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

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

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 an Enforcement Policy Statement on Marketing Claims for OTC Homeopathic Drugs  (available here); a Staff Report on the discussions held during the September 2015 workshop (available here); and an FTC blog post summarizing these actions.

For readers who are not familiar with homeopathy, the practice dates back to the 1700s and posits that disease symptoms can be treated by tiny doses of substances that produce similar symptoms if given in larger doses to healthy people (“like cures like”).  Accordingly, modern-day homeopathic remedies that we find ubiquitously in drug stores today are highly diluted formulations, which some people consider to be no more effective than placebo.  The FTC Staff Report provides an excellent overview of how this OTC industry has grown over the past 50 years and the viewpoints presented by both supporters and skeptics of homeopathy.

 The upshot to the new FTC Enforcement Policy is this:
 “No convincing reasons have been advanced either in the comments or the workshop as to why efficacy and safety claims for OTC homeopathic drugs should not be held to the same truth-in-advertising standards as other products claiming health benefits.”

Continue Reading FTC Issues Long-Awaited Enforcement Policy on OTC Homeopathic Drugs

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.

Howsare CohenThis article originally appeared on Law360 on May 12, 2016 and provides additional analysis to our prior post on this subject.

After filing a Section 15(b) report and conducting a recall with the U.S. Consumer Product Safety Commission (CPSC), companies frequently ponder whether the CPSC believes the company timely filed its report under Section 15(b) of the Consumer Product Safety Act (CPSA) and, if not, whether the CPSC will launch an investigation that could lead to a civil penalty action. Unlike the experience of negotiating a recall where there is frequent contact with the CPSC within a defined time frame, the agency is usually silent and takes more time (sometimes years) to decide whether it will investigate whether a company met the statutory time deadline for filing the underlying Section 15(b) report.

In many cases, determining that a report was filed in such a manner to where the CPSC likely would not find reason for a timeliness investigation or civil penalty is relatively straightforward. In other cases where the timeliness of a report is more uncertain, however, only the CPSC’s statute of limitations for pursuing a civil penalty can provide similar comfort.

So what is the CPSC’s statute of limitations? The answer is not as straightforward as it may appear.

Continue Reading When Does A CPSC Late Reporting Violation First Accrue?

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

CPSC and DOJ Stop Toy ImportsEarlier this week, the U.S. Department of Justice (“DOJ”)—at the behest of the CPSC—filed suit in California federal court against two companies and three individuals for importing products that violate the Federal Hazardous Substances Act (“FHSA”) and Consumer Product Safety Act (“CPSA”). The respective lawsuits can be accessed here and here.

The individuals and companies—Brightstar Group Inc. (“Brightstar”) and Unik Toyz Trading Inc. (“Unik Toyz”)—are accused of repeatedly importing children’s products and toys that contained high levels of lead, banned phthalates, small parts posing a choking hazard for young children. CPSC and DOJ also alleged that Unik Toyz and Brightstar continued these illegal activities despite receiving twenty-one and nine CPSC “letters of advice” (violation notices), respectively, over multiple years.

The companies and individuals have agreed to settle these charges by binding themselves to consent decrees (which can be accessed here and here). The consent decrees, which will go into force once entered by the court, are significant because they prohibit the companies and individuals from conducting any future business (selling, importing, or distributing) involving children’s products or toys until the CPSC verifies that certain far-reaching conditions are met—all of which relate to future compliance with CPSA and FHSA requirements.

The detailed and extensive conditions are set forth in the consent decrees and include, among other provisions: Continue Reading CPSC & DOJ Stop Two Companies from Future Importation of Children’s Products with Far-Reaching Consent Decrees

GMO Legislation

Today the Safe and Accurate Food Labeling Act of 2015 passed the House, in a vote of 275 to 150 (more information here). Still a hot-button issue, opposition to the Act is emotionally charged, with those opposed to the bill calling it the “DARK” Act (Denying Americans the Right to Know Act). Supporters of the bill, including farm, biotech, food, and beverage companies, argue mandatory labels would be expensive for companies and confusing for consumers.

H.R. 1599 stops states from mandating food labels on GMO products. The bill also calls for the creation of a voluntary USDA certification process for GMO-free foods and for FDA to regulate “natural” claims used on food labels. Groups advocating for labeling maintain that people should know what is in their food; since FDA already requires labeling of over 3,000 ingredients, additives, and food processes, GMOs should be no different. Supporters of Representative Pompeo’s (R-KS) bill, however, point to the dearth of any credible evidence showing foods produced with biotechnology pose any risks to health or safety.

The Associated Press reports that Senator Hoeven (R-ND) will introduce a companion to the Pompeo bill following the August recess. The Senate bill would put emphasis on amending federal agriculture laws, not food safety laws, to preempt state labeling efforts on GMOs. It will also emphasize a USDA GMO-free certification program and delineate how USDA’s Agriculture Marketing Service would oversee this effort, preempting any labeling by states that do not follow the same rules. Given the controversy surrounding GMOs, especially partisan divisions on state pre-emption and the “dangers” of genetic engineering, it remains to be seen if such legislation will be able to pass.  As always, we will keep an eye on the situation.

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?

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?