Suspected Economically Motivated Adulteration of FDA-Regulated Products Cosmetics and Personal Care Products John E. Bailey Executive Vice President - Science Personal Care Products Council 1

Economically Motivated Adulteration of FDA-Regulated Products FDA proposes a working definition of EMA as the fraudulent, intentional substitution or addition of a substance in a product for the purpose of increasing the apparent value of the product or reducing the cost of its production, i.e., for economic gain. 2

Economically Motivated Adulteration of FDA- Regulated Products EMA includes dilution of products with increased quantities of an already-present substance (e.g., increasing inactive ingredients of a drug with a resulting reduction in strength of the finished product, or watering down of juice) to the extent that such dilution poses a known or possible health risk to consumers, as well as the addition or substitution of substances in order to mask dilution. 3

Economically Motivated Adulteration of FDA- Regulated Products Economically Motivated Adulteration may arise from the following sources: – Dilution of an ingredient to reduce the costs of manufacturing. – Substitution of one ingredient for another cheaper ingredient without changing the ingredient declaration on the product label. – Intentional omission of an ingredient that is otherwise included in the ingredient declaration on the product label.

Economically Motivated Adulteration of FDA- Regulated Products Cosmetic products that are sold at retail for use by consumers are required to bear a full declaration of ingredients used in the formulation of the product. Cosmetics present only a minimal risk of causing harm to the consumer. Most products are applied topically and do not penetrate the skin. 5

Economically Motivated Adulteration of FDA- Regulated Products Some products, such as lipsticks, mouth washes, breath fresheners and toothpastes, are subject to incidental oral exposure. A very limited number of products are actually introduced into the body (i.e., vaginal douches for personal hygiene cleansing purposes is classified as a cosmetic). 6

Economically Motivated Adulteration of FDA- Regulated Products Economically Motivated Adulteration may potentially have an adverse health impact if: – The user is allergic to an ingredient that is not declared on the label (a very rare event and of low probability). – The omission or substitution of an ingredient causes the preservative system to fail and the product becomes contaminated with harmful microorganisms. 7

Economically Motivated Adulteration of FDA- Regulated Products Identified instances of EMA in the area of cosmetics are extremely rare and have not resulted in any known harm to human health. Most EMA has been associated with counterfeit products. Individual companies and product retailers take steps to reduce the occurrence of EMA and counterfeit products. 8

Economically Motivated Adulteration of FDA- Regulated Products The Personal Care Products Council has taken a number of steps to help companies set up systems that will minimize the opportunity for EMA to occur: – Worked within ISO TC-217 to develop international Good Manufacturing Practices standard (ISO International Standard 22716). – Developed and published a Quality Assurance and GMP Guideline that helps ensure proper control of raw materials and manufacturing/packaging. 9

Economically Motivated Adulteration of FDA- Regulated Products The Personal Care Products Council has taken a number of steps to help companies set up systems that will minimize the opportunity for EMA to occur: – Developed and distributed a Raw Material Information Form as a tool to promote uniformity in identification and characterization for ingredients. – Published a Product Security Guideline for the cosmetics industry. – Worked with FDA and Customs on how to control and spot counterfeit products. 10

The Personal Care Products Council believes the following indicators might be used to detect potential EMA: Products that are marketed outside of established retail channels or outlets (i.e. marketing on the internet outside of the established retail channels). Failure of ingredients to meet established identity and chemical specifications. Economically Motivated Adulteration of FDA- Regulated Products 11

Economically Motivated Adulteration of FDA- Regulated Products Products that do not bear valid lot codes. Product performance. Product appearance. Packaging appearance or defects. 12