“Personal Care Products Safety Act” S. 1014: Proposed Legislation that will Have a Huge Impact on the Cosmetics Industry if Enacted

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:

  1. Diazolidinyl urea (a formaldehyde used as a preservative in a wide range of products including deodorant, shampoo, conditioner, bubble bath and lotion)
  2. Lead acetate (used as a color additive in hair dyes)
  3. Methylene glycol/formaldehyde, which is used in hair treatments
  4. Propyl paraben, which is used as a preservative in a wide range of products including shampoo, conditioner and lotion
  5. 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.

11 Comments

  1. Thank you for sharing this information. This could be huge, and potentially detrimental to small companies. Do you know of the timing for when this may or may not become law?

    Thanks!
    Tommi

    Thomasina Hutchins

    Product Development Manager
    Aura Cacia, a Brand of Frontier Co-op
    3021 78th Street
    Norway, IA 52318

    319.227.7996 ext. 1164

    thomasina.hutchins@frontiercoop.com

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    1. Thank you for your comment Thomasina. The bill was only just introduced on Monday, so it will have to go through the legislative process which can be a long process. On Monday, the bill, S. 1014 was read twice and referred to the Committee on Health, Education, Labor, and Pensions. Worth noting is that prior cosmetics safety bills either never made it of the House or Senate floor into committee, or never made it out of committee. Once out of Committee, where it may be amended, it will have to be voted on in the Senate. If it passes the Senate it will then go through the House.

      If passed this legislative season, the various requirements of the Act go into effect at different times. For example, the requirements regarding safety of the finished product goes into effect 180 days after passage of the Bill.

      The requirements pertaining the GMPs go into effect 180 days (for large companies) or 2 years (for small companies) after the FDA promulgates regulations for the good manufacturing practices. Although the FDA issued a draft guidance for cosmetic GMPs last year, it will be subject to the administrative procedure process, including a public comment period. Per the Bill, FDA must issue a final rule within 3 years after the enactment of the Bill.

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  2. The impact on the smaller marketers will be very significant. What will be the consequences to the private labelers that service so many marketers?
    It should be noted that the requirement to disclose formulations is by “a range of possible amounts for each ingredient”, a much more tolerable situation for marketers than precise amounts. Also, that the exemption from listing a “non-functional constituent” would continue.
    The safety substantiation requirement by individual ingredient “and appropriate safety substantiation of the finished product beyond the safety substantiation of individual ingredients and consideration of the combination of ingredients” will pose a significant time and monetary obstacle to smaller marketers.

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    1. Thank you for your question Paul. Under the Food, Drug, and Cosmetic Act, a cosmetic is defined as an article applied to a person’s body intended to promote attractiveness, beautify, cleanse, or alter the appearance. Generally, perfume falls under this definition. If, however, the perfume is intended to have therapeutic uses, e.g., to sooth headaches, help a person sleep, etc., then the perfume may also arguably be a drug. For further discussion, see the blog post “Cosmetic Drug? How Puffery May Cause your Product to be a Drug

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  3. I have been making handmade soap for the last 12 years. The ingredients in handmade soap are more than likely found in your pantry (olive oil, coconut oil, sunflower oil, etc) and have already been determined to be safe for use. In fact, they are benign. This bill is nothing more than an attempt to squeeze out competition. If people wanted to use the chemical concoctions these large corporations call body cleansers, then the handmade soap industry wouldn’t be so large. This leaves people with NO choice, as your average handmade soap business could not afford to comply. Nor, do most have the manpower. What’s next, grandma’s homemade pie? Oh, wait. She’s already been on the chopping block. So much for a free country.

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  4. This legislation requires every cosmetic manufacturer to register with the FDA. Regarding registered facilities, it states in Sec 605.2.I that “An assurance that the Food and Drug Administration will be permitted to inspect such facility at the times and in the manner permitted by this act”. This means that the FDA can come into your home and inspect it whenever they feel like it! It is not just about the money or fees. They will be inspecting our homes! That will deny us our 4th Amendment Rights against illegal search. They will be searching for anything that does not comply with their mandate.

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