The Current State of Global Cosmetic Regulations David C. Steinberg, FRAPS Steinberg & Associates, Inc. November 19, 2013

Who Regulates Cosmetics in the United States? 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

Or Your customers Or their customers? Or the internet blogs? 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

General FDA Regulations Cosmetics must be safe Cosmetics must be properly labeled Cosmetics must make only cosmetic claims

Enforcement Of FDA Regulations 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]

FDA-Cosmetics 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”.

FDA-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 H1N1 Internet web sites are triggering many warning letters

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

Major Reasons Unapproved colors Microbial contamination Incorrect Labels Unregistered drugs VOC violations

Unapproved 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 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.

Microbial Contamination 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!

Non Compliant Labels 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

Incorrect Ingredient Listings Examples 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 42090 (Blue 1)

Fair Packaging & Labeling Act 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, email or websites Will they ever join the electronic age?

Net Quantity or Contents 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

Unregistered Drugs 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 109-462 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

VOC Violations EPA requirements California

Cosmetics Regulated under VOC Regulations Hair Mousse, shines, gels, styling products, sprays Nail polish remover Fragrances Shaving creams and gels Temporary aerosol hair colors Antiperspirants Astringents Deodorant body sprays

Latest Changes to FDA Regulations of Cosmetics 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

Why? 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

Calendar 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?

State of California

Proposition 65 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

The California Safe Cosmetic Act of 2005

You are Required To Register Your Product if it Contains As an Ingredient Titanium dioxide Black 2 Retinol or its esters BHA Cocamide DEA Methanol Formaldehyde solutions Benzophenone Coffee extract Diethanolamine

Other Ingredients 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.

Lawyers 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

California’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, insecticides Will identify "candidate" chemicals of concern and identify and prioritize products containing candidate chemicals.

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.

Department 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

Candidate List – Used in Cosmetics Aluminum (includes powder) D-4: Cyclotetrasiloxane DEA D-6: Cyclohexasiloxane Formaldehyde Methyl Alcohol Parabens Toluene

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

Minnesota

HF 458 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:

Suspected (continued) Development toxicity Cause cancer, genetic damage or reproductive harm Disrupt endocrine or hormone system Damage nervous system, immune system, or cause systemic toxicity

Leaving 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?

Formaldehyde Releasing Preservatives 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

Companies 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.

Formulating 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!

The Final Result 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!

European Union

European Union United Kingdom Malta Sweden Denmark Cyprus Austria Ireland Estonia Finland France Bulgaria Czech Republic Germany Luxembourg Latvia Italy Netherlands Lithuania Belgium Greece Slovakia Poland Spain Slovenia Hungary Portugal Romania Croatia

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

Not Members but follow the Rules Norway, Iceland, Lichtenstein Switzerland Most of Middle East, South Africa, Latin and South America China and Asean Countries

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

Short Version 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

Estimated Symbol 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!

Sometimes called the “e” mark ℮

Consumers Right to Know Type of Product Qualitative Formulation Adverse health affects Quantitative amounts of “Dangerous Substances”

Canada

Registration 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

On Line Cosmetic Notification 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

Advertising 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 Claim Clearly spell out what is a cosmetic claim and what is a drug claim

Hot List Ingredients that are prohibited or restricted in cosmetics. Ingredients are added and can be removed at any time. Latest Changes are June 2010. New Proposals are open to current public comments

Critical New Rules on Advertising 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

Conditions 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 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.

What You Can Say 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.

Environment Canada 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

Conclusions 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.

Questions? davidpreserve@comcast.net

Thank You!