David C. Steinberg, FRAPS
Steinberg & Associates, Inc.
November 19, 2013
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FDA
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FTC
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EPA
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State Issues
◦ Cosmetic
◦ Drugs
◦ Advertising claims
◦ Volatile Organic Compounds (VOC’s)
◦ California
 Proposition 65
 Safe Cosmetic Act
 Green Chemistry
◦ Minnesota
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Global Issues
◦ EU
◦ Canada
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Your customers
◦ Many retail outlets are now banning ingredients
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Or their customers?
◦ Consumers, lead by scare tactics, are demanding
companies remove ingredients
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Or the internet blogs?
◦ They have now replaced the press as the major
outlet for junk science
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Cosmetics must be safe
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Cosmetics must be properly labeled
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Cosmetics must make only cosmetic claims
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]
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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”.
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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, Antibacteria lotions claiming anti-viral activity
against H1N1
Internet web sites are triggering many warning
letters
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Custom holds
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Send out for testing
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Place you on their “watch” list
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Unapproved colors
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Microbial contamination
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Incorrect Labels
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Unregistered drugs
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VOC violations
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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.
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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!
 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
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Aqua
◦ Water
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Natural glycerin
◦ Glycerin
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Organic Sesame seed oil
◦ Sesamum Indicum (Sesame) Seed Oil
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Vitamin E (Tocopherol)
◦ Tocopherol
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Only Colour Index Numbers
◦ Blue 1 (CI 42090) or CI 42090 (Blue 1)
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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?
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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
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Sunscreen labeled as cosmetics
– Simply saying SPF or contains sunscreens, makes you a
drug unless covered by qualifying terms i.e. for hair
protection
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Not in FDA’s data base as having been properly
registered
– Labeler code, site license, product registration, US based
FDA liaison.
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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)
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Drug claims for cosmetics
– Anti-aging claims are frequently held by customs
 EPA
requirements
 California
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Hair Mousse, shines, gels, styling products,
sprays
Nail polish remover
Fragrances
Shaving creams and gels
Temporary aerosol hair colors
Antiperspirants
Astringents
Deodorant body sprays
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Latest change is labeling carmine
◦ Must be on all labels
◦ Cannot be a “may contains” ingredient
 Only in US-causing harmonization issues
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New Federal Regulations???
◦ Several Bills Submitted
◦ Mostly EWG promoted
◦ Not going anywhere
 Talks between industry & FDA have not been
successful
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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
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Calendar issues
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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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Proposition 65 is a requirement to warn if your
product contains a chemical that the State has
deemed to cause cancer or reproductive harm
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New cosmetic chemical additions
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Current issues
◦ Methanol
◦ Benzophenone (note only Benzophenone not Benzophenon
with a number)
◦ Cocamide DEA
◦ Titanium Dioxide
◦ 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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Titanium dioxide
Black 2
Retinol or its esters
BHA
Cocamide DEA
Methanol
Formaldehyde
solutions
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Benzophenone
Coffee extract
Diethanolamine
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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.
 The California lawyers who thrive on
Prop. 65 lawsuits, are now filing false
advertising suits under the California
Consumers Legal Remedies Act.
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As with Prop 65 letters, the goal is to force
settlements as quickly as they can by
threatening major litigation
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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
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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.
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
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Aluminum (includes powder)
D-4: Cyclotetrasiloxane
DEA
D-6: Cyclohexasiloxane
Formaldehyde
Methyl Alcohol
Parabens
Toluene
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Proposition 65 requires you to warn
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Safe Cosmetic Act requires you to register
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Green Chemistry can force you to remove
your product
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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:
Development toxicity
 Cause cancer, genetic damage or
reproductive harm
 Disrupt endocrine or hormone
system
 Damage nervous system, immune
system, or cause systemic toxicity
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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?
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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
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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.
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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!
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Possibly Federal Legislation to require
the FDA to pre-approve your products
and all ingredients.
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This is the goal of many NGO’s
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This will kill innovation and new
products
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You can then claim innovation free!
United Kingdom
Denmark
Ireland
France
Malta
Sweden
Cyprus
Austria
Estonia
Bulgaria
Finland
Czech Republic
Germany
Luxembourg
Latvia
Italy
Netherlands
Lithuania
Belgium
Greece
Slovakia
Poland
Spain
Slovenia
Hungary
Portugal
Romania
Croatia
Czech
Estonian
German
Lithuanian
Slovak
Dutch
Finnish
Italian
Polish
Spanish
Danish
Greek
Hungarian
Maltese
Slovene
English
French
Latvian
Portuguese
Swedish
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Norway, Iceland, Lichtenstein
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Switzerland
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Most of Middle East, South Africa, Latin and
South America China and Asean Countries
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The Cosmetic Directive 76/768/EEC
8th Amendment 2013 changes this to a
regulation
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40 Articles
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10 Annexes
 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
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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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Type of Product
Qualitative Formulation
Adverse health affects
Quantitative amounts of “Dangerous
Substances”
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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
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
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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
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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
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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
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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.
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This product was never formulated with
dynamite
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This product naturally contains no dynamite
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We do not have dynamite in this product
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However all of these claims must be true and
provable.
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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
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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.
davidpreserve@comcast.net