COSMETICS REFORM EXPLAINED

COSMETICS REFORM EXPLAINED

2 BACKGROUND/ INTRO

3 Background/Intro At the Johnson & Johnson & Johnson Family of Consumer Companies, we recognize that consumer confidence is more than a formula, which is why we support the modernization of a law that will update the U.S. Food and Drug Administration s (FDA) regulatory authority over cosmetics and personal care products, reinforcing peace of mind to consumers. The Johnson & Johnson Family of Consumer Companies supports the Personal Care Products Safety Act by Senators Feinstein (D-CA) and Collins (R-ME) and we welcome the opportunity to work with Congress and U.S. FDA to better serve consumers and the public health. Our support for personal care products safety reform is characterized in three principles. We believe that in order to best serve consumers, families, healthcare professionals, as well as our employees and the public, we need a regulatory framework for cosmetics that is consistent, reflects modern science and advancements in personal care product technology. We recognize that any company that makes cosmetics or personal care products has a responsibility to ensure its products are safe and that the U.S. FDA oversight is an important confirmation of product safety. For that reason, we believe the U.S. FDA is the best authority for determining and enhancing the health and well-being of American consumers by regulating the safety of ingredients and enforcing standards for cosmetics and personal care products. Nothing is more important to us than the safety of consumers and maintaining their trust in our products. Our support for personal care product safety reform is aimed at removing consumer doubt about the safety of these products and reassuring consumer s peace of mind everywhere our products are sold. Enhancing the U.S. FDA s regulatory authority would allow the agency to keep pace with innovative technologies, consumer expectations, and provide added protections for the public health.

4 Cosmetics v. Personal Care Products? WHAT S THE DIFFERENCE?

5 According to the Federal Food, Drug, & Cosmetic Act defines cosmetics by their intended use, as: articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance According to the U.S. FDA, the term personal care product is not defined in the regulations. In fact, people often use the term personal care products to refer to everyday products like shampoos, facial cleansers, toothpaste, or moisturizers. While the term cosmetics refers to color cosmetics, such as make up, mascaras, and lipsticks, both personal care products and color cosmetics are regulated as cosmetics by the FDA. If some of these products make a therapeutic claim, they then are regulated as drugs, like acne creams, sunscreens, and even antiperspirants. It is possible that some personal care products meet the definition of both a cosmetic and a drug. For example, a mouthwash containing fluoride is a cosmetic/drug combination, as is anti-dandruff shampoo, face wash containing salicylic acid to treat acne or anti-itch creams that contain hydrocortisone. These products that we commonly find in the health and beauty sections of drug and department stores are technically cosmetics, but the term personal care product is used to define the broader category of products.

6 WHAT WE SUPPORT

7 What We Support Johnson & Johnson Family of Consumer Companies is committed to working with regulatory bodies, policy makers, industry, healthcare professionals and consumers to continue improving cosmetic regulations to best serve the public health and give consumers confidence. We support a federal framework for the regulation of personal care products that will significantly update U.S. cosmetic regulation that was originally written more than 70 years. WE SUPPORT LEGISLATION THAT WOULD:»» require manufacturing facility registration»» require manufacturers to report adverse events to the FDA»» create basic manufacturing practice requirements»» grant the FDA mandatory recall authority»» grant the FDA access to ingredient and product safety records»» require complete label information on products sold online»» require the FDA to evaluate at least five ingredients a year and issue guidance on their safety and appropriate use WE ALSO SUPPORT THE U.S. FDA AUTHORITY TO DETERMINE THE SAFETY OF COSMETIC INGREDIENTS. We advocate for legislation that specifies FDA standards on individual ingredients would preempt action on those same ingredients at the state level, in order to avoid conflicting regulations across the country.

8 CURRENT REGULATIONS

9 Current Regulations How are personal care products in the US Regulated today? Since 1938, the Federal Food, Drug, and Cosmetic Act has provided the FDA with the authority to regulate cosmetics and personal care products. Currently, the U.S. regulatory framework is a complex system of federal & state government regulations, various court rulings, scientific guidelines, independent safety reviews and industry-self-regulation. There are essentially three main components to the current US cosmetic regulatory system: US FDA In 1938, Congress passed the Federal Food, Drug, and Cosmetic Act, giving authority to the U.S. FDA to oversee the safety of food, drugs, and cosmetics. FDA s authority over cosmetics is different from their authority over other products they regulate, such as pharmaceutics or medical devices. Cosmetic Ingredient Review The Cosmetic Ingredient Review (CIR) was established in 1976 by the industry trade association with the support of the U.S. Food and Drug Administration and the Consumer Federation of America. The CIR is the industry-funded panel that ensures the safety of the ingredients used in cosmetics today. Its meetings are open to the public and its findings and minutes are publicly available on its website. Consumer Commitment Code In 2007, the Personal Care Products Council adopted the Consumer Commitment Code for the cosmetic industry. The code builds on the safety standards published by the CIR and adds new responsibilities including reporting of the Safety Information Summary Program that makes cosmetic product and ingredient safety information readily available to the FDA upon request, and adverse event reporting to the FDA.

10 OUR SAFETY STANDARDS

11 Our Safety Standards We hold that personal care products are among the safest category of products regulated by the U.S. FDA. The agency already has authority to ensure the safety of personal care products today, but clarifying that authority and the information it receives provides additional protection and confidence for the public. While the Federal Food, Drug, and Cosmetic Act regulates our products, at Johnson & Johnson Family of Consumer Companies, our products are designed to meet the strictest safety standards wherever our products are sold. We also follow scientific and evidence-based guidelines where best practices are encouraged in complementary fashion to existing regulatory and legal requirements.

12 At the Johnson & Johnson Family of Consumer Companies, we meet and exceed standards for developing personal care products and here are a few examples of how we do it: We take responsibility in ensuring the safety of all our products, taking them through our five-level safety assurance process. We conduct specific tests to demonstrate the safety of individual products and their ingredients. We regularly share our safety information with health authorities like the US FDA. We register our products with US FDA. Most importantly, we voluntarily report adverse events and make those reports available to the US FDA.

Our heritage as a healthcare company inspires us to maintain the highest standards and approach developing personal care products from a scientific & evidence-based perspective. 13

14 CLOSING

15 Closing Johnson & Johnson Family of Consumer Companies is committed to working with regulatory bodies, policy makers, industry, healthcare professionals and consumers to continue improving cosmetic regulations to best serve the public health and give consumers confidence. We support the Personal Care Products Safety Act sponsored by Senators Diane Feinstein (D-CA) and Susan Collins (R-ME) and we urge Congress to pass this legislation.

This information is intended for use by residents of the United States only.