Header graphic for print
Consumer Product Matters A product safety and consumer related regulation and litigation blog

Category Archives: Drugs & Cosmetics

Subscribe to Drugs & Cosmetics RSS Feed

OTC Drug Manufacturers: Keep Your Eyes and Ears on Congress

Posted in Drugs & Cosmetics, Federal Regulations, Food & Drug Administration (FDA), U.S. Congress

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 a public meeting to solicit stakeholder feedback on… Continue Reading

Cosmetics Reform Activity Begins in the 115th Congress

Posted in Consumer Product Safety, Drugs & Cosmetics, Federal Regulations, Food & Drug Administration (FDA), Manufacturer Product Safety, Private Labeler Product Safety, U.S. Congress, Uncategorized

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… Continue Reading

FDA Increases Transparency of Adverse Event Data for Cosmetics and Foods

Posted in Consumer Product Safety, Drugs & Cosmetics, Federal Regulations, Food & Drug Administration (FDA), Food and Beverage, Product Liability

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… Continue Reading

FTC Issues Long-Awaited Enforcement Policy on OTC Homeopathic Drugs

Posted in Advertising, Children's Products, Consumer Product Safety, Drugs & Cosmetics, Federal Regulations, Federal Trade Commission (FTC), Manufacturer Product Safety, Product Liability

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 post we mentioned that both FDA and the Federal Trade Commission (FTC) held public workshops in 2015 to gather information about this uniquely-regulated class of consumer products.  Today, FTC released… Continue Reading

Coming Soon to a Lawbook Near You – New Cosmetic Requirements

Posted in Consumer Product Safety, Drugs & Cosmetics, Federal Regulations, Food & Drug Administration (FDA), Manufacturer Product Safety, Private Labeler Product Safety, U.S. Congress

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… Continue Reading

Homeopathic Products Under Renewed Scrutiny Following FDA’s Consumer Warnings

Posted in Children's Products, Consumer Product Safety, Drugs & Cosmetics, Federal Regulations, Food & Drug Administration (FDA), Manufacturer Product Safety, Private Labeler Product Safety

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 six years (since a 2010 consumer alert about… Continue Reading

Eighth Circuit Issues Decision Significant for All Executives of FDA-Regulated Businesses

Posted in Drugs & Cosmetics, Federal Regulations, Food & Drug Administration (FDA), Food and Beverage, Litigation, Manufacturer Product Safety

On July 6, 2016, the Eighth Circuit Court of Appeals issued its ruling in United States v. DeCoster, in which it upheld prison sentences for two executives under the “responsible corporate officer” (RCO) doctrine of liability, also called the Park doctrine, for their role in introducing into interstate commerce eggs that had been adulterated with… Continue Reading

OTC Drug Regulatory Paradigm Open to Stakeholder Feedback Until July 10

Posted in Drugs & Cosmetics, Federal Regulations, Food & Drug Administration (FDA)

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 Health Affairs that FDA’s “current system of… Continue Reading

California Plaintiffs Say that Size Matters: Consumer Fraud Class Action Challenges Slack-Fill in Protein Products

Posted in Advertising, Consumer Product Safety, Drugs & Cosmetics, Food and Beverage, Litigation, Manufacturer Product Safety, Private Labeler Product Safety

According to named plaintiffs in a consumer fraud action filed in December in the Southern District of California, size matters when making it comes to making a purchase.  In fact, Plaintiffs claim that the average consumer’s purchasing decision is “heavily dependent” on the size of the package. Plaintiffs have sued Defendant MusclePharm for “intentionally packaging its… Continue Reading

Fraudulent Dietary Supplements Highlighted in the 2016 National Consumer Protection Week

Posted in Consumer Product Safety, Drugs & Cosmetics, Federal Regulations, Food & Drug Administration (FDA), Food and Beverage

In case you hadn’t heard about it or didn’t get involved in any of the events hosted by various campaign members, the week of March 6-12 was National Consumer Protection Week.  Besides the usual efforts to educate the public about our basic rights as consumers, the risks of identity theft, and certain types of scams such as… Continue Reading

The Continuing Conundrum of the California Food Fight

Posted in Drugs & Cosmetics, Federal Regulations, Food & Drug Administration (FDA), Food and Beverage, Litigation

We have blogged regularly about the plethora of litigation, largely centered in California, focused on the labeling of food, beverage, cosmetics, and consumer goods.  Nationwide, consumers are demanding more information from manufacturers and retailers of these goods, and companies in the relevant industries seem ready, willing, and able to provide that information.  This is evidenced by many… Continue Reading

Legislative Action to Remove Microbeads from Personal Care Products Intensifies

Posted in Drugs & Cosmetics, Federal Regulations, Manufacturer Product Safety, State Consumer Protection Laws, State Regulations, U.S. Congress

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 desk for his signature.  Although several states already… Continue Reading

Does CPSC or FDA Have Jurisdiction Over Your Consumer Product?

Posted in Consumer Product Safety, Consumer Product Safety Commission (CPSC), Drugs & Cosmetics, Federal Regulations, Food & Drug Administration (FDA), Food and Beverage, U.S. Congress

As our readers know, we write about legal developments that affect companies involved in manufacturing, importing, distributing, and/or selling “consumer products.” In many cases, these products fall squarely within the jurisdiction of the Consumer Product Safety Commission (CPSC). But when is a so-called consumer product not regulated by the CPSC? Or, when does the CPSC… Continue Reading

Hidden Costs of Common Beauty Treatments?

Posted in Consumer Product Safety, Drugs & Cosmetics, Food & Drug Administration (FDA), Litigation, Manufacturer Product Safety, Product Class Actions, Product Liability, Retailer Product Safety, State Consumer Protection Laws

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 Times exposé on the health conditions affecting… Continue Reading

Class Action Defense Counsel adding ‘The Pick Off’ to Their Playbooks

Posted in Consumer Product Safety, Drugs & Cosmetics, Litigation, Product Class Actions, Retailer Product Safety, State Consumer Protection Laws, State Unfair Competition Laws

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 offer, argue that the fact that they were offered… Continue Reading

FDA Issues Draft Guidance Regarding Controlled Correspondence from Generics Manufacturers

Posted in Drugs & Cosmetics, Federal Regulations, Food & Drug Administration (FDA), Manufacturer Product Safety

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 issued this guidance as part of its… Continue Reading

U.S. Supreme Court: Pom’s Mislabeling Suit Against Coke Not Precluded by FDA Regulations

Posted in Advertising, CPSC Enforcement Actions, Drugs & Cosmetics, Federal Regulations, Food & Drug Administration (FDA), Food and Beverage, Litigation

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 food and beverage labeling under the Federal Food,… Continue Reading

Green Chemistry Initiatives: An American Patchwork?

Posted in Consumer Product Safety, Drugs & Cosmetics, Importer Safety, Manufacturer Product Safety, Prop 65, State Consumer Protection Laws, State Regulations

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. For instance, starting on November 22, 2013 manufacturers no longer need to report the presence of n-butanol in children’s products to… Continue Reading

California Cuts Manufacturers Some Slack

Posted in Advertising, Consumer Product Safety, Drugs & Cosmetics, Food and Beverage, Litigation, Manufacturer Product Safety, Private Labeler Product Safety

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 perpetration of deception or fraud”.  A container… Continue Reading

Down the Rabbit Hole: Primary Jurisdiction Redux

Posted in Advertising, Consumer Product Safety, Drugs & Cosmetics, Food & Drug Administration (FDA), Food and Beverage, Litigation, Product Class Actions, Product Liability, State Consumer Protection Laws

“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.’” While perhaps not as far down the rabbit hole as Alice was, the Courts within the Northern District of California are decidedly split on whether to use the… Continue Reading

“Natural” Labeling on the Decline?

Posted in Advertising, Consumer Product Safety, Drugs & Cosmetics, Food & Drug Administration (FDA), Food and Beverage, Litigation, Product Liability

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 regulatory guidance on the term.  It will… Continue Reading

The Food Court Kicks the Proper Use Of The Term “Natural” To FDA

Posted in Advertising, Drugs & Cosmetics, Food & Drug Administration (FDA), Food and Beverage, Litigation, Product Liability, State Consumer Protection Laws, State Unfair Competition Laws

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 a recent ruling on a motion to… Continue Reading

The GMO Controversy Continues to Swirl

Posted in Advertising, Drugs & Cosmetics, Food & Drug Administration (FDA), Food and Beverage, Litigation, Product Class Actions, Product Liability

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 fields, stiff-legged and neck-bolted. Several states have… Continue Reading

Use of the Primary Jurisdiction Doctrine in a “Natural” cosmetics case

Posted in Drugs & Cosmetics, Federal Regulations, Food & Drug Administration (FDA), Food and Beverage, Litigation, Product Liability

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 would view the issue, Judge Phyllis J…. Continue Reading