Import Alert 53-03

(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

Import Alert # 53-03
Published Date: 12/10/2020
Type: DWPE

Import Alert Name:

"Oral Tanning Tablets"

Reason for Alert:

Import Alert #53-03 originally issued in 1981 in response to a number of inquiries concerning the status of oral tanning tablets. Recently inquires about these tablets have surfaced again. These products are classified as cosmetics. Canthaxanthin, the major ingredient, is a color additive which has not been approved by the agency for this or any other cosmetic use. Therefore this product contains an unsafe color additive and is deemed adulterated and subject to regulatory action.

Guidance:

Districts may detain, without physical examination, all shipments of oral tanning tablets that contain canthaxanthin from all manufacturers.



For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Office of Regulatory Science at oraorsprivatelabimportalerts@fda.hhs.gov .



All requests for removal from detention without physical examination should be address to DIOP 301-796-0356.

Product Description:

Oral Tanning tablets which contain the ingredient canthaxanthin (Alternate names: C.I. 40850 Canthaxanthin (C.I. Food Orange 8)

Charge:

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive (canthaxanthin) which is unsafe within the meaning of Section 706(a) [Adulteration, Section 601(e)]."

Countries

MULTIPLE COUNTRIES (PODS ONLY)

  • (53 M L - 99) Other Suntan Preparations (not Sunscreen), N.E.C., Tablets
    Desc: Oral tanning tablets which contain canthaxanthin
    Problems:40850-CANTHAXANTHIN (C.I. FOOD ORANGE 8);