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The Food and Drug Administration (FDA) continued to exercise its
increasingly conservative approach to cosmetics claims by issuing
numerous warning letters to cosmetics companies and continuing to
carefully scrutinize imported products. The FDA's agenda
demonstrates that regulating cosmetics has become an increasingly
important priority for the agency.
The FDA was particularly concerned with claims for cosmetic
products that indicated that the product could affect a structure
or function of the human body or treat, prevent, or mitigate a
disease or its symptoms, as these types of claims indicated that
the product was a drug rather than a cosmetic. The FDA issued
several warning letters to major cosmetics manufacturers for claims
that products could "reduce visible redness," "treat
dark spots and discolorations," "change the anatomy of a
wrinkle," "provid[e] noticeable lift," and
"stimulate collagen production." In the warning letters,
the FDA indicated that such claims rendered the products new and
unapproved drugs. Companies reacted to the FDA's actions by
reviewing and examining product claims.
The FDA also detained significant numbers of cosmetic shipments
that it believed were not in compliance with the law —
particularly those containing claims that a product could remove
wrinkles, reduce hyperpigmentation, or prevent the appearance of
dark spots. In addition, the FDA focused on detaining products that
it believed might contain illegal color additives that were unsafe
for use in cosmetics products.
To enhance the FDA's authority in the cosmetics area, a bill
was introduced that, if enacted, would require cosmetics companies
to register their facilities with the FDA, submit ingredient
statements, and allow the FDA to prohibit a cosmetic's
distribution if the FDA determined that the product might cause
serious health consequences.
Looking Ahead
Properly vet all new product packaging, advertising, and
websites to ensure compliance with FDA regulations and, in light of
increased scrutiny, review already existing packaging and claims
through a more conservative lens.
When importing FDA-regulated products, companies should
anticipate the FDA's increased scrutiny.
Keep an eye out for new Congressional bills related to
cosmetics.
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