The U.S. Consumer Product Safety Commission (CPSC) and Peloton Interactive, Inc. (Peloton) are clashing over whether the media, technology, and fitness company should issue a recall of its treadmill, the Peloton Tread+. The disagreement came to a head on Saturday, April 17, when the CPSC and Peloton issued competing statements after failing to agree on language to be used in a joint announcement regarding the Tread+. This dispute raises the question, “What now?”
Category: Regulatory
FDA Announces Increased Inspections and Enforcement Actions, Additional Guidance to Reduce Toxic Elements in Food for Babies and Young Children
On March 5, 2021, FDA issued a public statement announcing regulatory actions to reduce toxic elements — with a particular focus on arsenic, lead, cadmium and mercury — in food for babies and young children. FDA cited the risk heavy metals pose to infant and young children’s neurological development. The Agency indicated that it would take the following actions:
SCOTUS Denies Certiorari in Cases Concerning FCA Liability Requirement, Objective Falsity Circuit Split Remains Intact
The United States Supreme Court denied certiorari without comment in two cases seeking to resolve a Circuit split regarding the proof required to establish that a claim for payment was false or fraudulent under the False Claims Act.
Two Petitioners asked the Court to decide whether the False Claims Act, 31 U.S.C. §§ 3729-3733, requires proof of “objective falsity”, or whether a plaintiff expert’s opinion that differs from the judgment of the defendant is sufficient to show a claim for payment was false or fraudulent under the FCA. Both cases involved allegations that a physician’s certification of medical necessity for hospice services was false, and therefore sufficient to prove plaintiffs’ FCA claims.
FDA Issues Guidance for Applicants Seeking Biosimilar/Interchangeable Approval
The Food and Drug Administration (FDA) released new draft guidance, Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act, intended for prospective applicants of biologics license applications (BLAs) for biosimilar and interchangeable products, and for other parties interested in the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This new guidance aims to further facilitate the development of proposed biosimilar products and proposed interchangeable products.
The BPCI Act created an abbreviated licensure pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product. This newly released draft guidance is the third FDA question-and-answer guidance on the BPCI Act, with the previous two released in December 2018: Questions and Answers on Biosimilar Development and the BPCI Act Guidance for Industry and New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2).
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Preemption of Structure/Function Claims
Seen frequently on grocery items, and especially on dietary supplements, structure/function claims describe the role of a nutrient or ingredient in the structure or function of the human body. Examples include “Calcium builds strong bones,” “St. John’s Wort supports mood,” and “Vitamin E supports the immune system.”
The FDA defines and regulates structure/function claims, and FDA requirements generally preempt state-law requirements that are “not identical.” 21 U.S.C. § 343-1(a)(5). So, does compliance with FDA regulations for structure/function claims shield food and supplement manufacturers from lawsuits claiming their structure/function claims are false and misleading?
“Fruit Puree” Held a Fair Game First Ingredient in Fruit Snacks Label by California Court of Appeal
The California Court of Appeal, First Appellate District, recently affirmed judgment in favor of a fruit snack manufacturer who claimed “fruit” was stated to be the first ingredient on a front label but listed “fruit puree” first in the product’s ingredient list.
Plaintiff’s Fruit Snack–Based Claims
Defendants in Iglesias v. Welch Foods, Inc., et al., No. A159565, manufactured fruit snacks with a label that stated, “Fruit is our 1st Ingredient!” at the top of the front label. The snacks’ “Nutrition Fact Panel” then listed “FRUIT PUREE” as the first ingredient, followed by corn syrup.