American Bar Association
Section of Science & Technology Law: Food, Cosmetics and Nutraceuticals

Section of Science & Technology Law:
Food, Cosmetics and Nutraceuticals

About the Committee

The mission of this Committee is to keep its members educated and informed on legal issues relating to the burgeoning industries of foods, dietary supplements, nutraceuticals, medical foods, and cosmetics. Nutraceuticals is a marketing term, not a regulatory one, and includes food and supplement products that claim to provide health benefits beyond their basic nutritional value. Medical food is a distinct category of food products that are administered under the supervision of a physician, and which are intended for the specific dietary management of a disease or condition. The FDA and federal laws regulate the food, dietary supplement, and medical food categories quite differently, posing traps for unwary clients and their lawyers. Cosmetics fall under a different regulatory scheme, with "cosmeceuticals," yet another marketing derived category, inhabiting the murky regulatory line between cosmetics and drugs. Beyond FDA, relevant considerations include FTC's substantiation rules, the Lanham Act, state laws, and potential class actions.

Hot Topics

July 21, 2015 presentation (by Nazish Shabbir and Kelly Dawson on behalf of Laurie Henry and Madeleine McDonough):

International Cooperation on Cosmetics Regulation (ICCR)

ICCR is a volunteer international group of cosmetic regulatory authorities from Brazil, Canada, the U.S., and the E.U. The organization meetings annually to discuss common issues on safety and regulation. FDA will be holding a public meeting on 9/10/15 to receive input from the public on the various topics pertaining to regulation of cosmetics to help the agency prepare for the upcoming ICCR meeting in Brussels, Belgium on November 4-6. ICCR’s purpose is to provide a multilateral framework to maintain and enable the highest level of global consumer protection by working towards promoting regulatory convergence, while minimizing barriers to international trade. The organization sets out to “harmonize” regulations, facilitate common goals like promotion of international trade by removing regulatory obstacles, exchange scientific and regulatory knowledge, and develop equivalent compliance and enforcement standards to protect the public health. FDA’s goals in participating in ICCR include: accepting equivalent standards, compliance activities, and enforcement programs of other countries, if they meet FDA’s level of public health protection; avoiding lowering public health protection afforded by US law; promoting mutual understanding; and facilitating scientific and regulatory knowledge with foreign countries to the extent allowed by law.

ICCR has both members and observes. Current members include the following regulatory authorities: Anvisa (Brazil), Health Canada, European Commission, Japan Ministry of Health Labor and Welfare and FDA. Industry participants include: The Canadian Cosmetic, Toiletry and Fragrance Association; China Association of Fragrance, Flavor, and Cosmetic Industry; Cosmetics Europe, Personal Care Products Council (PCPC); Independent Cosmetic Manufacturers and Distributors (ICMAD); and the Japan Cosmetic Industry Association.

Topics for this year’s conference include: allergens, microbial limits, international standards processes, and the white paper on the importance of product preservation.

FDA Warning Letters

FDA warning letters continue to be a “hot” issue for cosmetics manufacturers. Between 2012 and the present, FDA issued a number of warning letters to cosmetics companies relating to product claims. These letters target performance claims in product packaging and marketing literature that the FDA considers “drug-like” or suggestive of an intent to “diagnose, mitigate, treat, or prevent disease, or to affect the structure or function of the body” – things only a regulated drug is permitted to do. These warning letters sparked an uptick in unfair and deceptive trade practices class action lawsuits, with plaintiffs claiming that many of the targeted product claims were false or overstated. Recently, the FDA has set its sights on a new cosmetics target – products such as dermabrasion pens and injectable fillers – which the FDA determined are intended to “affect the structure or function of the body,” and are therefore medical devices, subject to pre-marketing regulation.

During the call, one of the committee members referenced a medical devices resolution that was submitted and withdrawn. I believe the member stated that it proposed precluding punitive damages in lawsuits involving a regulated medical device. He suggested there may some overlap with our “hot topic,” but I was not familiar with the proposed resolution as I do not regularly attend the ABA committee meetings. I agree, however, that there is likely overlap, and would be interested to learn more about (1) the proposed resolution; and (2) the reasons for withdrawal. Would you mind forwarding this information, or having the Committee member contact me personally to discuss?

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Our Leadership


Berman, Jonathan
Fuson, John

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Committee Events

Life Sciences Legal Summit

February 27, 2014
San Francisco, CA

- Features preeminent attorneys, industry figures, leading trial and appellate lawyers, and in-house counsel from companies including: Pfizer, Genentech, Jazz Pharmaceuticals, and BioMarin Pharmaceutical

-Learn from federal and state courts judges as they give their thoughts and insights on the most compelling issues in mass tort litigation issues faced by life science companies

-Hear the latest on cutting-edge legal and technical issues relevant to those practicing in pharmaceutical, medical device, and biotechnology arenas

- Network with other attendees and industry professionals at a Joint Networking Reception

Brown Bag Lunch Series: Food Import Management

Details TBA.

Food & Supplements Fourth Annual Workshop

June 5, 2014
Cargill, Inc.| Minneapolis, MN

Please mark your calendars (and tell your colleagues to mark their calendars) for this year's ABA Annual Food & Supplements Workshop on June 5 at Cargill's corporate headquarters outside of Minneapolis. Shirley Boyd of Cargill, Scott Elder of Alston & Bird and I are co-chairing the workshop, and we're pleased to joined by a great group of speakers, including experienced practitioners, FDA representatives, and in-house industry lawyers. Topics include:
- Emerging Issues: Surveying the Regulatory and Litigation Horizon
- Ethical Issues Arising from Governmental Investigations of Food Companies
- FSMA New Developments
- Consumer Fraud Class Actions - Litigation and Settlement Strategies
- Anatomy of a Recall
- Litigation Risks: How In-House and Outside Counsel Can Work Together to Identify and Preemptively Address Potential Lawsuits

Registration will open soon, and we're looking forward to another great conference!

If your firm is interested in sponsoring this Workshop, please let me know. The deadline is March 21st or as soon as the slots fill up. Sponsorship levels are:
- Breakfast - $400
- Break - $300
- Lunch - $600
- Reception - $900
Sponsors are recognized in the conference brochure, which is widely viewed through the ABA website and list serves, and through signage at the event sponsored. It's great exposure (and a great value) for your firm! All sponsors are subject to ABA approval.

Hope to see you in June!

Section Events

Modified by Jessika Tuazon on October 9, 2015

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