JAN-FEB 2016

MedEsthetics—business education for medical practitioners—provides the latest noninvasive cosmetic procedures, treatment trends, product and equipment reviews, legal issues and medical aesthetics industry news.

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16 JANUARY/FEBRUARY 2016 | Med Esthetics LEGAL ISSUES framework for a modernized law, but those discussions broke down in 2014. California Senator Dianne Feinstein and Maine Senator Susan Collins introduced the Personal Care Products Safety Act in April 2015. Their bill has the support of the Personal Care Products Council and the International Fragrance Association; several large manufacturers, including Revlon, Estée Lauder, L'Oréal and Johnson & Johnson; and con- sumer groups, including the Environmental Working Group, the National Alliance for Hispanic Health and the National Psoriasis Foundation. The Independent Cosmetic Manufactur- ers and Distributors (ICMAD) and the Handmade Cosmetic Alliance as well as others oppose it. An alternative bill—the Safe Cosmetics Modernization Act—based on the failed Cosmetic Safety Amendments Act of 2012 was recently introduced in the U.S. House of Representatives by Texas representative Pete Sessions. The alternative bill is championed by ICMAD. CURRENT REGULATIONS Under the existing law most ingredients in cosmetics, unlike drugs, are not approved by the FDA before they are mar- keted—although some particularly toxic cosmetics ingredi- ents are banned. The only ingredients that must be reviewed by the FDA before they are incorporated into cosmetics— called a premarket review—are color additives. The FDA's primary opportunity to review the safety of a cosmetic is after a product is marketed, and then the FDCA allows the FDA to sue to prohibit adulterated and misbranded cosmetics from being marketed in interstate commerce. Cosmetics are adulterated if they have ingredients that could cause injury, are contaminated, contain a prohibited color additive, or are manufactured or stored in an unsanitary manner. Cosmet- ics are misbranded if they have labels that are incorrect, misleading, incomplete, lack mandated information or are packaged misleadingly. Cosmetics manufacturers are not required to perform any specifi c tests for product safety, although they are responsible for the safety of cosmetics and ingredients. If it becomes law, the Personal Care Products Safety Act will require that at least fi ve ingredients and byproducts be tested each year by the FDA to evaluate their safe use. The FDA must fi nd one of three things: (i) the substance is safe under specifi ed conditions; (ii) it is safe under all conditions; or (iii) it is not safe for use in cosmetics under any conditions. The FDA will then issue orders mandating conditions of use for ingredients, regulating any byproducts and specifying any required consumer warnings. All Internet retailers must include the warnings and product-label information on their websites. Any product that is not safe under any condi- tions, or that is not safe under the conditions suggested in the label, will be defi ned as adulterated and may not be used. The FDA must consider whether there is "adequate evidence to support a reasonable certainty among competent scientists that the ingredi- ent is not harmful," taking into account the probable exposures and cumulative exposures to the substance from all sources. All available test results must be considered. These chemicals would be evaluated in the fi rst year: • Diazolidinyl urea, a preservative • Lead acetate, a color additive in hair dyes • Methylene glycol/formaldehyde, used in hair treatments • Propyl paraben, a preservative that mimics estrogen • Quaternium-15, another preservative Manufacturers or packers with more than $100,000 in gross annual cosmetics sales must make a written deter- mination that fi nished cosmetics products are safe if used in accordance with their labels before the product may be distributed. The safety determination must be based on a recognized expert organization's conclusions that the product is safe, or testing, or some other "appropriate safety substan- tiation of the fi nished product." The bill also requires the industry to submit ingredient state- ments every year, which must include a full list of ingredients, including ranges of substances present, all fragrances and fl avors, and the identity of the fragrance and fl avor suppliers. The suppliers must identify the ingredients in their products at the FDA's request. The cosmetics ingredient statements must include an attestation that the safety of the product and its ingredients have been substantiated. Small businesses may submit a streamlined statement, and they have a longer grace period to submit the statements after marketing a product. The FDA must keep a list of all cosmetics distributed in the U.S. together with their ingredients, and provide it to the states on request. States must maintain the information as a trade secret. The FDA may suspend a facility's registration if products manufactured, packed or stored there have a reasonable probability of causing serious adverse health consequences or death. The suspension bars anyone from distributing cos- metics from that facility. A cosmetics ingredient statement may be suspended for the same reasons, and a suspension bars anyone from distributing that product. © GETTY IMAGES

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