Posted: 28 Apr 2015 07:55 PM PDT
By Riëtte van Laack –
On Monday April 20, 2015, Senators Dianne Feinstein (D-Calif.) and Susan Collins (R-Maine) introduced the Personal Care Products Safety Act (S. 1014). The almost 100-page bill would significantly expand FDA's authority over cosmetic products sold in the United States. The bill addresses a range of issues including registration of facilities, registration of products, mandatory recall authority, adverse and serious adverse event reporting, good manufacturing practices, and user fees. The bill’s drafters seem to have drawn from existing provisions in the FDC Act applicable to nonprescription drugs, such as establishment and product registration requirements, and from certain provisions applicable to foods, such as the provision giving FDA mandatory recall authority.
Interestingly, the requirements for adverse event reporting exceed requirements applicable to non-prescription drugs. Under the proposed bill, companies must report “serious” adverse events (i.e., death; life-threatening experience; inpatient hospitalization; persistent or significant disability or incapacity; congenital anomaly or birth defect; or significant disfigurement, including serious and persistent rashes and infections; or events that require a medical or surgical intervention to prevent any of these outcomes) within 15 business days. Companies also must report all nonserious adverse events (broadly defined as health-related events that are adverse) in an annual report (this report may not include complaints about efficacy). Presumably to facilitate contacting the cosmetic company, cosmetic labels must include a domestic phone number or electronic contact information. A domestic address is not an option.
FDA’s mandatory recall authority would be limited to instances in which the use of or the exposure to a cosmetic is likely to cause serious adverse health consequences or death and the company has refused to voluntarily recall the product.
For products that are both non-prescription drugs and cosmetics, and, therefore, are subject to the requirements for non-prescription drugs as well as cosmetics, compliance with the requirements for nonprescription drugs which are “substantially similar” to the requirements under the proposed law, will be deemed compliance with the new law. The law does not define “substantially” similar and further clarification will undoubtedly be required.
The bill also proposes to task FDA with investigation of at least five different cosmetic ingredients for safety each year. The ingredients FDA would study during the first year after enactment are: propylparaben (a common cosmetic preservative); methylene glycol (a formaldehyde-releasing chemical previously used in some hair-straightening treatments); diazolidinyl urea (a preservative used in various cosmetics including shampoo and conditioner), Quaternium-15 (a preservative used in shaving cream, skin creams, etc.) and lead acetate (used in hair dye). There is no indication that FDA would be able to rely on the current industry-sponsored Cosmetic Ingredient Review (CIR).
Implementation of these proposed amendments to the FDC Act, including development of cosmetic GMP regulations and ingredient review, is estimated to cost $20.6 million per year. These costs would be covered by registration fees. The bill proposes to link the registration fee to the gross annual sales from cosmetics of the registered companies with fees ranging from $250 (gross sales from $500,000 to $2.5 million) to $1.1 million (gross sales of $5 billion (i.e., $5,000,000,000) or more).
This bill is not the first effort to provide FDA with additional authority regarding cosmetics. However, it certainly is the most comprehensive.
On Monday April 20, 2015, Senators Dianne Feinstein (D-Calif.) and Susan Collins (R-Maine) introduced the Personal Care Products Safety Act (S. 1014). The almost 100-page bill would significantly expand FDA's authority over cosmetic products sold in the United States. The bill addresses a range of issues including registration of facilities, registration of products, mandatory recall authority, adverse and serious adverse event reporting, good manufacturing practices, and user fees. The bill’s drafters seem to have drawn from existing provisions in the FDC Act applicable to nonprescription drugs, such as establishment and product registration requirements, and from certain provisions applicable to foods, such as the provision giving FDA mandatory recall authority.
Interestingly, the requirements for adverse event reporting exceed requirements applicable to non-prescription drugs. Under the proposed bill, companies must report “serious” adverse events (i.e., death; life-threatening experience; inpatient hospitalization; persistent or significant disability or incapacity; congenital anomaly or birth defect; or significant disfigurement, including serious and persistent rashes and infections; or events that require a medical or surgical intervention to prevent any of these outcomes) within 15 business days. Companies also must report all nonserious adverse events (broadly defined as health-related events that are adverse) in an annual report (this report may not include complaints about efficacy). Presumably to facilitate contacting the cosmetic company, cosmetic labels must include a domestic phone number or electronic contact information. A domestic address is not an option.
FDA’s mandatory recall authority would be limited to instances in which the use of or the exposure to a cosmetic is likely to cause serious adverse health consequences or death and the company has refused to voluntarily recall the product.
For products that are both non-prescription drugs and cosmetics, and, therefore, are subject to the requirements for non-prescription drugs as well as cosmetics, compliance with the requirements for nonprescription drugs which are “substantially similar” to the requirements under the proposed law, will be deemed compliance with the new law. The law does not define “substantially” similar and further clarification will undoubtedly be required.
The bill also proposes to task FDA with investigation of at least five different cosmetic ingredients for safety each year. The ingredients FDA would study during the first year after enactment are: propylparaben (a common cosmetic preservative); methylene glycol (a formaldehyde-releasing chemical previously used in some hair-straightening treatments); diazolidinyl urea (a preservative used in various cosmetics including shampoo and conditioner), Quaternium-15 (a preservative used in shaving cream, skin creams, etc.) and lead acetate (used in hair dye). There is no indication that FDA would be able to rely on the current industry-sponsored Cosmetic Ingredient Review (CIR).
Implementation of these proposed amendments to the FDC Act, including development of cosmetic GMP regulations and ingredient review, is estimated to cost $20.6 million per year. These costs would be covered by registration fees. The bill proposes to link the registration fee to the gross annual sales from cosmetics of the registered companies with fees ranging from $250 (gross sales from $500,000 to $2.5 million) to $1.1 million (gross sales of $5 billion (i.e., $5,000,000,000) or more).
This bill is not the first effort to provide FDA with additional authority regarding cosmetics. However, it certainly is the most comprehensive.
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