United States: Cosmetics Reform Activity Begins In The 115th Congress

As we have discussed in previous posts, Congress may be moving towards finally enacting some long-awaited cosmetics reform legislation this year. On January 13, Representative Pete Sessions (R-TX) reintroduced his cosmetics modernization bill as H.R.575. The package of reforms was first introduced in November 2015 as the Cosmetic Modernization Amendments of 2015 (H.R.4075).

Overall, the proposed legislation would amend the Federal Food, Drug, and Cosmetic Act with respect to FDA's regulation of cosmetics by creating new requirements such as the registration of manufacturing establishments and the submission of a cosmetic and ingredient statement for each marketed cosmetic. It also would require cosmetic manufacturers, packers, and distributors to report to FDA any serious and unexpected adverse events caused by a cosmetic product. Likewise, cosmetic labels would be required to include contact information for consumers to report such events to the manufacturer or distributor.

Below, we break down in detail pertinent sections of the Sessions bill, as it was introduced in the previous Congress (although reports indicate that the reintroduced version has not been altered significantly).

Section 605 would require every domestic and foreign manufacturer intending to sell a cosmetic in the U.S., and not exempt under another part of the proposed bill, to register with FDA within 60 business days after the first commercial sale of a cosmetic in the U.S. Registration would only be required for the final establishment the manufacturing process. FDA would then issue a "unique cosmetic establishment registration number," and that number would be added to publicly available electronic list of registered establishments.

Section 606 would require every domestic and foreign manufacturer intending to sell a cosmetic in the U.S., and not otherwise exempt, to submit a "cosmetic and ingredient statement" within 60 business days after the first commercial sale of a cosmetic in the U.S. The statement would need to include the manufacturing facility's unique cosmetic establishment registration number and the product's brand name, applicable cosmetic category, and ingredients (including flavors and fragrances), as well as contact information for the person handling the statement's preparation and submission. FDA would be mandated to compile and maintain an up-to-date and publicly available electronic list of submitted cosmetics and ingredients.

Section 607 would require any domestic or foreign manufacturer, packer, or distributor whose name appears on a cosmetic label to submit to FDA adverse event reports no later than 15 business days after the event is first reported to the place of business identified on the label (analogous to what is currently required for drugs and dietary supplements). The bill specifies that a submission of a serious and unexpected adverse event report "shall not be construed as an admission that the cosmetic involved caused or contributed to the adverse event; and may be accompanied by a statement that denies that the report constitutes an admission that the cosmetic involved caused or contributed to the adverse event."

Section 608 would allow FDA to establish "principles and standards for good manufacturing practice for the manufacture of cosmetics." Interesting, the bill states that a cosmetic manufacturer would not be responsible for the good manufacturing practice of its suppliers. This carve-out of responsibility for ensuring downstream members of your supply chain are in compliance with GMPs may be subject to change, as the trend in pharmaceutical and food manufacturing has been towards imposing greater obligations on finished product manufacturers to oversee the quality of all incoming ingredients and product components.

Section 609 would create a list of safe ingredients for manufacturers and distributors to substantiate the safety of their cosmetic products. The list ranges from color additives to fragrance ingredients previous recognized as generally safe by various authorities.

Section 610 would establish a "National Cosmetic Regulatory Databank" within FDA to contain information submitted to the Agency under other sections of the bill, and other pertinent information.

Representative Sessions's bill stands in contrast to the Personal Care Products Safety Act, cosponsored by Senators Dianne Feinstein (D-CA) and Susan Collins (R-ME). We wrote about the PCPA when it was first introduced in May 2015, and more recently in October 2016.

While both bills give FDA a greater ability to ensure cosmetic product safety in the marketplace, Collins and Feinstein's bill would allow FDA to collect annual user fees from companies, unless they have an average gross annual sale of less than $500,000 for the three-year period preceding the fee collection for a specific fiscal year. And although both bills call for manufacturer registration with FDA, compliance with GMPs, and the submission of ingredient statements, Collins and Feinstein's bill would require FDA to review at least five cosmetic ingredients for safety every year. It also would create new authority for FDA to order mandatory recalls of unsafe cosmetic products. Moreover, there is a discrepancy between the two bills when it comes to the proposed definition of a "cosmetic." The Sessions bill provides for a definition that would incorporate topical products that are able to temporarily alter the structure and function of human skin – thus expanding the existing Federal definition of a "cosmetic" – whereas the Collins and Feinstein bill makes no change to the current statutory definition, such that such topical treatments would continue to be treated as "drugs" by FDA based on their claimed effects on structure and function.

Finally, the bills also differ in terms of industry support. Without any mention of industry user fees, the Sessions bill is backed by smaller cosmetics companies, mainly represented by the Independent Cosmetic Manufacturers and Distributors (ICMD). On the other hand, Collins and Feinstein's bill is backed by heavyweights such as the American Cancer Society, Johnson & Johnson, Procter & Gamble, Revlon, Estee Lauder, and L'Oréal. The Personal Care Products Council (PCPC), the trade association representing most of these national brands, issued a statement on January 18 in support of bipartisan reforms to the current cosmetics framework, but it did not call out any single piece of legislation by name. PCPC has previously said that Federal preemption language in any new cosmetics law would be critical in order to garner the association's support.

We will be keeping track of both these bills and the progress of cosmetics reform negotiations during the 115th Congress.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
 
In association with
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration
Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:
  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.
  • Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.
    If you do not want us to provide your name and email address you may opt out by clicking here
    If you do not wish to receive any future announcements of products and services offered by Mondaq you may opt out by clicking here

    Terms & Conditions and Privacy Statement

    Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

    Use of www.mondaq.com

    You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.

    Disclaimer

    Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

    The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.

    Registration

    Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

    • To allow you to personalize the Mondaq websites you are visiting.
    • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
    • To produce demographic feedback for our information providers who provide information free for your use.

    Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

    Information Collection and Use

    We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

    We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

    Mondaq News Alerts

    In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.

    Cookies

    A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

    Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

    Log Files

    We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.

    Links

    This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

    Surveys & Contests

    From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.

    Mail-A-Friend

    If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.

    Emails

    From time to time Mondaq may send you emails promoting Mondaq services including new services. You may opt out of receiving such emails by clicking below.

    *** If you do not wish to receive any future announcements of services offered by Mondaq you may opt out by clicking here .

    Security

    This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

    Correcting/Updating Personal Information

    If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

    Notification of Changes

    If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

    How to contact Mondaq

    You can contact us with comments or queries at enquiries@mondaq.com.

    If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.

    By clicking Register you state you have read and agree to our Terms and Conditions