistry laws, e.g.; California, Connecticut, Maine, Minnesota, and Washington State. These laws present a challenge to manufacturers who distribute and sell products into the 50 states.

As this space has pointed out on several occasions, California’s laws are nothing, if not unique. One such law is California’s Business & Professions Code Section 12606.2 which prohibits a container or package from having false bottoms, false sidewalls, a false lid or covering or to “facilitate the…

“When I use a word,’ Humpty Dumpty said in rather a scornful tone, ‘it means just what I choose it to mean — neither more nor less.’”

Manufacturers are removing “natural” statements from their labels, both as part of lawsuit settlements and as an alternate marketing strategy. PepsiCo has agreed to remove the phrase from its Naked juices after a lawsuit was filed against it in California, stating that it will wait for more detailed…

In what may be an indication of things to come, the Food Court (US District Court Northern District of California) has decided to ask FDA for guidance on what it wants on food labels. The Food Court directly addressed the labeling of foods containing GMOs as “natural” in…

Some are concerned that the potential health consequence of the use of genetically modified organisms in food is unknown because of the lack of long-term testing proving that it is safe. Fearful consumers imagine “Franken foods,” conjuring up images of over-sized ears of corn that shuffle about the…

When should a court decide a case that has issues involving an area that Congress has already weighed in on? In the case of cosmetics and FDA, when a lawsuit requires a court to decide an issue committed to FDA’s expertise without a clear indication of how FDA…