Private Labeler Product Safety

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

Another Federal agency with a consumer-protection mandate has taken a significant step to reset compliance expectations and enforcement priorities for over-the-counter homeopathic drug products. Although we will not re-cap the recent history of the industry here so we can keep this post a reasonable length, in late 2016 the Federal Trade Commission (FTC) announced its long-awaited policy for the advertising and marketing of OTC homeopathic drugs (see prior post here). The FTC’s action followed two public workshops convened in 2015 to deliberate a multitude of thorny legal and regulatory issues associated with consumer-directed homeopathy – one hosted by the FTC and the other hosted by the Food and Drug Administration (FDA). Written comments were also collected after both public meetings.

On December 18, 2017, FDA finally released a revised enforcement policy (in draft form) following this robust and comprehensive re-examination of the regulatory framework for homeopathic products. The enforcement policy applies only to human drugs labeled as homeopathic and sold without FDA premarket approval. Continue Reading FDA Resets Enforcement Priorities for OTC Homeopathic Drugs

It has recently been reported that President Donald Trump is looking for ways to defend American-made products by certifying legitimate U.S. goods and aggressively going after imported products unfairly sporting the “Made in America” label, the White House said on July 18, 2017. President Trump announced that his administration would crack down on “predatory online sales of foreign goods” that are hurting U.S. retailers. According to a senior official, the United States loses about $300 billion a year to theft of intellectual property ranging from semiconductors to jeans. In March of this year, the President signed an executive order that gave customs officials more authority to stop pirated and counterfeit items.

This space has addressed the issues, both regulatory and litigation, relating to “Made in America” claims (see herehere, and here). Based on the Administration’s comments,  the White House plans to work with the private sector on the new certification and verification system rather than create new regulations or spend taxpayer money. Continue Reading The Turn of the “Made in America” Claim Enforcement

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

Our colleagues in Mintz Levin’s Intellectual Property Practice, Aarti Shah and James Wodarski, recently authored an expert analysis piece in Law360 that examined the use of the U.S. International Trade Commission (ITC) to combat a rising tide of counterfeits and knockoffs in all kinds of consumer product industries.  Aarti tells us that, in addition to the potential for reputational harms to the targeted Brand, many of the counterfeits often are poorly made.  Sometimes they even bear completely false UL or Energy Star certifications.  Accordingly, they can raise a host of serious safety concerns that can directly and adversely affect the Brand through no fault of its own.

Examples of poor quality counterfeit products that actually harmed consumers and tarnished the Brand name are described in Aarti and James’s article.  In one illustrative case, Farouk Systems, Inc., owner of the CHI™ mark used for high-end hair irons and hair products, faced with a flood of counterfeits and knockoffs that were entering the market through websites, distributors, and eBay.  Farouk filed over 21 lawsuits in the U.S. district courts; hired a company to monitor Internet websites selling unauthorized Farouk products; and worked with eBay to prevent sales of knockoffs on that site – and it was still unable to slow down the influx of infringing products, thus leading it to seek protections through the ITC process.  Even worse from the perspective of those of us who worry about consumer product safety and products liability, Farouk was receiving daily calls from customers regarding poorly made, faulty products – which in most cases turned out to be counterfeits.

Aarti and James’s full article can be viewed here.  We recommend it as a quick read for  every manufacturer, private-labeler, and retailer of consumer products who faces counterfeiting or other forms of serious Brand dilution.

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

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 certain ingredients in the same products).  The Agency is warning parents and caregivers to seek medical care immediately if an infant or child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using homeopathic teething tablets or gels. It is also advising consumers to dispose of any such products they may have in their possession. Continue Reading Homeopathic Products Under Renewed Scrutiny Following FDA’s Consumer Warnings

Slack Fill Protein PowderAccording 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 [protein products] in large, opaque containers that contain more than 45% empty space” or—as Plaintiffs have characterized it—non-functional slack-fill.  Plaintiffs argue that consumers paid a higher price for the products because of the large containers, but they would not have purchased those products if they had known the containers were substantially empty.

For manufacturers of consumer products, the best option to avoid these types of slack-fill lawsuits is to follow these guidelines in product packaging: Continue Reading California Plaintiffs Say that Size Matters: Consumer Fraud Class Action Challenges Slack-Fill in Protein Products

Although not quite meeting the deadline of October 31 established in a legal settlement last year, FDA has released a set of three more “foundational” Final Rules mandated by the Food Safety Modernization Act (FSMA or the Act). The Final Rules on Foreign Supplier Verification Programs, produce safety, and accredited third-party certification were released by FDA in pre-publication format on November 13, and they will be published in the Federal Register on November 27, 2015.

That official publication date will be key for calculating individual compliance dates for businesses covered by the FSVP and produce safety rules, as those rules stagger compliance depending on business size and other factors, as do the final preventive controls for human and animal food. We blogged about those first two FSMA Final Rules back in mid-September, and the last two rules related to sanitary transportation and intentional contamination of food are expected to be finalized next year, in March and May, respectively.

Readers of this blog may be most interested in the FSVP and third-party certification rules, which are both designed under the Act to enhance the safety of imported food. Continue Reading Three More FSMA Rules Finalized As the Year Comes to a Close

US CPSC Fast Track Recall ProgramSo what is the CPSC’s “fast track recall” program and what is the benefit of participating in it? What is a “stop sale notice” and why does the CPSC generally request it for fast track recalls? What else is required by the CPSC in order to participate in the program and what are the potential downsides? When should a company utilize fast track? These are common questions for companies who believe they could have a product safety issue and are already seriously considering a voluntary recall.

What is the CPSC “Fast Track Recall” Program?

Continue Reading What is CPSC’s Fast Track Recall Program and When Should Companies Utilize It?

Consumer product safety testingAt their April Senate confirmation hearing, both incoming CPSC Chairman Elliot Kaye and Commissioner Joe Mohorovic pledged to Senator John Thune (R-SD) to submit plans for reducing third party testing burdens within 60 days of confirmation. Rather than send separate plans, Kaye and Mohorovic submitted a joint letter to Senator Thune recently made public on the website for the U.S. Senate Committee on Commerce, Science, and Transportation.

The letter outlines three areas of focus for the agency to reduce testing burdens: Continue Reading CPSC Focusing on Three Areas for Reduction of CPSIA Testing Burdens