FDA Aggressively Detains and Refuses Imported Cosmetics with Non-Permitted Color Additives, According to FDAImports.com

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FDA continues to analyze and scrutinize imported cosmetics for containing non-permitted color additives, especially cosmetics intended for use around the eyes.

FDA Cosmetics and Color Additives Chart

FDA Cosmetics and Color Additives Chart

A manufacturer or importer should have its cosmetic formulations and labeling reviewed to ensure it only uses permissible color additives as well as review the label for compliance by ensuring the ingredients are named properly.

FDA continues to analyze and scrutinize imported cosmetics for containing non-permitted color additives, especially cosmetics intended for use around the eyes. In June 2011, non-permitted color additives accounted for one-third of all imported cosmetic refusals by FDA. Over one-half of those import refusals were eye products. These 2011 percentages match FDA’s refusals rates in June 2010, according to Benjamin England and the team at FDAImports.com

These numbers should not surprise cosmetic manufacturers and importers. FDA’s Compliance Program Guidance Manual specifies that FDA investigators should inspect for non-permitted color additives in cosmetics, particularly those intended for the eye area. However, these statistics indicate that many in the industry fail to verify compliance with US law. Cosmetic manufacturers and importers make several common mistakes concerning color additives. At best, these mistakes can cause supply-chain delays that occur while rectifying an FDA detention. At worst they can lead to import refusals and inclusion on Import Alert.

Common Cosmetic Importing Mistakes

The first common mistake that many manufacturers make is using a color additive that is approved in one country, but is not FDA-approved. For example, in Europe a cosmetic not applied on mucous membranes can include CI 11680 (Pigment Yellow 1). However in the United States, a cosmetic cannot include CI 11680 at all.

The second most common mistake is when the cosmetic includes an FDA-approved color additive, but that color additive is not approved for that specific product category. For example, D&C Red No.6 is approved for general use (including lips), but not for use around the eyes. Therefore, a lipstick may include Red 6, but an eye shadow cannot.

These first two mistakes are costly formulation errors that require the importer to either export or destroy the cosmetic. Even more damaging, FDA may place the manufacturer on Import Alert 53-06 (“Detention Without Physical Examination of Cosmetics Containing Illegal Colors”). According to FDA’s Regulatory Procedures Manual, a single violation provides the basis for adding a manufacturer to Import Alert 53-06. While on Import Alert, FDA will automatically detain all future shipments and the importer must affirmatively demonstrate compliance for each product affected by the alert.

The third most common mistake of importing cosmetics occurs when the cosmetic’s label declares the color additive according to a name other than the FDA-established name. For example, the label only states the “CI” number, instead of the name FDA has established for the color.

Fourth, the cosmetic includes non-color additives or unapproved color additives in a “May Contain” statement on the label. This is a common way of identifying all kinds of cosmetic ingredients in other countries, but it is carefully regulated in the US. FDA assumes everything added to a “May Contain” statement is a color additive, which often results in expensive FDA import detentions.

These last two mistakes are labeling errors and FDA frequently requires the importer to relabel the cosmetic to rectify the error. Sometimes it is possible to convince FDA to release the shipment without relabeling it the only mistakes are in regard to the label. In either case, the importer suffers supply-chain delays and strained business relationships, plus any costs associated with relabeling if necessary.

However, a foreign cosmetic manufacturer or US importer can avoid FDA detention, FDA refusal, and possible inclusion on an FDA Import Alert list by investing in simple regulatory compliance work at the beginning. A manufacturer or importer should have its cosmetic formulations and labeling reviewed to ensure it only uses permissible color additives as well as review the label for compliance by ensuring the ingredients are named properly. Manufacturers should also pay special attention to the “May Contain” statement as it often contains color additive information that can go overlooked.

These simple, but critical steps, can save manufacturers and importer from untold headaches and thousands of wasted dollars down the road.

SOURCES
http://www.fda.gov/ICECI/ComplianceManuals/ComplianceProgramManual/default.htm
http://www.fda.gov/forindustry/importprogram/importrefusals/default.htm

Benjamin L. England is a former 17-year veteran of the FDA and served as the Regulatory Counsel to the Associate Commissioner for Regulatory Affairs. Currently he is founder and CEO of FDAImports.com, LLC, a firm of consultants and affiliated attorneys practicing at the intersections of complex administrative law and regulations that impact international traders in highly regulated commodities.

For more information contact Benjamin L. England and the FDAImports.com team at http://www.fdaimports.com, call (410) 740-3403 or contact Jon Barnes at jrbarnes(at)fdaimports(dot)com.

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