Retail & Consumer Products

On May 14, FDA announced that it issued five Warning Letters to companies that manufacture and market homeopathic drugs for human use. The letters all cite cGMP deficiencies relating to inspectional observations and conclude that the products are misbranded prescription drugs under the Federal Food, Drug, and Cosmetic Act because “in light of their toxicity or other potentiality for harmful effect, or the method of their use, or the collateral measures necessary to their use, they are not safe for use except under the supervision of a practitioner licensed by law to administer such drugs” and they are not labeled for prescription use only.

In 2019 so far, FDA has issued Warning Letters to eleven separate homeopathic drug manufacturers, including the five letters referenced above. All of the Warning Letters, except one, cite observations from inspections and focus on cGMP and quality violations at the manufacturing facilities, including contamination and varying amounts of active ingredients, that could lead to consumer harm.

As predicted by our colleagues earlier this month, outgoing Commissioner Scott Gottlieb of the U.S. Food and Drug Administration (FDA) released a comprehensive press release setting forth actions for possible FDA regulation of CBD products. FDA also reinforced its position that introducing CBD or THC infused products into interstate commerce, including marketing CBD and THC dietary supplements, continues to be illegal.  In furtherance of this position, FDA released three warning letters to businesses marketing CBD products for using “egregious and unfounded claims aimed at vulnerable populations.”

Recently, the U.S. Consumer Product Safety Commission (CPSC) informed what could turn out to be a very large number of consumer product companies that it discovered what appears to be a mass inadvertent disclosure of nonpublic manufacturer and product specific information.

Regulation of cannabidiol (CBD) was a hot topic on Day 1 of ACI’s Cosmetics & Personal Care Products conference on March 28, 2019. Attendees asked many questions about legitimate uses of and claims for CBD, but definite answers were in short supply due to the current confusion over the legality of CBD as a product itself or other products, such as food or cosmetics, with CBD added.

When asked a direct question about FDA’s perspective on and plans for CBD regulation, Dr. Linda Katz, Director of FDA’s Office of Cosmetics and Colors and Acting Chief Medical Officer for Food Safety and Applied Nutrition, did not comment directly but referred all attendees to an upcoming public meeting on CBD in April 2019. It is possible that the public meeting could be the start of an FDA rulemaking process for CBD regulations. Even though Dr. Katz was unable to comment, there was still plenty of CDB advice to share with industry attendees.

Commissioner Elliot Kaye recently released a framework, which he co-authored with his Senior Science and Policy Advisor, Dr. Jonathan Midgett, that provides an “overview of technology-neutral best practices to ensure consumer product safety in the design and deployment of devices, software and systems used with the Internet-connected consumer products.” This framework should prove useful to consumer product companies as they navigate the burgeoning world of IoT devices.

Now in its fifth week, the partial government shutdown has left many companies wondering what to do about recalls for consumer products. Generally, consumer product companies work in coordination with the U.S. Consumer Product Safety Commission (“CPSC”) when conducting recalls. But like other affected agencies, the CPSC is currently operating with only its essential staff members, which is about 20 or fewer employees.

As has been widely reported, in May 2018, a Los Angeles Superior Court judge ruled that Prop 65 warning labels are required to be placed on “ready-to-drink” coffee products. Acrylamide, a Prop 65 listed chemical that allegedly is a carcinogen, forms during the coffee roasting process. 

One week after a San Francisco jury decided against Monsanto and awarded a plaintiff $289 million due to the alleged exposure that caused his cancer, the California Supreme Court refused to hear any further challenges by Monsanto.

On July 1, 2018, California’s revised Automatic Renewal Law (ARL), Cal. Bus. & Prof. Code § 17600 et seq., goes into effect.

Recently, a federal judge sitting in the Eastern District of California (Sacramento), for the first time, refused to require a manufacturer to place a Prop 65 warning on its product based on a finding that the requirement would violate the company’s First Amendment rights. We have been following this developing issue for some time.

The consumer product safety community is rarely provided guidance by federal court decisions. On Tuesday, however, Judge R. Brooke Jackson of the Federal District Court for the District of Colorado issued an opinion in the never-ending saga of Zen Magnets, LLC v. CPSC.

Fresh off a victory in the CA primary, California Attorney General Xavier Bacerra filed suit on June 7, 2018 against Nutraceutical Corporation of Park City, Utah and Graceleigh, Inc. dba Sammy’s Milk of Newport Beach, CA, alleging violations of California’s Proposition 65 and California’s consumer protection laws.

As this space has addressed before (see here and here), the California Transparency in Supply Chain Act (Civ. Code section 1714.43), enacted in 2010, requires large retailers and manufacturers (those with worldwide sales in excess of $100 million) doing business in California to disclose on their websites.

Yesterday, President Donald Trump nominated Peter Feldman to fill the fifth and final spot as Commissioner of the U.S. Consumer Product Safety Commission.

As this space has discussed on several occasions, there are many issues with California's Prop 65.

Yesterday the U.S. Senate confirmed Dana Baiocco (pronounced “Bee Awe Co”) as a Commissioner for the U.S. Consumer Product Safety Commission with a term that runs through October of 2024.

A recent Federal Court decision on the issue of whether to grant a preliminary injunction in the ongoing saga of the appropriateness of adding the pesticide Glyphosate to the CA Prop 65 list has become the grist for the "Fake News" phenomenon.

On Friday, February 16, the U.S. Consumer Product Safety Commission (“CPSC”) announced that it had voted 3-1 (along party lines) to authorize CPSC staff to file an administrative complaint against Britax Child Safety, Inc., (“Britax”) a global manufacturer of car seats, strollers, and other juvenile products.

Much of the recent discussion regarding Prop 65 has been focused on the regulatory changes going into effect in August of 2018. And that makes sense since there will be significant changes to the warnings, responsibility, and labeling obligations on product websites.

With Congress back in session, on January 8th President Trump was swift to re-nominate Acting Chairman Ann Marie Buerkle to be the permanent Chairman of the CPSC, along with a nomination for a second term as a Commissioner.  President Trump also re-nominated Dana Baiocco to be a Commissioner.