Manufacturer 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

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.

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

After launching with an ambitious agenda fourteen months ago (as we wrote about here), last Friday the Obama Administration announced that its Biotechnology Working Group had completed its two main tasks.  The Working Group has proposed an Update to the Coordinated Framework for the Regulation of Biotechnology, and it also completed work on a National Strategy for Modernizing the Regulatory System for Biotechnology Products. Together, these documents clarify the authority that Federal administrative agencies have to regulate certain products of biotechnology and they establish goals to ensure the proper use of those authorities in the future.

First, the Working Group’s proposed Update to the Coordinated Framework outlines the specific roles that FDA, USDA, and EPA serve to regulate biotechnology-derived products and the ways in which the agencies work together when those roles overlap. The Coordinated Framework, as noted in the Administration’s corresponding blog post, presents this information in three forms:

  • “graphics that illustrate agency-specific overviews of regulatory roles;
  • case studies that demonstrate how a product developer might navigate the regulatory framework; and
  • a comprehensive table that summarizes the current responsibilities and the relevant coordination across EPA, FDA, and USDA for the regulatory oversight of an array of biotechnology product areas.”

The Administration is soliciting public comment on its proposed Update. The deadline for submitting comments will be forty days after the Update is published in the Federal Register.

Second, the Working Group’s National Strategy dovetails with the Coordinated Framework, by listing a number of objectives related to the agencies’ use of their regulatory authorities. It groups these objectives under three overarching goals: “increasing transparency, increasing predictability and efficiency, and supporting the science that underpins the regulatory system.”

EPA, FDA, and USDA have agreed to report annually to the White House on their progress in meeting these three goals for at least the next five years. In addition, sometime soon, the Working Group plans to release a study on the future of biotechnology, the one item remaining on the group’s to-do list announced at its inception last year.

Consumer Product Matters will continue to follow the waning days of the Obama Administration and the transition to the next Administration – when the updated Coordinated Framework and the National Strategy ultimately will be put to the test.

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 Salmonella.  The two executives were sentenced last year for strict liability violations of the Federal Food, Drug, and Cosmetic Act (FDCA). Continue Reading Eighth Circuit Issues Decision Significant for All Executives of FDA-Regulated Businesses

The last of FDA’s seven “foundational” rules mandated under the Food Safety Modernization Act of 2011 (FSMA) was published at the end of last month, just a few days before the May 31, 2016 deadline agreed to by the Agency when it settled a lawsuit related to its implementation of FSMA (our posts on the previous six FSMA rules are here, here, and here). The newest Final Rule, titled Mitigation Strategies to Protect Food Against Intentional Adulteration, has an effective date of July 26th. Responding to calls from affected stakeholders that a one-year compliance deadline from the effective date, as proposed originally, would not be enough time for companies to meet these significant and brand-new obligations, FDA has increased the compliance dates to 3 years for most businesses (along with 4 years for “small” and 5 years for “very small” businesses, as those terms are defined in the Final Rule).

The purpose of these new regulations, according to FDA, “is to protect food from intentional acts of adulteration where there is an intent to cause wide scale public health harm,” and they establish requirements for covered food facilities to implement various food defense measures. Food defense consists of efforts to protect the food supply against intentional contamination due to sabotage, terrorism, counterfeiting, or other illegal, intentionally harmful means.  Continue Reading The Last Set of Major FSMA Regulations Are Done!