News Brief: FDA Issues Warning Letters to Companies Selling Unapproved Over-The-Counter Skin-Lightening Drug Products

FDA Issues Warning Letters to Companies Selling Unapproved Over-The-Counter Skin-Lightening Drug Products

On April 19, 2022, the Food and Drug Administration (FDA) announced that the agency had issued warning letters to 12 companies for selling illegal over-the-counter (OTC) drug products intended for skin lightening.[1] The warning letters were issued on April 13, 2022, and stated that the OTC skin-lightening products, which contained the active drug ingredient hydroquinone, were unapproved drugs and were “not generally recognized as safe and effective.” Marketing of these products without FDA approval of a new drug application therefore was prohibited under the Food, Drug, and Cosmetic Act.

The FDA noted that it had received reports of serious adverse effects, including skin rashes, facial swelling and ochronosis (discoloration of skin), due to use of skin-lightening products containing hydroquinone. The agency advised consumers not to use these OTC skin-lightening products due to the potential for harm, including permanent skin discoloration.

The agency emphasized that there are no FDA-approved or otherwise legally marketed OTC skin-lightening products. There is one prescription product containing hydroquinone marketed under the brand name TRI-LUMA that is approved by the FDA for the short-term treatment of dark spots associated with moderate-to-severe melasma of the face — a skin condition characterized by tan, brown or brown-grey patches that typically occur on the face, most often in women who are pregnant or using oral contraceptives.[2] This prescription product should only be used under the supervision of a licensed health care professional.

The 12 companies that received warning letters for marketing illegal OTC skin-lightening products were: AMBI Enterprises;[3] Clinical Formula LLC;[4] Dr. Thomas Balshi/Intilight;[5] Elements Brands Inc.;[6] Genomma Lab USA;[7] M&M Beauty and Wellness, LLC;[8] Neoteric Cosmetics, Incorporated/Scott’s Liquid Gold, Inc.;[9] Skin Authority, LLC;[10] Skin Pro;[11] Skin PS Brands;[12] True Earth Health Products, LLC;[13] and Ultimark Products.[14]

Consumers should talk to a health care professional about treatment options for melasma or other age or dark spots on the skin.

References

[1] Food and Drug Administration. FDA works to protect consumers from potentially harmful OTC skin lightening products. April 19, 2022. https://www.fda.gov/drugs/drug-safety-and-availability/fda-works-protect-consumers-potentially-harmful-otc-skin-lightening-products. Accessed April 25, 2022.

[2] Torborg L. Mayo Clinic Q and A: Treating melasma. November 19, 2019. https://newsnetwork.mayoclinic.org/discussion/mayo-clinic-q-and-a-treating-melasma/. Accessed April 25, 2022.

[3] Food and Drug Administration. Warning letter to AMBI Enterprises LLC. April 13, 2022. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ambi-enterprises-llc-628367-04132022. Accessed April 25, 2022.

[4] Food and Drug Administration. Warning letter to Clinical Formula LLC. April 13, 2022. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/clinical-formula-llc-628372-04132022. Accessed April 25, 2022.

[5] Food and Drug Administration. Warning letter to Dr. Thomas Balshi/Intilight. April 13, 2022. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dr-thomas-balshiintilight-628402-04132022. Accessed April 25, 2022.

[6] Food and Drug Administration. Warning letter to Elements Brands Inc. April 13, 2022. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/elements-brands-inc-628380-04132022. Accessed April 25, 2022.

[7] Food and Drug Administration. Warning letter to Genomma Lab USA, Inc. April 13, 2022. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/genomma-lab-usa-inc-628381-04132022. Accessed April 25, 2022.

[8] Food and Drug Administration. Warning letter to M & M Beauty and Wellness, LLC. April 13, 2022. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/m-m-beauty-and-wellness-llc-628392-04132022. Accessed April 25, 2022.

[9] Food and Drug Administration. Warning letter to Neoteric Cosmetics, Incorporated/Scott's Liquid Gold, Inc. April 13, 2022. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/neoteric-cosmetics-incorporatedscotts-liquid-gold-inc-628399-04132022. Accessed April 25, 2022.

[10] Food and Drug Administration. Warning letter to Skin Authority, LLC. April 13, 2022. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/skin-authority-llc-628385-04132022. Accessed April 25, 2022.

[11] Food and Drug Administration. Warning letter to SkinPro. April 13, 2022. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/skinpro-628398-04132022. Accessed April 25, 2022.

[12] Food and Drug Administration. Warning letter to Skin PS Brands. April 13, 2022. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/skin-ps-brands-628396-04132022. Accessed April 25, 2022.

[13] Food and Drug Administration. Warning letter to True Earth Health Products, LLC. April 13, 2022. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/true-earth-health-products-llc-628383-04132022. Accessed April 25, 2022.

[14] Food and Drug Administration. Warning letter to Ultimark Products. April 13, 2022. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ultimark-products-628389-04132022. Accessed April 25, 2022.