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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a g a i nst a d u l terate d or m i s b ran d e d cosmet i cs b y b r i n gi n g a l awsuit to ban their sale. The FDA can also have the p roducts se i ze d an d can b r i n g cr i m i na l c h ar g es a g a i nst t h e v i o l ators. C ontinuin g the voluntary initiatives under the curren t l aw, the Personal C are Products Safet y Act would re q uire the FDA to g ive manufacturers the opportunity to volun - taril y recall adulterated or misbranded cosmetics. The FD A ma y then order the com p an y to recall a cosmetic and notif y distributors and retailers. A p ress release must be issued that includes information about similar products not sub j ec t to th e r e c a ll . F EDERAL PREEMPTI ON With man y exce p tions, f ederal law p reem p ts state laws govern i ng cosmet i cs pac k ag i ng an d l a b e li ng. Wh ere t h ere are gaps in the FDCA, states may issue regulations—and man y states h ave ta k en t h e opportun i ty to i ssue t h e i r own re g u l a - tions—which are bindin g in addition to FDA re g ulations. For exam p le, the C hildren's Safe Products Act in Wash - i n g ton state requires manu f acturers o f cosmetics tar g eted to children under 1 2 to re p ort if children's cosmetics contain any of 66 hi g h-priority chemicals. C alifornia has a law re - quirin g cosmetics manufacturers to submit lists of products that contain carcino g ens or cause reproductive toxicity. These state laws can create burdens on com p anies that sell p roducts a cro ss s t a t e lin es or n a tionwid e . The Personal C are Products Safet y Act has a com p le x preemption provision. It permits all the state sa f ety re g ulations th a t a r e in effe ct a t th e tim e th e l a w i s e n a ct e d to continu e in effe ct. But unl ess a s t a t e l a w i s on th e book s wh e n th e fe d e r a l bill becomes law, states cannot require registration, GMPs, recalls or adverse event reporting. O nly those current state sa f et y laws that are more restrictive than an FDA fi nal sa f et y o rder ma y be en f orced once the FDA issues its fi nal order. I f the FDA has p ro p osed a substance f or sa f et y review, then states ma y not i m p ose new re q u i rements on t h at su b stance. In a reference to p reem p tion, I C MAD's anal y sis concludes that the Personal C are Products Safet y Act doesn't have " appropriate and si g nifi cant national uniformity." Finall y , the bill p rovides f or f ees to f und sa f et y activities f rom re g istrants whose g ross cosmetics sales for the prio r three years is more than $300,000. The FDA's tar g et is to collect $20.6 million from industry. The fees ran g e from $250 to $1.1 million in the fi rst year. Th is copyrig h te d artic l e is inten d e d to h e l p ma k e you aware o f some o f the issues that y ou ma y f ace, but it is not exhaustive an d d oes not constitute l ega l a d vice . J ean Wars h a w i s a l aw y er i n p r i vate p ract i ce i n N ew Y or k C it y . She p rovides advice on business and environmental law. She can be reached at 2 1 2 . 722 . 22 40 . MAN U FA C T U RER RE G I S TRATI ON U n d er t h e current l aw, cosmet i cs compan i es—un lik e d rug companies—are not required to register with the FDA, bu t m a y do so under a voluntar y initiative. Manu f acturers, p ack - ers or distributors ma y also fi le a voluntar y disclosure o f the pro d uct i ngre di ents . The Personal C are Products Safet y Act would re q uire a ll cosmetics manufacturers and processors to re g ister thei r facilities annually. Packa g ers and stora g e facilities would have t o re g ister once every three years. C ompanies with g ross sales avera g in g at least $500,000 would have to pay a re g istration fee. The FDA will compile and keep a re g istr y of co s m e tic s f a ciliti es. GOO D MAN U FA C T U RIN G PRA C TI C E S A s o f now, the FDA has issued g uidance f or sa f e cosmetics m anu f acturing practices but has not required manu f acturers t o adhere to them. These " good manufacturing practices" (GMPs) include general hygiene precautions such as making sure workers don't eat in the manu f acturing areas, equip - m ent is sanitized a pp ro p riatel y and condensate f rom p i p es d oesn ' t contam i nate t h e p ro d ucts. Under the Personal C are Products Safet y Act, the FDA mus t develop G MPs and propose re g ulations with the ob j ective o f h armon i z i n g w i t h i nternat i ona l stan d ar d s. Th e ru l e must b e fi nalized within three y ears of the law's enactment. It would a pply to lar g e businesses six months after the rule is fi nal, and t o small businesses two y ears after the rule is fi na l . REP O RTIN G IN JU RIE S The current law does not re q uire cosmetics com p anies to report to the FD A when consumers are in j ured or experience p roblems with cosmetics. The bill would re q uire manu f actur - ers and packers with more than $ 100,000 in g ross annual sales to include contact in f ormation on the packa g in g so t hat consumers can tell them when the y have suffered a dverse effects from the p roduct. The manufacturers and p ackers must, in turn, re p ort to the FDA if there is an y serious adverse event associated with a p roduct and submi t a n annual summar y of the re p orts that y ear. Events that lead t o death, hospitalization, persistent or si g nifi cant disability, disfi g urement or birth defects are all defi ned as si g nifi can t a nd adverse, as are events that require medical or sur g ical response to prevent those effects. The bill says that fi lin g a re p ort is not an admission that the cosmetic caused the a dverse e ff ect, but the re p orts will doubtlessl y be a resource f or products-liability lawyers seeking to fi le lawsuit s . PR O D UC T RE C ALL S The FDCA does not g ive the FDA authority to recall dan g er - ous cosmetics products. The a g ency can en f orce the laws LEGAL ISSUES 18 JANUARY/FEBRUARY 2016 | Med Esthetics

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