On April 20, 2015, Senators Dianne Feinstein (D-Calif.) and Susan Collins (R-Maine) introduced the Personal Care Products Safety Act (S. 1014). This post provides a summary of keys sections of the proposed bill with a comparison to existing law.
According to the press release issued by Senator Feinstein’s office, the S. 1014 has the support of numerous industry trade and consumer groups, including the following:
- Personal Care Products Council (a trade association representing more than 600 companies in the industry)
- Johnson & Johnson (brands include Neutrogena, Aveeno, Clean & Clear, Lubriderm, Johnson’s baby products)
- Procter & Gamble (brands include Pantene, Head & Shoulders, Clairol, Herbal Essences, Secret, Dolce & Gabbana, Gucci, Ivory, Cover Girl, Olay, Sebastian Professional, Vidal Sassoon)
- Revlon (brands include Revlon, Almay, Mitchum)
- Estee Lauder (brands include Estée Lauder, Clinique, Origins, Tommy Hilfiger, MAC, La Mer, Bobbi Brown, Donna Karan, Aveda, Michael Kors)
- Unilever (brands include Dove, Tresemme, Lever, St. Ives, Noxzema, Nexxus, Pond’s, Suave, Sunsilk, Vaseline, Degree)
- L’Oreal (brands include L’Oréal Paris, Lancome, Giorgio Armani, Yves Saint Laurent, Kiehl’s, Essie, Garnier, Maybelline-New York, Vichy, La Roche-Posay, The Body Shop, Redken)
- Environmental Working Group
- Society for Women’s Health Research
- National Alliance for Hispanic Health
- Healthy Women
Notably, this is not the first cosmetics safety bill to be introduced in recent years–and, indeed, many of the provisions of this bill were included in prior proposed bills. With such broad support from industry and consumer groups, as well as the fact it is a bipartisan bill, it would seem this bill may be more likely to pass– though I suspect it will likely undergo significant revisions.
The following is a table summarizing the key points of this bill in its current form comparing it existing law:
|S. 1014 Sections||Proposed Bill||Existing Law|
|Sec. 101 Registration of cosmetics facilities and ingredient statements||Requires registration of existing cosmetics facilities (factory, warehouse, or establishment (including a factory, warehouse, or establishment of an importer) that manufactures, processes, packs, or holds cosmetic products or cosmetic formulations, or any other entity whose name and address appear on the label of a cosmetic product. Among other things, excludes domestic manufacturers with less than $100,000 in gross annual sales of cosmetic products.Requires the “responsible person” to submit the cosmetic ingredient statement for each cosmetic product. For existing products, submission due by Dec. 1, 2015. For new products, due within 60 days of first marketing.In filing the ingredient statement, the responsible person must attest that the safety of the product and each ingredient has been substantiated.
After notice and opportunity to respond, if FDA determines that a cosmetic formulation or product has a “reasonable probability of causing serious ” harm, it may suspend the ingredient statement and the facility registration if there is reason to believe the problem affects multiple products in that facility.
|No registration requirement. FDA currently has a voluntary registration program.|
|Sec. 102 FDA Ingredient Review / Approval||Beginning in 2016, FDA must evaluate a minimum of five ingredients per year to determine safety and appropriate use. (see below) A public comment period of 60 days must be provided in the process.Beginning fiscal year 2017, the FDA shall annually select and complete a safety review of “at least 5” cosmetic ingredients or non-functional constituents that were not reviewed in the prior 3 years “from a list determine in consultation with industry and consumer groups.Provides for the establishment of a Cosmetics Safety Advisory Committee which shall advise the FDA of ingredients to be considered for review.
FDA’s final order on an ingredient shall include conditions of use, permitted tolerances, limits on the amount or concentrations, and warnings, including warnings related to use by children, pregnant women, or other vulnerable populations.
The responsible party must before first distributing the product for sale, make a written determination that the product is safe under the conditions of use recommended in the labeling of the product.
Requires responsible party to maintain records documenting the safety determination.
|With the exception of color additives, no mandatory review of ingredients. Also, Regulations restrict or prohibit the use of 9 ingredients.No requirement that cosmetics products safety be evaluated. Instead, if safety has not been evaluated, the statement “Warning– The safety of this product has not been determined” must be conspicuously located on the principal display panel.|
|Sec. 103 GMPs for Cosmetics||Within 18 months of enactment of the bill, FDA shall develop and implement through regulation standards for cosmetic good manufacturing practices. For large businesses, GMP requirements take effect beginning 180 days of the final regulations. For small businesses, the GMP requirement shall take effect beginning 2 years after promulgation.||No mandatory GMPs. FDA issued a draft GMP guidance in 2014.|
|Sec. 104 Adverse event reports||Requires the reporting of serious adverse event to be reported within 15 days of receiving the information concerning an adverse event. “Adverse events” are those that result in death, a life threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, congenital anomaly or birth defect, or significant disfigurement, including serious and persistent rashes and infections.||No requirement to report adverse events, although the FDA encourages their reporting.|
|Sec. 105 Records inspection & Recall Authority.||Gives FDA authority to inspect records required to maintained which document the safety determination of cosmetic products.Gives FDA authority to request the voluntary recall of certain personal care products that threaten consumer safety. If the responsible party refuses to or does not voluntarily cease distribution, FDA may issue an order mandated the recall. Upon the issuance of the order, FDA must provide the responsible party an opportunity for an informal hearing to be held within 2-days after issuance of the order. After the hearing, FDA may either amend the order to require the recall or other appropriate action, specify a timetable for the recall, require periodic reports to FDA describing the recall’s progress, and provide notice to consumers via press release. Alternatively, FDA may vacate the recall order.||No authority to order recalls. Instead, FDA can suggest recalls but must seek court intervention if the company refuses.|
|Sec. 106 Labeling||Gives FDA authority to require specific labeling of products that include ingredients not appropriate for children and those that should be for Professional Use Only.Internet websites offering cosmetics for sale shall provide the same information required on the packaging of the cosmetics, and the warnings shall be prominently and conspicuously displayed.Label must contain the domestic telephone or electronic contact information consumers may use to report adverse events.||No specific warning requirements beyond the warning that the safety of a product has not been determined.Address of the place of business of the manufacturer, packer, or distributor including the street address, the city, state, and ZIP code.|
|Sec. 108 Animal Testing Alternatives||FDA shall encourage alternative testing methods to animal testing and within 3 years the FDA shall issue a guidance on the acceptability of scientifically reliable and relevant alternatives to animal testing.|
As mentioned in the table, under S. 1014, the first set of chemicals (which are likely not a surprise to most safe cosmetics advocates) to be reviewed in 2016 are:
- Diazolidinyl urea (a formaldehyde used as a preservative in a wide range of products including deodorant, shampoo, conditioner, bubble bath and lotion)
- Lead acetate (used as a color additive in hair dyes)
- Methylene glycol/formaldehyde, which is used in hair treatments
- Propyl paraben, which is used as a preservative in a wide range of products including shampoo, conditioner and lotion
- Quaternium-15, which is used as a preservative in a wide range of products including shampoo, shaving cream, skin creams and cleansers
Obviously, these new oversight activities will be costly, so the bill also authorizes the FDA to collect user-fees from personal care products manufacturers similar to what is done for drugs and medical devices. The bill will also result in significant costs to cosmetic manufacturers– and is likely to be felt hardest by smaller companies. Although the bill provides for an exemption from facility registration for “small businesses,” other aspects of the bill are enforceable against “small businesses” — though at different time frames and in some instances to a lesser extent.
I suspect the hardest hit will be those companies not already engaging in extensive safety assessments (such as those not already selling into the EU) as well as those small businesses without facilities that would qualify under the standards for good manufacturing practices. Such companies should review FDA’s draft guidance for cosmetic good manufacturing practices issued in 2014 (available here).
I will continue to write on this topic as the bill moves through Congress and provide updates on its revisions. Do you have an opinion on this bill? If so, leave your thoughts and comments below.