Foshan Miwei Cosmetics Co., Ltd.
FDA issued a warning letter to Foshan Miwei Cosmetics Co., Ltd. (China) for manufacturing OTC sunscreen drug products — Trust MD SPF 30 Stem Cell Face Cream and inBlair Elevate SPF 15 Moisturizer — that are unapproved new drugs and misbranded under the FD&C Act, in addition to multiple CGMP violations. The products' labeling made pharmacological claims for ingredients such as plant-based stem cells, sodium hyaluronate, vitamins B/C, and vitamin B3 (e.g., collagen promotion, cell repair, reducing hyperpigmentation/inflammation) that rendered them unapproved drugs not conforming to the OTC sunscreen monograph M020. FDA had already placed the firm on Import Alert 66-40 as of February 13, 2026, and the letter demands corrective action within 15 working days or continued refusal of admission of the firm's products into the United States.
Flagged claims (8)
PLANT-BASED STEM CELLS: Improves texture, fine lines, and skin tone by restoring cells natural balance pH. Promotes collagen production
SPF 15…Drug Facts… Use… Helps prevent sunburn…To aide in the protection against harmful UV rays…VITAMIN B3 can reduce hyperpigmentation, & inflammation
To aide in the protection against harmful UV rays
C…promotes collagen production
B5 binds moisture to skin cells, which plumps and firms the skin, and erases fine lines
VITAMIN B3 can reduce hyperpigmentation, & inflammation
SPF 30…Drug Facts…Uses…Helps prevent sunburn…PLANT-BASED STEM CELLS: Improves texture, fine lines, and skin tone by restoring cells natural balance pH. Promotes collagen production…SODIUM HYALURONATE:…It repairs and protects youthful skin cells...Vitamins B5, C, …B5 binds moisture to skin cells, which plumps and firms the skin, and erases fine lines…C…promotes collagen production…
SODIUM HYALURONATE:…It repairs and protects youthful skin cells
Required actions (5)
FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on February 13, 2026.
After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence.
Correct any violations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP.
Failure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at Foshan Miwei Cosmetics Co., Ltd., 801 & 802, Building 9, Baofa Jewellery Industry Centre, No. 1, Feicui Road, Yang'e Village Committee, Lunjiao Town, Shunde District, Foshan City, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3).
you should engage a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm's compliance status with FDA.
Does your site contain similar claims?
The free site audit scans your site against every entry in this Atlas. Most nutrition / supplements sites match 3-6 patterns.
Run my free site audit