Understanding Legislation, Regulations, and Standards in the Cosmetics Industry

Support Grows for an Updated FDA Regulatory Framework for Dietary Supplements and Cosmetics

In recent developments, two former U.S. Food and Drug Administration (FDA) commissioners, along with leaders from four prominent cosmetics industry associations, have urged Congress to advance legislation aimed at modernizing the FDA’s regulatory framework for dietary supplements and cosmetics. This call to action highlights the critical need for enhanced oversight and accountability to ensure consumer safety and product integrity.

In an influential article published in JAMA Forum in October, former FDA Commissioners Scott Gottlieb and Mark B. McClellan expressed their concerns regarding Congress’ inaction on important provisions related to dietary supplements and cosmetics. They labeled the lack of progress as “a profound missed opportunity” that could significantly impact public health and safety.

The proposed legislation would mandate that all manufacturers of dietary supplements notify the FDA whenever a new product is introduced or an existing one is modified. This notification would also include detailed information on the composition of ingredients, intended dosage, and serving size, thereby enhancing the transparency and safety of dietary supplements available to consumers.

Regarding cosmetic oversight, Gottlieb and McClellan noted that while most cosmetic products are generally safe, consumers currently lack reliable information about the ingredients in their cosmetics. They emphasized the absence of mechanisms to alert consumers about safety issues or protect them if manufacturers neglect to address known risks. This lack of transparency could lead to significant consumer harm.

The proposed legislation aims to empower the FDA with the authority to recall cosmetics that contain potentially harmful ingredients. Additionally, it would require cosmetic companies to report any serious adverse health effects associated with their products to the FDA, enhancing the agency’s ability to safeguard consumer health.

This article is part of a broader advocacy effort highlighted in a letter sent to lawmakers on September 15 from the leaders of major industry groups, including the Personal Care Products Council and the Consumer Healthcare Products Association. In their correspondence, they expressed gratitude for legislative efforts surrounding the Modernization of Cosmetics Regulations Act of 2022 and reiterated their commitment to collaborating with Congress on a comprehensive and bipartisan national framework for cosmetics regulation.

In their letter, industry leaders emphasized that both the FDA and the personal care products industry strive to ensure the safety of cosmetics. They pointed out that the regulatory framework governing these products has not been updated since the Federal Food, Drug, and Cosmetic Act of 1938, and stressed the importance of modernizing regulations to ensure the FDA possesses the necessary authority and resources for effective oversight of the sector.

FDA Takes Action Against Companies Selling Misleading Cardiovascular Dietary Supplements

On November 17, the U.S. Food and Drug Administration (FDA) issued warning letters to seven companies accused of illegally marketing dietary supplements that falsely claimed to cure, treat, mitigate, or prevent cardiovascular diseases and related conditions. This decisive action underscores the FDA’s commitment to protecting consumers from misleading health claims.

The companies receiving these warning letters include Essential Elements (Scale Media Inc.), Calroy Health Sciences LLC, Iwi, BergaMet North America LLC, Healthy Trends Worldwide LLC (Golden After 50), Chambers’ Apothecary, and Anabolic Laboratories, LLC. These companies were found to be in violation of the Federal Food, Drug, and Cosmetic Act for their misleading marketing practices.

According to FDA regulations, any product marketed to diagnose, cure, treat, mitigate, or prevent disease is classified as a drug and is subject to the same rigorous standards as approved medications. Unlike FDA-approved drugs, the dietary supplements implicated in the warning letters have not been evaluated for efficacy, appropriate dosage, or potential interactions with other medications, raising significant safety concerns.

“Cardiovascular disease is the leading cause of death in the United States, making it imperative for the FDA to protect the public from products and companies that make unlawful claims,” stated Cara Welch, director of the Office of Dietary Supplement Programs within the FDA. “Consumers who rely on these misleading claims may forgo effective treatments from qualified healthcare providers, potentially endangering their health.”

The FDA has demanded that these companies respond within 15 working days, providing detailed plans on how they intend to address the violations or justification for their claims. Failure to comply may result in further legal actions, including product seizures and injunctions, reinforcing the seriousness of compliance with FDA regulations.

California Governor Rejects Bill to Limit Weight Loss Supplement Sales to Minors

California Governor Gavin Newsom has exercised his veto power over AB 1341, a proposed law that would have prohibited retailers from selling specific weight-loss dietary supplements to minors without a prescription or valid identification. This decision has sparked discussions about the safety and accessibility of dietary products for younger consumers.

The legislation aimed to restrict the sale, transfer, or distribution of dietary supplements designed for weight loss or over-the-counter diet pills to anyone under the age of 18, necessitating a prescription or ID for purchase. Additionally, it mandated that the California Department of Public Health (CDPH) compile a list of dietary supplements subject to these restrictions.

In a veto message dated September 29, Governor Newsom acknowledged the importance of the bill, stating that it raised a significant public health concern regarding the safety of diet and weight loss supplements, which can pose serious health risks. However, he expressed concerns regarding the feasibility of the CDPH evaluating every individual product for safety, as dietary supplements are not classified as drugs.

Governor Newsom has directed the CDPH to establish a working group dedicated to studying the complexities surrounding the sale of weight-loss supplements. Furthermore, he indicated that the department is prepared to collaborate with state legislators in future sessions to address age restrictions and other legislative measures that would ensure the responsible sale of dietary supplements without necessitating extensive pharmacological assessments.

Legal Challenges and Consumer Protection

Lawsuit Filed After NIH Study Links Hair-Straightening Products to Cancer

A consumer has filed a lawsuit against L’Oréal USA Inc., claiming that their hair-straightening products—including Motions, Organic Root Stimulator Olive Oil Relaxer, and Dark & Lovely—contain endocrine-disrupting chemicals (EDCs) that allegedly contributed to the plaintiff’s uterine cancer. This case, known as Mitchell v. L’Oréal USA Inc., was filed on October 21, 2022, in the Northern District of Illinois.

The plaintiff’s allegations suggest that phthalates, recognized as harmful EDCs that disrupt hormone production, are present in these hair products despite established links to various health risks. The plaintiff contends that her diagnosis of uterine cancer was directly attributable to the dangerous and defective nature of the products at the time of their sale and use, including the absence of adequate warnings regarding their potential risks. The lawsuit claims failure to warn, strict liability for design or manufacturing defects, fraud, negligence, and seeks damages along with coverage of legal fees.

The complaint references a study released by the National Institutes of Health on October 17, 2022, which reportedly concluded that women who frequently use hair-straightening products—specifically, those using them more than four times a year—were more than twice as likely to develop uterine cancer compared to non-users. The implications of this study have raised significant concerns among consumers regarding the safety of such cosmetic products.

However, some industry experts have raised questions about the methodology and conclusions of the NIH study. A representative from the Personal Care Products Council stated, “A fundamental principle of epidemiology is that association is not the same as causation; one does not necessarily lead to the other.” They emphasized that the observed correlation pertains to individuals who use hair-straightening products, rather than a direct link to specific ingredients, which were not comprehensively analyzed in the study.

Safety Concerns Raised Over ColourPop Eye Makeup Ingredients

A consumer has initiated a proposed class action lawsuit against ColourPop Cosmetics LLC, asserting that the company’s eye makeup products, including various eyeshadow palettes and eyeliners, contain dangerous color additives that are unsuitable for use around the delicate eye area. This case, Wilson v. ColourPop Cosmetics LLC, was filed on September 12, 2022, in the Northern District of California.

The plaintiff claims that over ten of the color additives utilized in ColourPop’s formulations have been deemed unsuitable and unapproved for cosmetic use near the eyes by the U.S. Food and Drug Administration. She contends that the disclaimer on ColourPop’s website does not adequately inform consumers about the potential dangers, stating that while these shades are “not intended for use in the immediate eye area,” they can be applied anywhere else on the face or body. This disclaimer is perceived as misleading by the plaintiff.

According to the complaint, this disclaimer fails to serve as a genuine safety warning and does not effectively communicate the risks associated with using these products near the eyes. The plaintiff argues that the language used in the disclaimer is not clear and could mislead consumers into believing the products are safe for eye application, thereby neglecting to provide proper guidance on safe usage.

As part of her claims, the plaintiff seeks damages, class certification, injunctive relief, and compensation for attorney’s fees based on alleged violations of California’s consumer protection laws, including fraud and breach of warranties.

FDA Takes Action on Misbranded and Adulterated Dietary Supplements

An Arizona-based dietary supplement manufacturer has entered into a consent decree with the U.S. Food and Drug Administration (FDA) following accusations of allowing its products to become adulterated and selling misbranded dietary supplements. The case, U.S. v. Global Vitality, Inc., was filed on October 12, 2022, in the District of Arizona.

The FDA’s consent decree and complaint against Global Vitality, operating under the name Enzyme Process International, stem from inspections conducted at the company’s facility in 2021. Investigators found substantial deviations from established good manufacturing practices for dietary supplements, including inadequate maintenance and cleaning of equipment and food-contact surfaces.

In addition to issues related to manufacturing practices, the FDA identified problems with the labeling of the company’s Enzyme Process-branded shark cartilage product. The labeling was deemed “false and misleading,” as it claimed the product contained freeze-dried shark cartilage without added ingredients, while in fact, it also contained magnesium stearate.

The FDA has previously warned Global Vitality about these ongoing violations, issuing a warning letter in January 2020 concerning the introduction of unapproved new drugs, misbranded drugs, and adulterated dietary supplements into interstate commerce. The consent decree mandates that Global Vitality hire independent experts to conduct thorough inspections, review product labeling, and ensure compliance with regulatory standards moving forward.

Consumer Lawsuit Challenges Misleading Claims on Dr. Squatch Shampoo

A proposed class action lawsuit has been filed against Dr. Squatch, alleging that the company’s labeling of its Men’s Natural Shampoo misleads consumers into believing the product is entirely natural, despite containing synthetic ingredients. The case, Fleming v. Dr. Squatch, LLC, was filed on September 8, 2022, in the Northern District of Illinois.

The plaintiff asserts that the shampoo, while marketed as “natural,” contains several synthetic substances such as glycerin, citric acid, fragrance, and decyl glucoside, which contradicts the claims made on its packaging. This discrepancy has raised significant concerns about the honesty of the product’s marketing and the potential for consumer deception.

Alleging violations of the Illinois Consumer Fraud and Deceptive Business Practices Act, as well as similar state consumer fraud statutes, the plaintiff seeks class certification, injunctive relief, damages, and reasonable attorney’s fees in response to the misleading marketing practices employed by Dr. Squatch.

Lawsuit Alleges Misleading Natural Flavor Claims in Drip Drop Beverages

A consumer has filed a lawsuit against Drip Drop Hydration Inc., claiming that the company misleads consumers regarding the nature of the ingredients used to flavor its rehydration drink mixes. The case, Helems v. Drip Drop Hydration Inc., was filed on September 20, 2022, in the Southern District of California. The plaintiff contends that the product packaging, which features images of fruit in water, falsely emphasizes the purported natural flavors of the beverages.

The complaint argues that by showcasing fruit images, Drip Drop implies that the products are flavored solely by the depicted fruits. However, the plaintiff asserts that this representation is misleading, as the actual flavoring comes from synthetic sources, specifically malic acid, which does not qualify as a ‘natural flavor’ under federal and state definitions.

The plaintiff claims that these misleading marketing practices violate California’s consumer protection statutes and seeks class certification, damages, injunctive relief, and reimbursement of attorney’s fees and costs as part of the legal proceedings against Drip Drop Hydration Inc.

Court Upholds Consumers’ Claims Against L’Oréal Regarding Collagen Misrepresentation

In a significant ruling, a federal court in New York has denied L’Oréal USA Inc.’s motion to dismiss a proposed class action lawsuit alleging that the company misleads consumers regarding the anti-aging benefits of its topical products containing collagen. This case, Lopez v. L’Oréal USA, Inc., was filed on September 27, 2022, in the Southern District of New York.

The plaintiffs in the case argue that L’Oréal marketed certain products as providing anti-aging effects due to the presence of collagen, despite being aware that the collagen used in these formulations does not penetrate the skin sufficiently to deliver the claimed benefits. This raises serious questions about the integrity of the marketing practices employed by L’Oréal.

The court determined that the key issue revolves around whether a reasonable consumer would interpret the term “collagen” on the label as being associated with skin benefits. The ruling indicates that the plaintiffs have provided sufficient grounds to argue that the term “collagen” implies benefits related to skin health and appearance.

The court noted that the product labeling lacks any disclaimers regarding the inability of collagen or related ingredients to penetrate the skin. Instead, the marketing language connects the products with the benefits of collagen, suggesting they can “smooth wrinkles” and “restore skin’s cushion,” which are claims that directly relate to reversing signs of aging.

8th Circuit Court Rules on Claims Against Memory Supplement Manufacturer

In a recent decision, the 8th Circuit Court ruled against a consumer’s claims that Natrol, LLC violated Missouri law by failing to disclose the retraction of clinical studies used to promote the benefits of its memory supplement. The case, Vitello v. Natrol, LLC, was decided on October 6, 2022.

The plaintiff had purchased Natrol’s Cognium supplement after being drawn to claims that it improved memory and concentration. After being diagnosed with attention-deficit disorder and ceasing her prescription medication for the product, the plaintiff reported no noticeable improvements in her condition.

Prior to her purchase, the packaging prominently featured assertions about significant improvements in memory and cognition based on nine clinical studies involving various age groups. However, the plaintiff later discovered that two of these studies had been retracted due to concerns over data manipulation and fraud.

Natrol sought summary judgment, which was granted by the district court on the grounds that the plaintiff failed to establish a clear loss attributable to the company’s actions. The 8th Circuit upheld this decision, noting that the product’s labeling explicitly stated it was “not intended to” substitute for prescription treatments, which undermined the plaintiff’s claims.

Consumer Files Lawsuit Against REBBL Over Protein Content Misrepresentation

In a proposed class action, a California woman has accused REBBL of misleading consumers regarding the protein content in its Plant Based Elixir beverages. The case, Roffman v. REBBL, Inc., was filed on September 16, 2022, in the Northern District of California.

The lawsuit asserts that REBBL’s packaging prominently claims each beverage contains 16 grams of protein. However, the plaintiff argues that the U.S. Food and Drug Administration (FDA) mandates that food manufacturers calculate the corrected amount of protein based on the quality of the protein source, which REBBL allegedly failed to do.

According to the complaint, consumers have a reasonable expectation that the products will deliver the full amount of protein claimed on the label. The plaintiff contends that due to the low quality of the protein in REBBL’s beverages, the actual nutritional value may be as low as half of the advertised amount. This discrepancy raises significant concerns about the validity of the product’s marketing.

The plaintiff is pursuing claims under California’s Consumers Legal Remedies Act and False Advertising Law, seeking class certification, injunctive relief, damages, restitution, and reasonable attorney’s fees for the alleged misrepresentations regarding protein content.