Presentation on theme: "The Current State of Global Cosmetic Regulations"— Presentation transcript:
1The Current State of Global Cosmetic Regulations David C. Steinberg, FRAPSSteinberg & Associates, Inc.November 19, 2013
2Who Regulates Cosmetics in the United States? FDACosmeticDrugsFTCAdvertising claimsEPAVolatile Organic Compounds (VOC’s)State IssuesCaliforniaProposition 65Safe Cosmetic ActGreen ChemistryMinnesotaGlobal IssuesEUCanada
3Or Your customers Or their customers? Or the internet blogs? Many retail outlets are now banning ingredientsOr their customers?Consumers, lead by scare tactics, are demanding companies remove ingredientsOr the internet blogs?They have now replaced the press as the major outlet for junk science
4General FDA Regulations Cosmetics must be safeCosmetics must be properly labeledCosmetics must make only cosmetic claims
5Enforcement Of FDA Regulations Warning lettersProhibit product importationInspectionsSeizures (Recalls of Cosmetics and Monographed OTC drugs are voluntary)InjunctionsCriminal sanctions and fines[ FDA does not have independent litigating authority so seizures, injunctions and criminal proceedings are all processed by going through the Justice Department]
6FDA-CosmeticsCan take actions only if a product is adulterated or misbrandedIn 2011, they sent out 1 warning letter for cosmetic adulteration: Brazilian BlowoutOther cosmetic warning letters focused on adulteration or misbranding based upon the making of “drug claims”.
7FDA-Drugs and Cosmetics Very active in sending out Warning letters for unapproved or miss-labeled drugs. Cosmetic part works in conjunction with the Drug part. They have also requested voluntary recalls.Examples or unapproved drugs: Minoxidil with accelerators or products that claim hair growth and do not have a NDA or ANDA, Vagifresh Ball and Vagifresh Gel with benzocaine, Anti- bacteria lotions claiming anti-viral activity against H1N1Internet web sites are triggering many warning letters
8Customs Custom holds Send out for testing Place you on their “watch” list
10Unapproved colors Colors that are not allowed in cosmetics in the US Colors that are not allowed in that type of cosmetic-eye area, lips, etc.Colors not labeled correctly –using CI numbers as opposed to US namesCarmine and non-approved colors or chemicals listed in “May Contains” section; also listing here colors not permitted for this useColors not being batch certified if requiredColors not meeting self certification requirements.
11Microbial Contamination The FDA can take samples at Customs for microbial plate counts and identification of microbesCan declare products adulterated if contaminated.In 2011, they declared Bacillus cereus as opportunistic pathogen at levels of 1 cfu/g!
12Non Compliant LabelsNot having correct disclosure or location of net contentsIncorrect ingredient listings, especially incorrect listing of colors failing to use US namesCountry of originWarnings
13Incorrect Ingredient Listings Examples AquaWaterNatural glycerinGlycerinOrganic Sesame seed oilSesamum Indicum (Sesame) Seed OilVitamin E (Tocopherol)TocopherolOnly Colour Index NumbersBlue 1 (CI 42090) or CI (Blue 1)
14Fair Packaging & Labeling Act Requires full US address on the labelStreet and number may be omitted if the name is located in the phone directory of the city listedDo they still make phone books?They never heard of 800 numbers, or websitesWill they ever join the electronic age?
15Net Quantity or Contents Located on lower 30% of labelYou can have both Metric and English unitsCorrect Abbreviations mL, g, Oz., Fl.Oz.All Drugs (including OTC) must be labeled in MetricOnly 2 other countries-Liberia and Myanmar still use the English systemThe US is officially a Metric country!Law passed in 1867 established this and was never rescinded
16Unregistered Drugs Sunscreen labeled as cosmetics Simply saying SPF or contains sunscreens, makes you a drug unless covered by qualifying terms i.e. for hair protectionNot in FDA’s data base as having been properly registeredLabeler code, site license, product registration, US based FDA liaison.Lack of Drug Facts labelsLack of compliance with PLA way for consumers to report serious adverse reactions( must be in US)Drug claims for cosmeticsAnti-aging claims are frequently held by customs
18Cosmetics Regulated under VOC Regulations Hair Mousse, shines, gels, styling products, spraysNail polish removerFragrancesShaving creams and gelsTemporary aerosol hair colorsAntiperspirantsAstringentsDeodorant body sprays
19Latest Changes to FDA Regulations of Cosmetics Latest change is labeling carmineMust be on all labelsCannot be a “may contains” ingredientOnly in US-causing harmonization issuesNew Federal Regulations???Several Bills SubmittedMostly EWG promotedNot going anywhereTalks between industry & FDA have not been successful
20Why?House leader of the sub committee will only accept a bill that both industry and FDA will agree to (not the EWG!)FDA wants user feesIndustry may accept if only used for cosmeticsIndustry wants Federal PreemptionCalifornia, MinnesotaCalendar issues
21Calendar 2013-budget and debt ceiling 2014-silly season for House and 1/3 of Senate2015-silly season for President (it has already started!)2016-silly season for President and Congress2017-earliest I think Congress will consider any actionGeneral thought-more important issues for Congress than cosmeticsPS: Do you trust Congress?
23Proposition 65Proposition 65 is a requirement to warn if your product contains a chemical that the State has deemed to cause cancer or reproductive harmNew cosmetic chemical additionsMethanolBenzophenone (note only Benzophenone not Benzophenon with a number)Cocamide DEATitanium DioxideCurrent issuesAcrylamide for reproductive toxicity now has a Safe Harbor limit and is no longer an issueDEA content in TEA, MEA, amides
25You are Required To Register Your Product if it Contains As an Ingredient Titanium dioxideBlack 2Retinol or its estersBHACocamide DEAMethanolFormaldehyde solutionsBenzophenoneCoffee extractDiethanolamine
26Other IngredientsThere are 700+ chemicals but few other than those listed are used.No distinction between cosmetics or drugs that also make cosmetic claims.Name of company on the label is who must register.No minimum levels, only detection is needed.No money to enforce but is being cited in Prop 65 law suits.
27LawyersThe California lawyers who thrive on Prop. 65 lawsuits, are now filing false advertising suits under the California Consumers Legal Remedies Act.As with Prop 65 letters, the goal is to force settlements as quickly as they can by threatening major litigation
28California’s Green Chemistry Identify and prioritize chemical ingredients in consumer products that may be chemicals of concern, and to determine how best to limit or reduce the potential hazards posed by such chemicals.Exempted: Foods, prescription drugs, insecticidesWill identify "candidate" chemicals of concern and identify and prioritize products containing candidate chemicals.
29Must analyze alternatives to eliminate or reduce potential exposure to chemicals of concern in priority products.Prohibiting the sale and distribution of the product in California.
30Department of Toxic Substances Control (DTSC) 11/1/13 Post List of Chemicals 4/1/14 Priority List of 5 Chemicals 10/1/14 Proposed Candidates 12/1/14 Companies must notify the DTSC 12/1/15 Compliance required
31Candidate List – Used in Cosmetics Aluminum (includes powder)D-4: CyclotetrasiloxaneDEAD-6: CyclohexasiloxaneFormaldehydeMethyl AlcoholParabensToluene
32Summary Proposition 65 requires you to warn Safe Cosmetic Act requires you to registerGreen Chemistry can force you to remove your product
34HF 458Passed 5/13/13Prohibits formaldehyde, or formaldehyde releasers from children's products as of 8/1/14Children are defined as under 8 yearsCannot replace in cosmetics this with any chemical known or suspected to:
35Suspected (continued) Development toxicityCause cancer, genetic damage or reproductive harmDisrupt endocrine or hormone systemDamage nervous system, immune system, or cause systemic toxicity
36Leaving Limited problems for anhydrous products or emulsions And no known preservatives that work in surfactant based cleansers.What about traces of HCHO found in fatty alcohols which are the base for all surfactants and esters?
37Formaldehyde Releasing Preservatives Diazolidinyl UreaImidazolidinyl UreaDMDM HydantoinQuaternium-15Sodium HydroxymethylglycinateMethenamine*5-Bromo-5-Nitro-1,3-Dioxane*2-Bromo-2-Nitopropane-1,3-Diol**rarely used
38CompaniesYour retail customers are now requiring you to comply with their rules on product substantiation claims and ingredients.These include QVC and HSN; Wal-Mart, Boots, Whole Foods, Target and the trend is growing.Why?The constant attacks by you against your competitors who use “bad” ingredients, which, of course, you label as “Free”; has convinced stores to prohibit the use of many ingredients which are safe and confirmed to be safe by independent experts and the FDA.
39Formulating Request From One Company Can you make us a cosmetic line without any: Parabens, Alkyl or Alky Ether Sulfates, Petrochemicals, Carmine, tallow?Well I guess we can make vegetable soap and use vegetable oils as emollients; soap emulsifiers (and GMS) and thicken them with natural gums, but we can’t preserve any products and they will stink without any antioxidants and fragrances!
40The Final ResultPossibly Federal Legislation to require the FDA to pre-approve your products and all ingredients.This is the goal of many NGO’sThis will kill innovation and new productsYou can then claim innovation free!
42European Union United Kingdom Malta Sweden Denmark Cyprus Austria IrelandEstoniaFinlandFranceBulgariaCzech RepublicGermanyLuxembourgLatviaItalyNetherlandsLithuaniaBelgiumGreeceSlovakiaPolandSpainSloveniaHungaryPortugalRomaniaCroatia
43Official Languages Czech Estonian German Lithuanian Slovak Dutch FinnishItalianPolishSpanishDanish Greek Hungarian Maltese Slovene English French Latvian Portuguese Swedish
44Not Members but follow the Rules Norway, Iceland, LichtensteinSwitzerlandMost of Middle East, South Africa, Latin and South America China and Asean Countries
45European Regulations The Cosmetic Directive 76/768/EEC 8th Amendment 2013 changes this to a regulation40 Articles10 Annexes
46Short Version Must have an EU address Must have a Responsible Person Must have a Product Information PackageMust be RegisteredMust have correct labelingMust be compliant with REACH
47Estimated SymbolYou may put this symbol on the net contents line by voluntarily complying with the EU regulations for average fill.The US is a minimum fill country. By placing this on your product, you admit to violating our regulations!This mark only impacts intra European shipments and now has little value.Placing this mark on your label and not complying results in severe penalties in the EU.Minimum type size makes it look ugly!
51Registration of Cosmetics Prior to or within 10 days of first sale, all cosmetics must be registered in Canada by filing a Cosmetic Notification Form with Health Canada.Electronic version called CosMOS is now available
52On Line Cosmetic Notification Very user friendlyIntegrated with INCI DictionaryCan’t submit incorrect formsHot list and DSL are also integratedCan check statusPrevious submissions will be uploaded automatically
53Advertising and Labeling Claims June 2010 Health Canada issued new lists of acceptable cosmetic claims and claims that make you a drug.They are listed by Substrate, Product or ClaimClearly spell out what is a cosmetic claim and what is a drug claim
54Hot List Ingredients that are prohibited or restricted in cosmetics. Ingredients are added and can be removed at any time.Latest Changes are June New Proposals are open to current public comments
55Critical New Rules on Advertising Competition Bureau and Advertising Standards consider “free” claims to be false and misleading.Example: dynamite freeThey have issued conditions which must be met to make such a claim
56Conditions for “free” Claims The product must have contained this ingredient and was on the Canadian market with established registrations and dates.The Government must be notified that you removed this ingredient.Outside analysis must show that ZERO amount of this ingredient can be detectedYou are than allowed to make the claim…..free for only 1 year.At the end of 1 year, all products must be removed from the shelf.
57What You Can Say This product was never formulated with dynamite This product naturally contains no dynamiteWe do not have dynamite in this productHowever all of these claims must be true and provable.
58Environment Canada Domestic Substance List All ingredients must be on the DSL or In Commerce listIf not, they are subject to New Substance Notification RegulationsThreshold is 100 kg/year in Canada
59ConclusionsThe US is still the best place to introduce new ingredients and cosmetics!The US will soon be the only country to regulate sunscreens as drugs!European regulations make Japanese regulations look easy!Harmonization of regulations will never happen!Read my next (and last) column in Cosmetics & Toiletries magazine on how I think cosmetics should be regulated.