Natural Cosmetics: Products Without a Clear Definition

Consumer demand for natural cosmetics continues to grow. A Bloomberg News article projected the natural cosmetics market to grow over 5% annually and to be worth $48.04 billion by 2025. The article noted that high demand for natural products among millennials is “driving the growth,” which means the trend is likely to continue. Despite the increasing market share, the federal agencies that regulate the sale and advertising of cosmetics, the Food & Drug Administration (FDA) and the Federal Trade Commission (FTC), still have not formally defined the term “natural” as applied to cosmetics.
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FDA Warns Companies about Processing, Distributing and Marketing Unapproved Stem Cell Products

The U.S. Food and Drug Administration (FDA) has issued three letters (one warning letter and two untitled letters) over the last two months of 2019 directed at four different companies focused on the processing, distributing, and marketing of allegedly unapproved stem cell products derived from birth-related products, such as placentas, amniotic tissues, umbilical cords, and umbilical cord blood.

These products, which include human cells, tissue, and cellar and tissue-based products (also known as HCT products) are intended to treat a variety of orthopedic issues, autism, cardiac issues, dementia and arthritis. HCT products are considered “articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient.” Examples of HCT products include “bone, ligament, skin, dura mater, heart valve, cornea, hematopoietic stem/progenitor cells derived from peripheral and cord blood, manipulated autologous chondrocytes, epithelial cells on a synthetic matrix, and semen or other reproductive tissue.”

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Biotin Supplement Suit Dismissed on Preemption Grounds

A California federal judge tossed a proposed class action against allegedly “worthless” biotin dietary supplements on preemption grounds earlier this week, citing the Ninth Circuit’s recent decision in Dachauer v. NBTY, Inc., 913 F.2d 844 (9th Cir. 2019).

In Greenberg v. Target Corp., et al., the plaintiff filed a putative class action alleging that labeling for Target’s Up & Up brand of biotin dietary supplements was misleading under California’s Unfair Competition Law (UCL) and Consumer Legal Remedies Act (CLRA).

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Final Drug Pricing DTC Advertising Rule to Take Effect July 9 – But Faces Challenges from Pharmaceutical Companies

This winter we discussed new regulatory guidelines intended to increase transparency in Direct-to-Consumer (DTC) advertising including a proposed rule from the Centers for Medicare and Medicaid Services (CMS) that would require pharmaceutical manufacturers to list prices in DTC advertising for drugs costing $35 for a 30-day supply.

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Labeling Preemption Questions are for the Court, not the Jury, Holds U.S. Supreme Court in Fosamax Decision That Clarifies the “Clear Evidence” Standard

A judge, and not the jury, is the better-positioned and appropriate decisionmaker to determine whether a failure-to-warn claim is federally preempted, the U.S. Supreme Court held today.

The Court also clarified the “clear evidence” standard governing an impossibility preemption defense to failure-to-warn claims.

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The Presumption of Regularity in Prescription Drug Cases

In products liability cases involving prescription medicines, defendants sometimes rely on a preemption defense that FDA would not have approved – or in some cases, already rejected – the warnings that plaintiffs argue were required by state law.  Where the evidence shows FDA considered and rejected plaintiffs’ proposed warnings, plaintiffs often argue that the Agency would have approved their proposed warnings were it not for some technical issue.  For example, that FDA rejected the warning because the manufacturer asked to put it in the wrong section of the label or FDA would have approved it had the manufacturer asked rather than some third party in a Citizen’s Petition.  In rejecting such arguments courts often point, explicitly or implicitly, to the presumption of regularity, which “presumes” government agencies have “properly discharged their official duties” unless “clear evidence” shows otherwise.  See United States v. Chem. Found., Inc., 272 U.S. 1, 14-15 (1926); see also Nat’l Archives & Recs Admin. v. Favish, 541 U.S. 157, 174 (2004) (requiring “meaningful evidentiary showing” to rebut presumption of regularity).

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