This briefing of legal infractions in beauty includes 18 product citations in Europe for fragrance allergens and prohibited substances; J&J's $1.1 billion increased offer to settle talc/cancer lawsuits; a water-based tattoo pigment recalled for microbe contamination in the U.S.; and a dropped class action suit against Coppertone facial sunscreens. Following is a wrap-up.
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This briefing of legal infractions in beauty includes 18 product citations in Europe for fragrance allergens and prohibited substances; J&J's $1.1 billion increased offer to settle talc/cancer lawsuits; a water-based tattoo pigment recalled for microbe contamination in the U.S.; and a dropped class action suit against Coppertone facial sunscreens. Following is a wrap-up.
18 Allergen, Prohibited Ingredient Citations by the EC
According to the European Commission's (EC's) SafetyGate rapid alert system for dangerous non-food products, the following cosmetic products have been cited as of Sept.1, 2024 for fragrance allergens and prohibited ingredients.
- Adidas Aftershave, 100 mL. Product sold online. According to the list of ingredients, the product contains 2-(4-tert-butylbenzyl) propionaldehyde (BMHCA), which is prohibited in cosmetic products. BMHCA may harm the reproductive system, may harm the health of the unborn child and may cause skin sensitization. Batch numbers: 0038, 9231, 9338, 9352.
- Black Opium Eau de parfum in an ash-colored, rough-textured glass bottle with a plastic cap, 85 mL. Manufacturing date: 02/06/2023, Expiry date: 01/06/2028. The product contains d-limonene, linalool, benzyl alcohol, citronellol, geraniol, cinnamyl alcohol, hexyl cinnamal, benzyl benzoate and benzyl salicylate but their presence is not indicated in the list of ingredients. Consumers are not aware of their presence and may suffer allergic reactions or skin sensitization.
- Yves Saint Laurent Eau de parfum. Manufacturing date: 2019/03/18, Expiry date: 2024/03/17. The perfume contains allergenic fragrances linalool, hydroxycitronellal, cinnamyl alcohol, hexyl cinnamal and benzyl salicylate. These substances, which can induce allergic reactions and sensitization, are not indicated in the list of ingredients so consumers are not aware of their presence. Batch number: 190318-7.
- Black Opium Eau de parfum, natural spray, 85 mL. Manufacturing date: 2022/07/02, Expiry date: 2027/07/0. According to the list of ingredients, the product contains 2-(4-tertbutylbenzyl) propionaldehyde (BMHCA), which is prohibited in cosmetic products. BMHCA can damage the reproductive system, harm fetal health and cause skin sensitization. Moreover, the perfume contains the allergenic fragrances d-limonene, linalool, benzyl alcohol, citronellol, geraniol, cinnamyl alcohol, farnesol, hexyl cinnamal and benzyl salicylate. These substances, which can induce allergic reactions and sensitization, are not indicated in the list of ingredients so consumers are not aware of their presence. Batch number: 220702-9.
- Black Opium Eau de parfum, 85 mL. Manufacturing date: 2022/12/30, Expiry date: 2027/12/29. The perfume contains allergenic fragrances d-limonene, linalool, benzyl alcohol, citronellol, geraniol, hydroxycitronellal, cinnamyl alcohol, hexyl cinnamal and benzyl salicylate. These substances, which can induce allergic reactions and sensitization, are not indicated in the list of ingredients so consumers are not aware of their presence.
- Black Opium, Eau de parfum, spray, 85 mL. Manufacturing date: 2022/06/21, Expiry date: 2027/06/20. The perfume contains allergenic fragrances d-limonene, linalool, benzyl alcohol, citronellol, geraniol, hydroxycitronellal, cinnamyl alcohol, hexyl cinnamal and benzyl salicylate. These substances, which can induce allergic reactions and sensitization, are not indicated in the list of ingredients so consumers are not aware of their presence. Batch number: 220621-1.
- Gordano Parfums, Eau de toilette, intended for men, 50 mL. According to the list of ingredients, the product contains 2-(4-tert-butylbenzyl)propionaldehyde (BMHCA), which is prohibited in cosmetic products. BMHCA can damage the reproductive system, may harm the health of the unborn child and may cause skin sensitization. Batch number: 01112017.
- Rozino face serum with hyaluronic acid, 30 mL. Product sold online. The product contains 2-(4-tert-butylbenzyl) propionaldehyde (BMHCA), which is prohibited in cosmetic products. BMHCA may harm the reproductive system, may harm the health of the unborn child and may cause skin sensitization. Batch number: YM2576.
- Wats Élysée hair coloring mousse. According to the list of ingredients, the product contains 2-(4-tert-butylbenzyl) propionaldehyde (BMHCA), which is prohibited in cosmetic products. BMHCA may harm the reproductive system, may harm the health of the unborn child and may cause skin sensitization. Batch number: 03268.
- Wats Élysée hair coloring mousse. According to the list of ingredients, the product contains 2-(4-tert-butylbenzyl) propionaldehyde (BMHCA), which is prohibited in cosmetic products. BMHCA may harm the reproductive system, may harm the health of the unborn child and may cause skin sensitization. Batch number: 02218.
- Wats Élysée hair coloring mousse. According to the list of ingredients, the product contains 2-(4-tert-butylbenzyl)propionaldehyde (BMHCA), which is prohibited in cosmetic products. BMHCA may harm the reproductive system, may harm the health of the unborn child and may cause skin sensitization. Batch number: 04129.
- Wats Élysée hair coloring mousse. According to the list of ingredients, the product contains 2-(4-tert-butylbenzyl) propionaldehyde (BMHCA), which is prohibited in cosmetic products. BMHCA may harm the reproductive system, may harm the health of the unborn child and may cause skin sensitization. Batch numbers: 01038 and 02158.
- Teeth whitening set (unbranded) containing: instructions and a color chart, a lamp, a mouth tray, 10 plastic syringes (transparent with a blue plunger) and 10 transparent plastic syringe nozzles. Product sold online. The product has an excessive concentration of hydrogen peroxide as a bleaching substance (measured value: 0.8% by weight). Hydrogen peroxide is harmful if swallowed and it can also cause irritation and ulcers when in contact with skin or mucous membranes. Batch number: 2023103101A.
- WAYI set of six 7.5 mL glitter gel nail polishes. Product sold online. The product contains 2-hydroxyethyl methacrylate (HEMA) (measured value: 51.2% by weight) and hydroquinone methylether (mequinol), which are prohibited in nail products for consumer use. HEMA causes serious eye irritation, skin irritation and may cause allergic skin reaction. Mequinol is harmful if swallowed, causes serious eye irritation and may cause allergic skin reaction. Batch number: 20240202.
- JFENZI Eau de parfum, intended for women, 100 mL. According to the list of ingredients, the product contains 2-(4-tert-butylbenzyl) propionaldehyde (BMHCA), which is prohibited in cosmetic products. BMHCA may harm the reproductive system, may harm the health of the unborn child and may cause skin sensitization. Batch number: W0823 45530818.
- Rodis light brown cream, perfumed, 500 mL. Best-before date 07/2028. The product contains hydroquinone (measured value up to 8.1%), which is forbidden in this cosmetic product. Hydroquinone may cause an allergic skin reaction and causes serious eye damage. Batch number: 23-1001-01.
- Floppy wet wipes, intended for cleaning and moisturizing the skin, 70 pieces. According to the list of ingredients, the product contains 2-(4-tert-butylbenzyl) propionaldehyde (BMHCA), which is prohibited in cosmetic products. BMHCA may harm the reproductive system, may harm the health of the unborn child and may cause skin sensitization. Batch number: 3056.
- Sulsena Anti-dandruff paste. According to the list of ingredients the product contains selenium disulfide which is prohibited in certain cosmetic products. Selenium disulfide may harm the reproductive system, may harm the health of the unborn child and may cause skin sensitization.
J&J Ups the Talc/Cancer Settlement Offer by $1.1 B
According to Reuters, Johnson & Johnson (J&J) has added $1.1 billion to its $8 billion offer (net $6.75 billion, present value) to settle tens of thousands of lawsuits alleging the company's talc-containing baby powder was tainted with asbestos, causing cancer in users.
Per the source, J&J reported on Sept. 4, 2024, that the plaintiffs' lawyer representing 12,000 clients agreed to recommend the settlement offer to them, adding to support already received from other claimants.
In a statement cited by Fiercepharma, Allen Smith, Esq., of The Smith Law Firm PLLC, representing the plaintiffs, said, “As the lawyer who started this litigation and tried the most cases, I feel strongly that the terms being offered to talc claimants are fair, and that this is the best and most realistic option available for claimants to recover for their claims in a timely manner. ...
"The opposition to this Plan has no meaningful alternative proposal for getting their claimants a better recovery on any sort of realistic timeline, and therefore, any opposition should cease. Our clients deserve fair and adequate compensation now, and my agreement with Johnson & Johnson provides them with that. I will be recommending this proposal to each of my clients.”
J&J reported the settlement and anticipated bankruptcy plan could be approved by the end of this month (September 2024).
Sierra Stain Recalls Contaminated Bloodline Brand Tattoo Pigments
The U.S. Food and Drug Administration (FDA) reported on Aug. 24, 2024, that Sierra Stain LLC of Carson City, Nevada, recalled three of its Bloodline brand water-based tattoo pigments due to high microorganism concentrations. Per the company, the contaminations present a health concern to consumers. The recall was initiated after the recalling firm became aware of the results of the samples collected and analyzed by FDA, which tested positive for multiple microorganisms.
The three products include:
- Bloodline 1/2 oz/15 mL in Carolina Blue; Batch #1 Lot BL23; Manufactured 07/01/23; Expires 07/01/26. Microorganisms identified included: Citrobacter braakii, Citrobacter farmer, Pseudomonas fluorescens, Achromobacter xylosoxidans, Ochrobactrum anthropic and Cupriavidus pauculus;
- Bloodline 1oz/30 mL in All Purpose Black; Batch #1 Lot BL23; Manufactured 07/01/23; Expires 07/01/26. Microorganism identified: Acetobacter senegalensis; and
- Bloodline 1/2 oz/15 mL in UV China Pink; Batch #1 Lot SC23; Manufactured 06/23; Expires 06/26. Microorganism identified: Curtobacterium citreum/pusillum.
Commonly reported symptoms of tattoo ink-associated infections include the appearance of rashes or lesions consisting of red papules solely in areas where the contaminated ink has been applied. Some tattoo infections can result in permanent scarring. Symptoms can be difficult to recognize, as other conditions (e.g. allergic reactions) may also present with similar findings.
Coppertone Facial Sunscreen Class Action Suit Dropped
Finally, according to Top Class Actions, consumers dropped a class action suit brought against Beiersdorf for "deceptively" labeling its Face 50 Sports Mineral sunscreen. The consumers alleged the product was no different than other sunscreens but was marketed specifically for the face in smaller, more expensive bottles. The case was reportedly dismissed without prejudice on Aug. 22, 2024; no potential settlement was mentioned, per Top Class Actions.