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David C. Steinberg, FRAPS Steinberg & Associates, Inc. November 19, 2013.

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Presentation on theme: "David C. Steinberg, FRAPS Steinberg & Associates, Inc. November 19, 2013."— Presentation transcript:

1 David C. Steinberg, FRAPS Steinberg & Associates, Inc. November 19, 2013

2  FDA ◦ Cosmetic ◦ Drugs  FTC ◦ Advertising claims  EPA ◦ Volatile Organic Compounds (VOC’s)  State Issues ◦ California  Proposition 65  Safe Cosmetic Act  Green Chemistry ◦ Minnesota  Global Issues ◦ EU ◦ Canada

3  Your customers ◦ Many retail outlets are now banning ingredients  Or their customers? ◦ Consumers, lead by scare tactics, are demanding companies remove ingredients  Or the internet blogs? ◦ They have now replaced the press as the major outlet for junk science

4  Cosmetics must be safe  Cosmetics must be properly labeled  Cosmetics must make only cosmetic claims

5  Warning letters  Prohibit product importation  Inspections  Seizures (Recalls of Cosmetics and Monographed OTC drugs are voluntary)  Injunctions  Criminal 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]

6 Can take actions only if a product is adulterated or misbranded In 2011, they sent out 1 warning letter for cosmetic adulteration: Brazilian Blowout Other cosmetic warning letters focused on adulteration or misbranding based upon the making of “drug claims”.

7 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 H1N1 Internet web sites are triggering many warning letters

8  Custom holds  Send out for testing  Place you on their “watch” list

9  Unapproved colors  Microbial contamination  Incorrect Labels  Unregistered drugs  VOC violations

10  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 names  Carmine and non-approved colors or chemicals listed in “May Contains” section; also listing here colors not permitted for this use  Colors not being batch certified if required  Colors not meeting self certification requirements.

11  The FDA can take samples at Customs for microbial plate counts and identification of microbes  Can declare products adulterated if contaminated. ◦ In 2011, they declared Bacillus cereus as opportunistic pathogen at levels of 1 cfu/g!

12  Not having correct disclosure or location of net contents  Incorrect ingredient listings, especially incorrect listing of colors failing to use US names  Country of origin  Warnings

13  Aqua ◦ Water  Natural glycerin ◦ Glycerin  Organic Sesame seed oil ◦ Sesamum Indicum (Sesame) Seed Oil  Vitamin E (Tocopherol) ◦ Tocopherol  Only Colour Index Numbers ◦ Blue 1 (CI 42090) or CI (Blue 1)

14  Requires full US address on the label ◦ Street and number may be omitted if the name is located in the phone directory of the city listed ◦ Do they still make phone books? ◦ They never heard of 800 numbers, or websites ◦ Will they ever join the electronic age?

15  Located on lower 30% of label  You can have both Metric and English units  Correct Abbreviations mL, g, Oz., Fl.Oz.  All Drugs (including OTC) must be labeled in Metric  Only 2 other countries-Liberia and Myanmar still use the English system  The US is officially a Metric country! ◦ Law passed in 1867 established this and was never rescinded

16 Sunscreen labeled as cosmetics – Simply saying SPF or contains sunscreens, makes you a drug unless covered by qualifying terms i.e. for hair protection Not in FDA’s data base as having been properly registered – Labeler code, site license, product registration, US based FDA liaison. Lack of Drug Facts labels Lack of compliance with PL – A way for consumers to report serious adverse reactions( must be in US) Drug claims for cosmetics – Anti-aging claims are frequently held by customs

17  EPA requirements  California

18  Hair Mousse, shines, gels, styling products, sprays  Nail polish remover  Fragrances  Shaving creams and gels  Temporary aerosol hair colors  Antiperspirants  Astringents  Deodorant body sprays

19  Latest change is labeling carmine ◦ Must be on all labels ◦ Cannot be a “may contains” ingredient  Only in US-causing harmonization issues  New Federal Regulations??? ◦ Several Bills Submitted ◦ Mostly EWG promoted ◦ Not going anywhere  Talks between industry & FDA have not been successful

20  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 fees  Industry may accept if only used for cosmetics ◦ Industry wants Federal Preemption  California, Minnesota  Calendar issues

21  2013-budget and debt ceiling  2014-silly season for House and 1/3 of Senate  2015-silly season for President (it has already started!)  2016-silly season for President and Congress  2017-earliest I think Congress will consider any action  General thought-more important issues for Congress than cosmetics ◦ PS: Do you trust Congress?

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23  Proposition 65 is a requirement to warn if your product contains a chemical that the State has deemed to cause cancer or reproductive harm  New cosmetic chemical additions ◦ Methanol ◦ Benzophenone (note only Benzophenone not Benzophenon with a number) ◦ Cocamide DEA ◦ Titanium Dioxide  Current issues ◦ Acrylamide for reproductive toxicity now has a Safe Harbor limit and is no longer an issue ◦ DEA content in TEA, MEA, amides

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25  Titanium dioxide  Black 2  Retinol or its esters  BHA  Cocamide DEA  Methanol  Formaldehyde solutions  Benzophenone  Coffee extract  Diethanolamine

26  There 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.

27  The 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

28  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, insecticides  Will identify "candidate" chemicals of concern and identify and prioritize products containing candidate chemicals.

29 Must 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.

30 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

31  Aluminum (includes powder)  D-4: Cyclotetrasiloxane  DEA  D-6: Cyclohexasiloxane  Formaldehyde  Methyl Alcohol  Parabens  Toluene

32  Proposition 65 requires you to warn  Safe Cosmetic Act requires you to register  Green Chemistry can force you to remove your product

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34  Passed 5/13/13  Prohibits formaldehyde, or formaldehyde releasers from children's products as of 8/1/14  Children are defined as under 8 years  Cannot replace in cosmetics this with any chemical known or suspected to:

35  Development toxicity  Cause cancer, genetic damage or reproductive harm  Disrupt endocrine or hormone system  Damage nervous system, immune system, or cause systemic toxicity

36 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?

37  Diazolidinyl Urea  Imidazolidinyl Urea  DMDM Hydantoin  Quaternium-15  Sodium Hydroxymethylglycinate  Methenamine*  5-Bromo-5-Nitro-1,3-Dioxane*  2-Bromo-2-Nitopropane-1,3-Diol* *rarely used

38 Your 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.

39  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!

40 Possibly Federal Legislation to require the FDA to pre-approve your products and all ingredients. This is the goal of many NGO’s This will kill innovation and new products You can then claim innovation free!

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42 United KingdomMaltaSweden DenmarkCyprusAustria IrelandEstoniaFinland FranceBulgariaCzech Republic GermanyLuxembourgLatvia ItalyNetherlandsLithuania BelgiumGreeceSlovakia PolandSpainSlovenia HungaryPortugalRomania Croatia

43 Czech Estonian German Lithuanian Slovak Dutch Finnish Italian Polish Spanish Danish Greek Hungarian Maltese Slovene English French Latvian Portuguese Swedish

44  Norway, Iceland, Lichtenstein  Switzerland  Most of Middle East, South Africa, Latin and South America China and Asean Countries

45  The Cosmetic Directive 76/768/EEC  8th Amendment 2013 changes this to a regulation  40 Articles  10 Annexes

46  Must have an EU address  Must have a Responsible Person  Must have a Product Information Package  Must be Registered  Must have correct labeling  Must be compliant with REACH

47  You 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!

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49  Type of Product  Qualitative Formulation  Adverse health affects  Quantitative amounts of “Dangerous Substances”

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51  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

52 Very user friendly Integrated with INCI Dictionary Can’t submit incorrect forms Hot list and DSL are also integrated Can check status Previous submissions will be uploaded automatically

53  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 Claim  Clearly spell out what is a cosmetic claim and what is a drug claim

54  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

55  Competition Bureau and Advertising Standards consider “free” claims to be false and misleading.  Example: dynamite free  They have issued conditions which must be met to make such a claim

56  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 detected  You 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.

57 This product was never formulated with dynamite This product naturally contains no dynamite We do not have dynamite in this product However all of these claims must be true and provable.

58  Domestic Substance List ◦ All ingredients must be on the DSL or In Commerce list ◦ If not, they are subject to New Substance Notification Regulations ◦ Threshold is 100 kg/year in Canada

59  The 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.

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