Sheppard Mullin Richter & Hampton LLP: If It's Neon, Should It Be On?

As summer is upon us, rebellious trend seekers can toss their black nail polish and opt for a shade of neon orange, green or pink. This season's en trend nail polish includes a color palette of neon hues that are rumored to be illegal in the U.S.. Contrary to recent alarmist headlines, it is not illegal to physically wear shockingly bright neon nail polish. However, it may be difficult to locate a truly neon polish at your local beauty store, since nail polish that includes neon coloration fails to comply with FDA regulation.

Although cosmetic products do not require FDA approval, color additives contained in cosmetics must be submitted to the FDA for approval prior to reaching the U.S. consumer marketplace. To pass FDA scrutiny, the tested color additive must meet composition and purity requirements, and there must be a reasonable certainty that the color additive will not be harmful when the product containing such additive is used for its intended purpose. A color additive that clears these safety hurdles is issued a certification lot number, which enables it to be used in FDA-approved products for their respective, specified uses.

Approved color additives are comprehensively indexed in the Code of Federal Regulations with an accompanying detailed description that specifically outlines the color additive's requisite chemical composition, temperature and proportion of ingredients. A true neon nail polish includes artificial color additives with distinct chemical compositions that do not pass the FDA test. One such additive is Yellow No. 5, which causes an allergic reaction in rare instances. Because of Yellow No. 5 and other similar additives commonly found in neon colorant, U.S. companies have chosen to refrain from investing the time and expense necessary to ensure FDA approval for the manufacture of neon nail polish. Thus, for those of us in the United States, the freshly painted neon colored nails we've seen on runways and streets alike are not likely neon at all, but rather a bright hue imposter.

While headlines claiming "if it's neon, it shouldn't be on" oversimplify the legal framework underlying the brilliant cosmetic trend of neon nail polish, there is a shade of truth to these colorful stories. The FDA has broad authority to enforce violations of its approval procedures that can dramatically impact a company's sales through seizure and/or recall of goods, whether such action occurs during manufacture, sale, or upon U.S. entry at Customs. Thus, the prudent cosmetics enterprise will be sure to avoid running afoul of the FDA by including color additives in its products that are cleared for use when targeting the ever fashionable U.S. consumer.

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