FDA Flags Color Additive, SPF and Contaminant Offenses, Urges 'Recall Readiness'

Within the past several months, the U.S. Food and Drug Administration (FDA) has reported six voluntary recalls by cosmetic firms for a glitter eye shadow containing the impermissible color additive Rhodamine B; a serum and product kit claiming SPF on the label without actual SPF; and various products cited for mold, bacteria or metal shaving contaminants. In relation, the agency provided a final guidance on voluntary recalls and urged companies to be "recall ready" to protect public health.

It is critical that all companies in the supply chain are 'recall ready' to ensure appropriate actions are taken swiftly across the distribution channels to best protect public health and the integrity of the supply chain."

Ximenia Oil

On Sept. 23, 2021, a recall was initiated by DLG Naturals, Inc., of Janesville, WI, for ximenia oil (lot 25207-80321-10) which was out of specification for mold.

Kroger Comforts Cornstarch Baby Powder

On Nov. 15, 2021, a recall was initiated by Vi-Jon, Inc., of Smyrna, TN, for Kroger Comforts Cornstarch Baby Powder (lot 0527189; product number 0-41260-38021-1; best by 03/2024), 1 lb 6 oz, white plastic bottle with natural color sifter cap, 6 bottles per case, for failing quality standards. Small metal shaving contaminants were identified. The product was distributed in Indiana, Oregon, Ohio, Pennsylvania, Texas, Arkansas, California and Illinois.

Dollar General Gentle Steps Baby Lotion

On Nov. 15, 2021, another recall was initiated by Vi-Jon, Inc., of Smyrna, TN, for Dollar General Gentle Steps Baby Lotion (lot 0512866; product number 0-72785-13876-6; best by 02/2024) 16.9 fl oz, pink oval plastic bottle with a milk white disc cap, 24 bottles per case, for failing quality standards. The product tested positive for E. coli. The lotion was distributed in Indiana, Oregon, Ohio, Pennsylvania, Texas, Arkansas, California and Illinois.

Wal-Mart Equate Dry Mouth Oral Rinse

On Nov. 15, 2021, another recall was initiated by Vi-Jon, Inc., of Smyrna, TN, for Wal-Mart Equate Dry Mouth Oral Rinse (lot 0430552; product numbers 6-81131-00278-3 (domestic) and 6-28915-58212-3 (Canada); best by 03/2022) packaged in a white oblong plastic bottle with a white cap, 33.8 fl oz, 4 bottles per case, for failing sterility standards. The product tested positive for bacterial contamination. The product was distributed in Ontario, Canada.

Calm and Renew Serum, and Beautiful Energy Starter Kit

On Jan. 20, 2022, Cynosure LLC, of Westford, MA, issued a recall for Calm and Renew Serum, and the Beautiful Energy Starter Kit containing the serum (serum: lot/unit numbers LR011J22C; expiration date(s) or use by date(s) or expected shelf life of product: 9/1/2024; UPC codes 00841494106973; starter kit PN 921-7054-120) for cosmetic inner packaging listing SPF when the product has no SPF. The products were distributed in: Alaska, Alabama, Arkansas, Arizona, California, Florida, Georgia, Hawaii, Idaho, Illinois, Kentucky, Massachusetts, Maryland, Michigan, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, New York, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Washington state. 

Glitter Eye Shadow

On Jan. 20, 2022, Almar Sales Co., Inc., of New York, NY, recalled Glitter Eye Shadow (GG10989PC; UPC 0 24576 86042 4; YC-2006-5798), 1 pc, net wt 0.6 oz (17 g), for containing undeclared Rhodamine B, an impermissible color additive. The product was provided to one corporate customer located in New Jersey and further distributed nationwide.

Recall Readiness

The FDA also issued a finalized guidance to help companies prepare to quickly and effectively remove violative products from the market. The guidance describes steps companies should take before a recall is necessary, as well as how to develop recall policies and procedures that include training, planning and record-keeping to reduce the time a recalled product is on the market and thus limit the public’s exposure to risk.

“Voluntary recalls continue to be the fastest, most effective way for a company to correct or remove violative and potentially harmful products from the market to help keep consumers safe,” said Associate Commissioner of Regulatory Affairs Judith McMeekin, Pharm. D. “It is critical that all companies in the supply chain are 'recall ready' to ensure appropriate actions are taken swiftly across the distribution channels to best protect public health and the integrity of the supply chain. We will continue to work with companies to improve their recall procedures and minimize Americans’ exposure to potentially harmful products.”