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CPSC Sued Over Lack of Access to Consensus Standard Incorporated Into CPSC Regulation

May 26, 2020 | Blog | By Charles Samuels, Evelyn French, Evan Moore

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FDA Places Two Food Orders on Restaurants’ Tables

April 8, 2020 | Blog | By Daniel Herling, Nicole Ozeran

The food industry has been upended by the recent COVID-19 pandemic – restaurants and bars are scrambling to adjust to a new way of life after governors across America issued statewide “stay at home” orders in response to the coronavirus pandemic. Restaurants are now only permitted to serve take-out or drive-thru orders, and some restaurants have transformed themselves into neighborhood markets, or bodegas, selling food items not labeled for retail.
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In the latest challenge to Section 6(b), Congressman Bobby Rush has introduced HR 5565, the Safety Hazard and Recall Efficiency Information Act, which would amend Section 6(b) by stripping it of its most basic due process, as well as increasing enormously the penalties for late reporting.
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In a coordinated effort, the Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and the Environmental Protection Agency (EPA) launched a Unified Website for Biotechnology Regulation on January 9, 2020. The website serves to streamline information regarding agriculture biotechnology products, which are regulated by FDA, USDA, and EPA. The implementation of the website is in response to the June 2019 Executive Order issued by President Donald Trump on Modernizing the Regulatory Framework for Agricultural Biotechnology Products. The Unified Website for Biotechnology Regulation complements prior joint actions such as the Coordinated Framework for the Regulation of Biotechnology, an Obama administration effort to reform the biotechnology regulatory process by enhancing transparency, predictability, and efficacy.
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This is our third year-end post for 2019 related to the Food and Drug Administration (FDA), focusing on the agency’s activities in the widely divergent area of “consumer products.” (You can find our two prior posts on medical devices and prescription therapeutic products here and here, respectively.) In taking a wide-lens view of the past year, we see it as having presented a huge number of opportunities for the FDA to educate the public about its role in regulating non-prescription products sold directly to consumers. Most of the educational opportunities we highlight below came in concert with some other agency actions, like the issuance of Warning Letters to specific firms, but we’ve decided to cover only the key issues in the interest of keeping this post from turning into a long list of hyperlinks given the post’s already broad scope. Consumer products that fall within FDA’s jurisdiction include over-the-counter (OTC) drugs and OTC homeopathic drug products; tobacco and other nicotine delivery products; dietary supplements; foods and beverages for both humans and animals (technically, there is no such thing as an animal “dietary supplement”); cosmetics (sort of); and a wide variety of cannabis-derived consumer products that exploded onto the national landscape during 2019 and essentially cross into all of the aforementioned product categories.
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We have previously blogged about the Food and Drug Administration’s year of listening and information-gathering related to products containing cannabis or cannabis-derived compounds since the 2018 Farm Bill removed “hemp” from the federal Controlled Substances Act. Among other things, the Agency issued a call for scientific information on a variety of topics identified in this April 3, 2019 notice; opened a public docket to receive written comments in response to those questions (docket no. FDA-2019-N-1482); and convened a public hearing in May 2019 to hear from stakeholders directly. Our summary of that May 31st hearing, which also provides an overview of the legal and regulatory landscape post-2018 Farm Bill, is available here. This intensive period of evaluation was led by an internal working group charged with making recommendations for the open scientific, technical, and policy questions created by the new legal status of hemp.
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Do You Want Fries With That?

October 11, 2019 | Blog | By Daniel Herling

The old joke of “what do Philosophy majors ask at their first job?” takes on a new meaning in the world of Prop 65. On October 7, 2019, the California Chamber of Commerce filed a lawsuit in Federal court for the Eastern District of California (Complaint) challenging Proposition 65 warnings for food that contain the chemical Acrylamide. 
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Highlights of the FTC’s Workshop on Made in the USA Claims

October 3, 2019 | Blog | By Daniel Herling, Margaret Jewett

In Fleetwood Mac’s magnum opus, “Landslide,” Stevie Nicks croons, “Well, I’ve been ‘fraid of changin’ ‘cause I’ve built my life around you.” The FTC’s recent workshop on Made in the USA claims reveals a similar hesitancy to evolve, although panel discussions may presage altered approaches to enforcement of these claims. This workshop, held on September 26, consisted mainly of three panel discussions on various aspects of this issue.
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I suspect that we’ve all had this experience.  You’ve finished a long day of work, had dinner, and have cozied up on the couch with a glass of wine to watch a re-run of your favorite TV show.  The show goes to commercial and all of a sudden, plastered across your screen, there is an “important consumer alert” concerning the alleged dangers of a particular prescription drug and that “if you or a loved one have been injured” to contact this law firm. 
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Commissioner Bob Adler Elected Vice-Chairman of the CPSC, Making Him Acting Chairman of the Agency

September 13, 2019 | Blog | By Charles Samuels, Shawn Skolky, Evelyn French

It was confirmed that Commissioner Bob Adler was elected Vice-Chairman of the CPSC. Because there is no permanent CPSC Chairman at this time, Commissioner Adler will become the Acting Chairman of the agency until a permanent Chairman is confirmed. Commissioner Adler—a Democratic Commissioner—has served on the Commission since 2009.
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In a press release this afternoon, Acting Chairman Ann Marie Buerkle announced that she would be withdrawing her nomination to be the permanent Chairman of the CPSC, as well as her nomination for an additional 7 year term, which would have expired in October 2025
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As most folks with any interest in the burgeoning cannabidiol (CBD) industry likely know, on May 31, 2019, the Food and Drug Administration held a public hearing “to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.” Stakeholders who attended the hearing presented many diverse viewpoints and the FDA panelists – who were in listening mode – received extensive information from across that spectrum of perspective.
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FDA Ratchets Up Pressure on Homeopathic Drug Manufacturers

May 23, 2019 | Blog | By Benjamin Zegarelli

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.
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Case Study Hero Manufacturer Obtains Reversal CPSC Enforcement Action Mintz

Breaking: CPSC Notifies Numerous Companies of Unprecedented, Unauthorized Disclosure of Information

April 11, 2019 | Blog | By Charles Samuels, Shawn Skolky, Evelyn French

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.
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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.
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Unilateral Recalls: Companies Should Consider Launching Recalls Without the CPSC During the Government Shutdown

January 24, 2019 | Blog | By Charles Samuels, Evelyn French, Shawn Skolky

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.
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Costco Agrees to $3.85 Million Civil Penalty for Failure to Report, Accepted by Unanimous CPSC Vote

October 8, 2018 | Blog | By Charles Samuels, Shawn Skolky, Evelyn French

On Friday, October 5, 2018, the U.S. Consumer Product Safety Commission (“CPSC”) announced that Costco Wholesale, Corp. (Costco) entered into a settlement agreement with the CPSC to pay a $3.85 million civil penalty for its alleged failure to report defective trash cans. The penalty agreement was accepted 4-0 by the Commission. Notably, this is the first multi-million dollar civil penalty in the post-CPSIA era where there was not a Democratic majority at the CPSC, indicating that penalty actions are far from moribund under the current leadership.
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CA Prop 65 Coffee Issues Still Brewing

September 4, 2018 | Blog | By Daniel Herling

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. 
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