The Discreet Charm of the US Food, Drug and Cosmetic Act The Subtle Elegance of the EU Cosmetics Regulation Claire Bing, Director of Regulatory, Tarte Cosmetics Fred Lebreux, Chief Operating Officer, BIORIUS
Spirit of the Law Product safety Unfair commercial practices Consumer information
Culture, risk perception & system of values!! Attempts to harmonize TTIP 5
Two Occidental Societies, Two Cultures
1/ Consumer Information vs. Consumer Protection Warning--The safety of this product has not been determined. Do not worry, we protect you (even though you do want to be) You are responsible for (almost) nothing A problem? We are going to fix it We inform you, you decide Each one is responsible for its own life! A problem? Do not forget your rights
2/ The Precautionary Principle Article 191 of the Treaty on the Functioning of the EU Preventative decision-making Ex. Recital 36 / Articles 15,16 Proof of harm must be demonstrated before regulatory action is taken. Legal recourse in case of problem
The Two Cosmetics Legislation and their Status Transposed to the cosmetic sector by the EU Parliament & EU Council Comitology procedure / Regulatory Procedure with Scrutiny Treaty establishing the European Community Cosmetics Regulation EC No 1223/2009 Established by EU Member States Published in 2009 to achieve the internal market and a high level of consumer protection Complementary legal texts (e.g. EU No 655/2013) Amendment of annexes (as regulations)
The Two Cosmetics Legislation and their Status Constitution of the USA Federal Food, Drug, and Cosmetic Act Title 21, Chapter 9, Subchapter VI, sections 321-392 Fair Packaging and Labeling Act Title 15, Chapter 39, sections 1451-1460 C.F.R. «General» Title 21, Chapter 1, Subchapter G, Sections 700-740 (1938) Following a dramatic event to prevent the interstate trade of misbranded and adulterated products C.F.R. «Cosmetics Labeling» Title 16, Chapter 1, Subchapter E, Sections 500-503 (1967) An economic act to allow the consumer to make comparative value judgements in the marketplace regarding product purchases
A Notable Difference in the Geographical Scope but specific state provisions in some cases (e.g. Prop. 65) The EU Cosmetics Regulation applies even though the product is made and consumed in the same country! FD&C Act, sec. 201(b)]
What do we Mean by Cosmetic Product? [FD&C Act, sec. 201(i)] Soap OTC Drugs [21 CFR 701.20] [FD&C Act, sec. 201(g)(1)]] The product categories «drug» and «cosmetic» are not mutually exclusive in the USA!
Labeling Rules The concept of PDP! The elements to label are relatively similar but the US are more prescriptive about the format: Concept of Principal Display Panel (PDP) / Information Panel size matters! (and also proportions and angles ) [21 CFR 701.10, 701.13(e)] Minimal type size / letter height (specific to each element to label) [21 CFR 701.2(a)(b), 701.3(b), 701,11(c), 701,13(i), 740,2(b)]
Labeling Rules The concept of PDP! A few important differences: Name and place of business: it can be the manufacturer, the packer or distributor! [21 CFR 701.12] and [16 CFR 500.6] Specific warnings to display for Aerosols, Foaming Detergent Bath Products, Feminine Deodorant Sprays, tanning products, [21 CFR 740.1-17] Net content: in the US units (ex. fluid ounces) but metric system in addition is allowed. [21 CFR 701.13 (j)(2)&(n)] [16 CFR 500.6, 500.7, 500.8, 500.9 and 500.10 ]
Labeling Rules The concept of PDP! A few important differences: Name and place of business: it can be the manufacturer, the packer or distributor! [21 CFR 701.12] and [16 CFR 500.6] Specific warnings to display for Aerosols, Foaming Detergent Bath Products, Feminine Deodorant Sprays, tanning products, [21 CFR 740.1-17] Net content: in the US units (ex. fluid ounces) but metric system in addition is allowed. [21 CFR 701.13 (j)(2)&(n)] [16 CFR 500.6, 500.7, 500.8, 500.9 and 500.10 ]
Labeling Rules Do not forget to translate (or not)! English BUT if the label contains any foreign language representation: All statements required by regulation must also appear on the label in the foreign language. The required statements must appear on the label or other labeling as required in English.
Legal warnings Mainly on specific ingredients Mainly on cosmetic products Aerosols: Warning--Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120 F. Keep out of reach of children. Feminine Deodorant Sprays: Caution--Use only as directed. Excessive use of prolonged exposure may cause irritation to skin and urinary tract. Discontinue use if rash, redness or itching occurs. Consult your physician if irritation persists. Keep out of reach of children.
Ingredient Lists Not the same but close to! American «INCI» names Descending order of predominance but: Exception for OTC drugs: Active drug ingredients come first Exception for colorants: «May contain» OK, +/- not OK Exception for trade secrets: «and other ingredients» if the dossier is accepted by the FDA No obligation to list the fragrance allergens Parfum and Aroma to be listed as «Fragrance», «Flavor» or «Flavor and fragrance» No specific labeling requirements for nanomaterials [21 CFR 701.3] No obligation to list incidental ingredients Preservative of a raw material!!!
Example AQUA, PARAFFINUM LIQUIDUM, CETEARYL ALCOHOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, GLYCERIN, SIMMONDSIA CHINENSIS SEED OIL, STEARIC ACID, POLYSORBATE 40, POLYSORBATE 60, DIMETHICONE, TRIETHANOLAMINE, DMDM HYDANTOIN, DISODIUM EDTA, PARFUM, HEXYL CINNAMAL, BUTYLENE GLYCOL, CITRONELLOL, HYDROXYCITRONELLAL, GERANIOL, BUTYLPHENYL METHYLPROPIONAL, CI 77491 WATER/AQUA, MINERAL OIL, CETEARYL ALCOHOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, GLYCERIN, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, STEARIC ACID, POLYSORBATE 40, POLYSORBATE 60, DIMETHICONE, TRIETHANOLAMINE, DMDM HYDANTOIN, DISODIUM EDTA, FRAGRANCE, BUTYLENE GLYCOL, IRON OXIDES (CI 77491)
Colorants (are a big deal in the US) [FD&C Act, Sec. 721; 21 U.S.C. 379e; 21 CFR 70 & 80] Compliance with the positive list Compliance with identity and specifications requirements Compliance with the restrictions of the product category Batch certified by FDA for some colorants
The Exception: Coal-tar hair dyes I think that this is ok. I think you re nuts. No positive list No required safety assessment (while known to be potent allergens, eye damaging ingredients and/or causing bladder cancer) Just one warning to label: Caution - This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness.
Safety assessment (is a big deal in the EU) Hazard assessment and dose-response of all substances Exposure assessment Risk assessment Risk management Companies and individuals who market cosmetics have a legal responsibility to ensure the safety of their products.
Prohibited & Restricted Ingredients 6 bans, 3 restrictions = 9 entries 1379 Annex II bans, 287 Annex III restrictions, etc. II, 203 Warfarin II, 268 Picric acid II, 280 Thalidomide II, 293 Radioactive substances II, 323 Vaccines, toxins and serums II, 416 Cells, tissues or products of human origin II, 462 Carbon monoxide II, 762 Asbestos [21 CFR 700.11-27 & 250.250]
Good Manufacturing Practices Article 8: Complying with GMP is a legal requirement. Following GMP is a recommendation! (but: ) The law prohibits the placing on the market of adulterated or misbranded products. The risk of adulterating or misbranding cosmetics can be reduced by following GMP. GMP is required for US manufacturers FDA published a «Guidance for Industry: Cosmetic Good Manufacturing Practices» (equivalent to ISO Norm 22716). FDA has the authority to inspect facilities as well as all pertinent equipment, finished and unfinished materials, containers and labeling therein. [21 CFR 704(a)]
CPNP Notification vs. VCRP I do not ask for premarket approval Me neither, post-marketing surveillance is great! Notification is mandatory in the EU while registration of cosmetics is a voluntary program in the US. Participating in VCRP is always good. It can be helpful if something goes wrong! Post-marketing surveillance is a core responsibility of the Competent Authorities in the EU. In the US too but consumers, NGO s and Federal Trade Commision play a more important role!
Class Actions Tell me I am dreaming! August 2016: Starbucks false advertising case dismissed: Yes, cold drinks contain ice A group of US consumers (namely from 2 people) have the possibility to start a collective legal initiative against a company. US Consumers are more litigious than their EU counterparts. It can be related to safety, labeling, claims or marketing-way.
Talking about claims Like in the EU, the US legislation prohibits to make claims going beyond the scope of cosmetic definition but the US did not enforce specific legal instruments such as EU No 655/2013 and their legislation can be regarded as less stringent although requiring equivalent substantiation. «Claims must be truthful and not misleading».
Talking about claims FDA does not have the authority to approve claims before cosmetics go on the market but it monitors the market with Federal Trade Commission and may send warning letters to companies. FDA and FTC are carefully inspecting cosmetic products for nonsubstantiated misleading claims.
Responsibility The EU established the concept of a unique responsible person who takes the blame for everything that may happen related to a given cosmetic product. FDA may sue any stakeholder who has some responsibility in a problem (manufacturer, brand, packager, distributor, importer, ) Brand is generally the primary responsible person
Change is expected in the US! S.1014 - Personal Care Products Safety Act (so called Feinstein Bill ) or H.R.4075 Cosmetic Modernization Amendments of 2015 (so called Sessions Bill ) and H.R.2858 - Humane Cosmetics Act
S.1014 Personal Care Products Safety Act Sen. Feinstein, Dianne [D-California] + 6 co-sponsors Big changes to foresee: Concept of Responsible Person Mandatory safety assessment Mandatory registration Management of UE Mandatory GMP compliance Harmonization in all states FDA with enhanced powers Promotion of alternatives to animal testing
S.1014 Registration of cosmetic facilities The RP (brand owner or contract manufacturer in some cases) shall register its cosmetic facilities and reconfirm it every year. every year Simplified procedure Electronic Unique identifier SEC. 744L. Exempted if turnover < 500,000$
S.1014 Registration of cosmetic products The RP shall register its cosmetic products and reconfirm it every year. every year Simplified procedure Electronic Safety declaration for the product and its ingredients Unique number ~ CPNP number
S.1014 Safety dossier & cosmetovigilance The RP shall prepare a dossier supporting the safe use of the product, To be kept current and, To be maintained until 5 years after the finished product is no longer marketed. The safety dossier may be consulted by the FDA if needed. Undesirable effects will be managed by the RP and the FDA will be informed about SUE within 15 days. Undesirable Effects reports will be kept at least 6 years.
H.R.4075 Cosmetic Modernization Amendments of 2015 Rep. Sessions, Pete [R-Texas] + 2 co-sponsors Big changes to foresee: Mandatory registration Management of SUE Mandatory GMP compliance Harmonization in all states (do not say a lot about safety)
H.R.2858 Humane Cosmetics Act Rep. McSally, Martha [R-Arizona] Big change to foresee: Ban of the animal testing on finished cosmetic products and its ingredients + 155 co-sponsors
Conclusions Do not underestimate the US legislation: less prescriptive does not mean less demanding! If you do not behave well (and even though you do), consumers may cause you more problems than the Authorities. Responsibility in US is determined by who is at fault, not for guaranteed safety. This is how the US perceives the concept of responsibility.
Conclusions We don t have the same history or the same values or the same culture but we have the same issues or the same perceptions and recognize the merits of harmonization! The future US cosmetics legislation is likely to use the same logic as the EU text in particular in relation to formulation.
The Discreet Charm of the US Food, Drug and Cosmetic Act The Subtle Elegance of the EU Cosmetics Regulation Claire Bing, Director of Regulatory, Tarte Cosmetics, claireb@tarte.com Fred Lebreux, Chief Operating Officer, BIORIUS, frederic.lebreux@biorius.com