Slack formulation and labeling of color additives can lead to added costs and stress

By Andrew McDougall

- Last updated on GMT

Related tags Import Fda

Slack formulation and labeling of color additives can lead to added costs and stress
Investing in having formulations and labels reviewed to ensure they only use permissible color additives, as well as ensuring ingredients are named correctly on the label can save cosmetics manufacturers and importers a lot of time, stress and money, according to a private US consulting firm.

In June 2011, non-permitted color additives accounted for one third of all imported cosmetic refusals by the US Food and Drug Administration (FDA). Over one half of those import refusals were eye products, according to Benjamin England and the team at

Whilst these statistics will not come as a shock to the industry, they indicate that many cosmetics manufacturers and importers fail to verify compliance with US law and make several common mistakes concerning color additives.

On the back of this, has stated that foreign cosmetic manufacturers or US importers can avoid detention, refusal, and possible inclusion on an FDA Import Alert list by investing in simple regulatory compliance work at the beginning.

Formulation errors

The first common mistake that many manufacturers make is using a color additive that is approved in one country, but is not FDA-approved.

Another common mistake is when the cosmetic includes an FDA-approved color additive, but that is not approved for that specific product category, such as a color that is suitable for use in lip products but not for use around the eyes, a particularly common mistake.

These mistakes are costly formulation errors that require the importer to either export or destroy the cosmetic, and possibly get placed on an FDA Import Alert.

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.

Common labeling mistakes

One of the most common mistakes in labeling is when the cosmetic’s label declares the color additive according to a name other than that established by the FDA.

Another labeling mistake is when the cosmetic includes non-color additives or unapproved color additives in a “May Contain” statement on the label.

FDA states this is a common way of identifying all kinds of cosmetic ingredients in other countries, but it is carefully regulated in the US. Thus it assumes everything added to a “May Contain” statement is a color additive, which often results in expensive FDA import detentions.

It also urges that manufacturers pay special attention to “May Contain” statements as they often contain color additive information that can go overlooked.

These mistakes frequently require the importer to re-label the cosmetic to rectify the error, although it is sometimes possible to release the shipment without relabeling if the mistakes are only in regard to the label. Either way though, the importer suffers supply-chain delays as well as extra costs and stress.

Related topics Regulation & Safety

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