Subject: Food Products

FDA Publishes New Artificial Intelligence & Medical Products White Paper

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On March 15, the United States Food & Drug Administration published a white paper entitled “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” FDA announced the paper by sharing a short letter from Commissioner Califf, where he reaffirmed the Agency’s commitment to “promoting the responsible and ethical development, deployment, use, and maintenance of safe and effective medical products that incorporate or are developed with AI.” The white paper does not contain any new pronouncements of FDA position, but refers to existing guidance and serves as a reinforcement for existing FDA policy regarding AI.

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It’s an MDL World: Agreement is enough, or is it?

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The JPML held its second hearing of 2022 at the end of March. We addressed the results of the first hearing recently here, and further observed the JPML’s trend over the course of the last several years in forming fewer MDL proceedings each year. As we move further into 2022, it is clear this trend has continued.

In April, the JPML formed two new MDLs out of four total petitions, bringing the cumulative total of new MDLs in 2022 to four (out of seven petitions considered)—well below the typical quarterly pace for new MDLs, including that of 2021. Through its orders, the JPML provided insights into the circumstances that justify MDL formation, and those that do not. We briefly discuss these orders below:

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FDA Finalizes Voluntary Recall Guidance Imploring Companies to Be “Recall Ready”

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FDA recently issued final guidance regarding the initiation of voluntary product recalls and its related suggestions on how to be “recall ready.” The guidance – covering voluntary recalls of food, drugs, devices, biological products, cosmetics, and tobacco – emphasizes the importance of a company’s recall readiness at all stages of a product’s distribution chain and provides companies with suggested measures to prepare for and implement voluntary recalls. It also advises companies on best practices for working with FDA to initiate a timely voluntary recall.

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Tenth Circuit Affirms Dismissal of Pet Food False Ad Proposed Class Action

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The Tenth Circuit recently affirmed dismissal of a proposed class action against a dog food manufacturer, finding that the putative class claims were nonactionable puffery and overly subjective.

In Renfro, et al. v. Champion Petfoods USA, Inc., et al., No. 20-1274, pet owner plaintiffs brought a proposed class action against Champion Petfoods alleging that the packaging for some of its dog food brands were false and misleading. Specifically, plaintiffs asserted claims for violation of the Colorado Consumer Protection Act, breach of express and implied warranty, fraudulent misrepresentation, fraudulent concealment, unjust enrichment, and negligence.

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Challenging Price Premium Allegations Can Pay Off for Defendants

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Motions to dismiss in consumer fraud cases often focus on the element of deception—whether a reasonable consumer would be deceived by the statement or practice at issue. But there is another element of statutory consumer fraud claims that deserves closer scrutiny at the pleading stage—injury. Where plaintiffs claim that they were injured because they paid a “price premium” but do not allege facts to support that claim, defendants should consider moving to dismiss for failure to adequately plead injury.

State consumer protection statutes typically include injury as a required element for a private cause of action. New York General Business Law Sections 349 and 350, for example, require a plaintiff to establish that she purchased a product because of the allegedly deceptive business practice and did not receive the full value of the purchase. Similarly, plaintiffs suing under California’s Unfair Competition Law, False Advertising Law, or Consumer Legal Remedies Act must establish that they suffered an “economic injury” caused by the practice or advertising at issue.

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New Phthalates Study Garnering Media Attention Purports to Show Only an Association – Not Causation – with Certain Mortalities

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A new study regarding phthalates has garnered media attention this month, but readers should recognize the study’s limitations.  Some media coverage of this study blurs the important distinction between “association” and “causation.”

What Are Phthalates?

Phthalates, sometimes called plasticizers, are a group of chemicals generally used to make plastics more durable, or to dissolve other materials.  Phthalates may be found in products such as vinyl flooring, food wraps, intravenous tubing, lubricating oils, and some personal care products such as shampoos, soaps, and hairsprays.

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