Beauty Store Business

OCT 2017

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52 October 2017 | accountability and intelligent regula- tion," Blinkoff explains. "We also have mandatory reporting of serious adverse events; if there's a problem with an ingredient, it'll surface quickly." And, Blinkoff points out, most ingredi- ents in common use have been reviewed by the CIR and the European Commission's Scientific Committee, while many ingre- dients have also been reviewed for other products, such as pharmaceuticals, food and color additives. "Ninety-nine percent of ingredients in common use for cosmet- ics are used in prescription and OTC drugs, and foods," she says. "How many times must you review the same data?" However, Faber disagrees, noting that the EWG doesn't support H.R. 575 because it doesn't provide the FDA with resources or require that the FDA review five ingredients each year. "The Sessions bill is designed to, in some ways, weaken cosmetics law, and it doesn't give the tools for the oversight that consumers would expect," Faber says. "It wasn't the product of a multiyear negotiation and has very little support in Congress. I'm not aware of any negative impact it would have on beauty stores, but there's very little chance it will become law." A MIDDLE GROUND The Personal Care Products Council does not explicitly support one bill or the other, but it has worked with govern- mental representatives for years to mod- ernize regulations on cosmetic safety. Instead, the organization has issued a list of principles that it feels are impor- tant priorities for the industry, updating the regulations in place since 1938. "Our industry has been at the table with a diverse group of stakeholders and bipartisan leaders in Congress, and we want to get it done; our commitment hasn't wavered in almost a decade," notes Lisa Powers, executive vice presi- dent for public affairs for The Personal Care Products Council. "We believe our products are the safest category that the FDA regulates, but we also believe the laws need to be updated. Ultimately, the process is fluid—not just for our industry, but all industries." Here, Hurson outlines some of the key principles the council supports: • National Program Uniformity: Pre- empt state and local laws that would duplicate new authorities in FDA regu- lation of cosmetics; preempt state and local laws for all cosmetic ingredients based on human health concerns if the FDA has reviewed the ingredient's safety or has been presented with a safety review of the ingredient by the CIR expert panel and, after a period for FDA review, has not rejected the CIR safety finding. • Mandatory Registration: Establish mandatory foreign and domestic manu- facturing establishment registration and ingredient reporting by manufacturers for all cosmetic products sold in the U.S. • Adverse Event Reporting: Require mandatory reporting by manufacturers to the FDA of serious and unexpected adverse health events experienced by a consumer from a cosmetic product marketed and used in the U.S. • Good Manufacturing Practices: Authorize the FDA to issue GMPs for cosmetic products. • Mandatory Recall: Provide the FDA authority to order a manda- tory recall of a product if a manu- facturer refuses to comply with an FDA request for a voluntary recall in which the FDA has a reasonable belief that the product is adulterated or otherwise is likely to cause seri- ous adverse health consequences. • FDA Cosmetic Ingredient Review: Create an FDA program authorized to review the safety of individual cos- metic ingredients and nonfunctional constituents found in cosmetics in a timely manner, and utilize widely accepted scientific principles, such as those reflected in the scientific reviews by the CIR expert panel and other sci- entifically based organizations. • Cosmetic Records Inspection: Allow the FDA to inspect a manufac- turer's records if the FDA has a rea- sonable belief that a cosmetic product presents a threat of serious adverse health consequences to humans. • Safety Substantiation: Require man- ufacturers to substantiate the safety of cosmetic products and ingredients, utilizing widely accepted scientific principles and established scientific ingredient reviews such as the CIR. Manufacturers may choose which FDA- accepted data to use. • Special Provisions for Small Busi- nesses: Allow flexibility for small businesses, as defined by the Small Business Administration, to comply with certain requirements, including additional time to submit ingredient statements to the FDA, simplified ingredient statements, additional FDA guidance on safety substantiation and an extended effective date for GMP compliance. Very small cosmetic man- ufacturers (those making less than $2 million in gross receipts annually in the U.S.) would be entirely exempt from any new requirements. • OTC and Cosmetic Regulation: When a product falls under the FDA's cosmetic and OTC drug authorities, and the requirements conflict, the OTC drug requirements will apply. • Alternatives to Animal Testing: Encourage FDA approval of alternatives to animal testing. • Importation: Bar importation of cosmetics produced outside the U.S. where the manufacturing facility or ingredient statement has not been registered with the FDA. "The bills we've discussed approach some of these concepts differently, and we like some of the approaches more than others, but we'll be happy to cover most of these principles," Hurson con- cludes. "For example, the Feinstein- Collins bill is not as strong as we'd like on national uniformity, and the Sessions bill is really strong on that, probably beyond the ability to get passed. We don't want the perfect to be the enemy of the good, and between those two is a middle ground. You can't pick one bill because they're going to change. We're not looking at the final pieces as they are now. We're not supporting any one piece of legislation, but we support everyone getting together and supporting common principles." As the debate con- tinues, retailers and brands can reach out directly to the offices of Senators Feinstein and Collins and Congressman Sessions to voice concerns and/or request information. ■ —Tracy Morin The Elite Eye Mask TO ORDER: 800.690.1654 DISTRIBUTOR PRICING FREE SHIPPING AVAILABLE Extends the life of lash extensions and strip lashes Protects eyes and lashes during sleep, massage and travel Washable One size fi ts all Introducing LashSavers TM Eye Mask

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