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FDA Issues Warnings for Cosmetics, Website Claims

August 20, 2015 | Contact Author | By: Nicole Urbanowicz
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Keywords: FDA | warning | letter | lipstick | skin care

Abstract: The FDA has taken recent compliance actions by issuing warning letters for cosmetics claims and unapproved ingredients.

The U.S. Food and Drug Administration (FDA) has taken recent compliance actions by issuing warning letters in July for violations of the Federal Food, Drug, and Cosmetic Act such as misleading claims and using color additives that aren't permitted for use in externally applied cosmetics.

The FDA issued a warning letter on July 29 concerning Lime Crime Velvetines Liquid Matte Lipstick (red velvet), saying that specifically, according to its product label, “it contains ferric ferrocyanide and ultramarines, which are only permitted for use in coloring externally applied cosmetics as prescribed in 21 CFR § 73.2299 and 21 CFR § 73.2725, respectively.”

Under section 721(a), a color additive is unsafe unless it is used in conformity with a regulation listing the additive for such use.

"Velvetines Liquid Matte Lipstick (red velvet) is an adulterated cosmetic because it bears or contains a color additive which is unsafe within the meaning of section 721(a)," the FDA said.

In a separate letter dated July 13, Golden Caviar Skin Care was issued a warning for claims on its website that indicated several products are intended for use in the cure, mitigation, treatment, or prevention of disease and/or are intended to affect the structure or any function of the human body, rendering them drugs under the Act.

The FDA cited Golden Caviar Skin Care’s Alpha Arbutin Cream (Whitening Cream), Bio Whitening and Caviar Lifting & Firming Serum with Zinc, Heal & Conceal and Redness Calming Serum as examples due to the following claims that had been listed on its website:

Alpha Arbutin Cream (Whitening Cream)

• “[H]elp get rid of dead skin…”

• “Reduces and prevents hyper-pigmentation…”

• “GREAT for reducing acne and acne scars!”

Bio Whitening

• “[H]elps to stop the formation of melanin pigment…”

• “[H]elp to exfoliate dark surface cells…”

• “Lightens skin Blocks and inhibits tyrosinase activity Limits melanin production Reduces redness (erythema).”

Caviar Lifting & Firming Serum with Zinc

• “It helps repair damaged tissues and heal wounds. Great for anyone wanting to do away with old acne scars or suffering from Rosacea.....We have found the solution.”

On the FAQ Page:

• “The most effective products for skin elasticity and wrinkles are found in our Caviar Lifting Serum. “Mini Botox in a Bottle”

Heal & Conceal

• “[A] natural antiseptic and antibacterial…”

• “[E]nhance the healing process by reducing inflammation…” Redness Calming Serum

• “[A]nti-inflammatory properties”

• “[G]reat for those with psoriasis.”

The FDA stated: “ … these products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are new drugs as defined in section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.”

Furthermore, among the products cited, the company’s skin care product Caviar Lifting & Firming Serum with Zinc, was cited by the FDA as “offered for a condition that is not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use this drug safely for their intended purposes. Thus, these drugs are misbranded within the meaning of section 502(f)(1) of the Act, in that the labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)]. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].”

In addition, the FDA said the company’s Golden Caviar products “are misbranded within the meaning of section 502(a) of the Act [21 U.S.C. § 352(a)] in that the labeling is false and misleading in any particular.”

The FDA noted the company’s FAQ page stated: “All of our products are FDA approved in FDA approved laboratories.” However, the FDA stated it “has not approved these products and FDA does not approve laboratories. In addition, FDA does not approve cosmetics or dietary supplements.”