Cosmetics – FDA Regulatory Programs and Perspectives

1. Cosmetics – FDA Regulatory Programs and Perspectives Association of Food And Drug Officials 117th Annual Educational Conference June 11, 2013 Patricia A. Hansen, Ph.D. Deputy Director Office of Cosmetics and Colors U.S. Food and Drug Administration

2. Outline • FDA’s statutory authorities, regulations • FDA regulatory tools and programs • Examples of recent issues and activities • Interest in augmenting FDA’s statutory authorities

3. Cosmetics – Scope • Used by most consumers every day • Examples: • Moisturizers, other skin preparations • Hair care, hair dyes, hair straighteners • Makeup, nail polishes • Shaving preparations • Perfumes and colognes • Toothpastes, mouthwashes • Face and body cleansers, deodorants • Multi-billion dollar industry • Increasingly global industry

4. Cosmetic • Defined in the Federal Food, Drug, and Cosmetic Act (FD&C Act), Section 201 (i) • Articles intended for: • Cleansing • Beautifying • Promoting attractiveness • Altering the appearance ** Excludes “Soap” (defined very narrowly)

5. Drug • Defined in FD&C Act, Section 201 (g) • Articles intended-- • For use in the diagnosis, cure, mitigation, treatment, or prevention of disease • To affect the structure or any function of the body of man or other animals

6. Cosmetics – FDA’s Authority • Cosmetics must not be adulterated or misbranded • The law does NOT provide for FDA pre-market approval • FDA’s authority is post-market only

7. Adulterated Cosmetics Harmful or injurious under labeled or customary conditions of use Formulation Container Contamination Unapproved Color Additive “Coal Tar Hair Dye Exemption” (Sec. 601 (a)) Manufactured or held under “insanitary” conditions Misbranded Cosmetics False or misleading labeling Required information missing or presented improperly Deceptive container Doesn’t comply with 1970 Poison Prevention Packaging Act (Child resistant) Prohibited Under FD&C Act

8. OTC Drug Monograph or product-specific pre-market approval required Pre-market evaluation of safety & efficacy GMP regulations Establishments & products must be registered Serious adverse events must be reported Cosmetic Pre-market approval not required No pre-market clearance of safety or efficacy GMP guidelines only Establishments & products not required to be registered Adverse events not required to be reported OTC Drug vs. Cosmetic

9. Cosmetics Regulations • General (21 CFR Part 700) • Definitions • Requirements for Specific Cosmetic Products • Cosmetic Labeling (21 CFR Part 701) • Voluntary Registration of Cosmetic Product Establishments (21 CFR Part 710) • Voluntary Filing of Cosmetic Product Ingredient Composition Statements (21 CFR Part 720) • Cosmetic Product Warning Statements (21 CFR Part 740)

10. Cosmetics - Challenges • Limited legal authorities • Competing agency priorities • Significant changes in past 5-7 years • Manufacturing more global • Alternatives to animal testing • Increasingly sophisticated technology and complex ingredients • Nanotechnology • “Active” ingredients • Botanicals

11. FDA and International Harmonization • Over-arching goals • Facilitate international trade • Promote mutual understanding • Facilitate exchange of scientific and regulatory knowledge (as law allows) • Accept equivalent standards and compliance/enforcement programs, provided they meet U.S. standards for public health protection • Critical to maintain a high level of public health protection

12. International Harmonization • International Cooperation on Cosmetics Regulation (ICCR) • United States, Canada, European Union and Japan • Industry trade association partners • ISO TC-217 (Cosmetics) and Working Groups • Review draft standards and new work proposals • Working Groups: • Microbiological standards and limits • Packaging, labeling and marking • Analytical methods • Terminology • Good manufacturing practices (GMPs) • Nanomaterials • Sunscreens* (regulated as drugs in the U.S.)

13. FDA’s Tools for Monitoring Compliance and Enforcing Legal Requirements • Inspections • Import entry review and field examinations • Import Alerts • Warning Letters • Seizures • Injunctions

14. FDA’s Risk-Based Enforcement Priorities • Oral care products (esp. low or no alcohol mouthwash) • Eye-area cosmetics • Skin care products • Certain hair care products • Color additives

15. What information does FDA use in developing priorities and evaluating the safety of cosmetics? • FDA’s database of adverse event reports • Historical recall data and inspectional findings • Data from FDA’s Voluntary Cosmetic Registration Program • FDA research, other published scientific literature • Data from other government agencies (such as the NTP) • Findings of the Cosmetic Ingredient Review (CIR) Expert Panel • Findings of other authoritative bodies (such as the IOM) • Data and information from the cosmetic industry, others

16. Adverse EventsOctober 2011 - September 2012 • Total of 381 adverse events reported (over 130 required medical care) • Skin care preparations 43% • Hair straighteners 15% • Hair care preparations (non-coloring) 14% • Hair care preparations (coloring) 13% • Makeup (not eye area) 8% • Eye-area makeup 6% • Personal cleanliness products 4% • Baby products 2% • Oral hygiene, fragrance, suntan products 1% each * Numbers do not add to 100%, some reports involve more than one product

17. FDA’s Initiative to Increase Awareness of Adverse Event Reporting for Cosmetics • Updated web with consumer education information regarding reporting of AERs • “Bad Reaction to Cosmetics? Tell FDA” • Produced a webinar on the importance of reporting AEs involving cosmetics and how to submit a report • Distributed information at meetings of public health officials and organizations • Developing plan for outreach to health professionals providing direct care

18. FDA’s Voluntary Cosmetic Registration Program (VCRP) • Created in the 1970’s as way to gather post-market data • Assists FDA in monitoring the marketplace and assuring cosmetic safety • Electronic submissions began December 2005 • Current status (01/04/2013) • 1671 registered establishments • 1968 firms with product ingredient statements filed • 41179 number of active products

20. Import Refusals • In FY2012 there were a total of 2358 cosmetic import refusals • Reasons for refusal • Drugs/medical devices improperly marketed as cosmetics 19% • Labeling violations 61% • Color additive violations 17% • Poisonous/harmful contaminants, filth/insanitary conditions 3%

21. Import Alerts for Cosmetics • Currently 12 Import Alerts for cosmetics • Subject to “detention without physical examination” • Broad categories for cosmetic-specific alerts include: • Unapproved color additives • Poisonous or deleterious substances • Labeling • Filth/insanitary conditions • Other related Import Alerts: • 17-03 – Amniotic Fluid (Bovine) • 17-04 - Bulk High-Risk Bovine Tissue from BSE Countries • 66-38 - Skin Care Products with Anti-aging Claims • 66-41 - Unapproved New Drugs • 66-74 - Dentifrice Products Containing Diethylene Glycol (DEG)

22. FDA Inspection of Cosmetic Facilities • Facilities of all sizes are subject to inspection • 100-150 U.S. facilities inspected annually • Inspections can be routine or “for cause” • Small number of foreign inspections • Historical focus on manufacturing facilities

23. Microbiological Safety of Cosmetics - Updating and Restructuring FDA Tools • Revise Chapter 23 of FDA’s Bacteriological Analytical Manual (BAM) • Develop/Revise FDA Compliance Guidance • Compliance Policy Guide (CPG) • Compliance Program • Develop Guidance for Industry • Stakeholder input from November 2011 public meeting • Laboratory data and other technical information

24. FDA Cosmetics Research • Method development • Product surveys • Skin penetration and absorption studies • Nanotechnology • Photosciences/Photobiology

25. Laboratory Surveys – Lead in Lipstick • 400 lipsticks on the U.S. market in Spring 2010 • Market Sample: • All the major retailers • Number of lipsticks for each brand → market share • A few lipsticks from niche markets

26. Product Surveys – Lead in Lipstick Conclusions • Lipsticks average ~1 µg Pb/g • 10 out of the 400 lipsticks (< 3 %) had > 3.36 µg Pb/g • 2 out of the 400 lipsticks (0.5 %) had > 5 µg Pb/g • No evidence that levels of lead in lipstick would pose a safety concern

27. Issue - Nanomaterials in Cosmetics Currently Reported Uses • Nanodispersed Systems • Liposomes (nanosomes) • Solid lipid nanoparticles • Nanoemulsions • Other Nanoparticles • Nanocapsules • Polymer systems • Metal Oxide Nanoparticles

28. Recommendations of FDA Nanotechnology Task Force • FDA should issue guidance • Identify issues to consider in assessing safety • Clarify information manufacturers should provide to FDA • Clarify when nanomaterial use may change regulatory status • FDA should evaluate current testing approaches • FDA should assess data needs Draft cosmetics guidance published April 2012 Final guidance currently in clearance Active laboratory research program

29. Issue - Tattoo Inks and Tattoo Pigments Tattoo inks are a mixture of pigments and diluents intended for introduction into the skin FDA traditionally has not exercised its color additive regulatory authority over tattoo inks or tattoo pigments Historically, few adverse events reported Relatively small segment of the population with tattoos The practice of tattooing is regulated by state and local jurisdictions

30. Tattoo InksChanges in the Landscape • Tattoos growing in popularity – 25% of population sports a tattoo! • Reports of adverse reactions linked to tattoos and permanent makeup have steadily increased over past decade • Reactions sometimes hard to control • Recovery can be painful, effects long-lasting

31. Tattoo Inks - FDA’s Future Plans • Gain better understanding • Tattoo ink composition, methods of preservation • Manufacturing practices • All segments of the industry • Continued outreach with all stakeholders • Possible changes in regulatory approach • Standards for finished tattoo inks? • Changes in FDA’s color additive enforcement policy with respect to tattoos?

32. Issue – Cosmetic Labeling Claims When do they cross the line? Cosmetics marketed with drug claims are misbranded 6+ Warning Letters issued in autumn 2012 – generated strong industry and media response Examples of claims: • Kills bacteria and reduces inflammation • Prevents (or heals) scarring and stretch marks • Stimulates the production of “youth proteins” • Boosts the activity of genes • Increases collagen production

33. Switching Gears… … Congressional interest in revisiting FDA’s statutory authorities for cosmetics…

34. Congressional Interest in Revisiting FDA’s Statutory Authorities for Cosmetics • 1970’s • Several hearings • No legislation passed • More recently, several bills introduced but not enacted. Most significant: • 2009 FDA Globalization Act • Covered all FDA-regulated products, with significant new authorities for cosmetics • 2010 Safe Cosmetic Act • Focused on cosmetics • 2011 Safe Cosmetics Act • A re-working of the 2010 bill of the same name

35. Congressional Interest in Revisiting FDA’s Statutory Authorities for Cosmetics • And even more recently… • HR 4262 introduced by Reps. Pallone and Dingell • A re-working of the cosmetics elements in the earlier FDA Globalization Act • HR 4395 introduced by Rep. Lance • Focus on cosmetics

36. Congressional Interest in Revisiting FDA’s Statutory Authorities for Cosmetics • Common Elements in Bills Recently Introduced • Mandatory facility registration • Mandatory product ingredient listing • Mandatory adverse event reporting • Explicit authority to issue regulations addressing good manufacturing practices (GMPs) • Elements With Varying Treatment in Bills Recently Introduced • Safety substantiation/evaluation (products, ingredients, “contaminants”) • Recall authority • Records maintenance and access • Other

37. Congressional Interest in Revisiting FDA’s Statutory Authorities for Cosmetics Will there be renewed activity in 2013? Stay tuned!

38. Contact Information Office of Cosmetics and Colors 5100 Paint Branch Parkway College Park, MD 20740 Phone: 1-240-402-1130 Linda M. Katz, M.D., M.P.H., Director, Office of Cosmetics and Colors Patricia A. Hansen, Ph.D., Deputy Director, Office of Cosmetics and Colors patricia.hansen@fda.hhs.gov

39. Thank You For Your Interest!Questions?