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Volume XI, Number 57

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Citizen’s Petition Filed for FDA Pathway to Legally Market Supplements With CBD

On June 17, 2020, The Council for Responsible Nutrition (CRN) filed a Citizen’s Petition with the Food and Drug Administration (FDA) requesting that the FDA establish a regulatory pathway to legally market dietary supplements containing hemp-derived cannabidiol (CBD). This petition addresses industry impatience with the FDA’s efforts to modify the Food, Drug and Cosmetic Act (FDCA), namely its presumption against the lawful marketing of CBD ingredients in dietary supplements arising from the prior clinical research and marketing of CBD as a drug.

CRN’s Citizen Petition specifically requests the FDA to:

  • Issue a regulation allowing CBD to be considered a dietary ingredient despite it being “an article” that was first approved or investigated as a new drug under 21 U.S.C. § 321(ff)(3)(B).
  • Provide guidance clarifying the definition of “an article,” as that term is used to describe substances first used as drugs, which precludes use as a dietary ingredient according to 21 U.S.C. § 321(ff)(3)(B). In the case of CBD, CRN notes the CBD “article” first used as a drug has a different composition than many substances being used or proposed as dietary ingredients. CRN asserts that FDA guidance would encourage New Dietary Ingredient notifications for hemp-derived ingredients that are different from “an article” that is a drug.
  • Enforce existing dietary supplement regulations with respect to CBD-containing products being marketed as dietary supplements.

The CRN petition focuses on CBD use in dietary supplements but does not directly address the regulatory status of CBD as an ingredient for food products. The petition anticipates the FDA establishing a regulatory pathway quickly with potential later action on specific issues, such as use levels and composition. The CRN notes that the lack of FDA action in regulating CBD as a dietary ingredient compromises consumer safety as CBD products enter the market in products labeled as dietary supplements.

In response to previous FDA unwillingness to regulate CBD, the CRN has also requested that Congress declare CBD a lawful dietary ingredient. The FDA has not yet responded to the CRN about its petition. The agency is required to respond to the petitioner within 180 days of receipt of the petition, indicating how it will proceed and if additional time is necessary.

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© 2020 Faegre Drinker Biddle & Reath LLP. All Rights Reserved.National Law Review, Volume X, Number 176
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Michael B. Gastineau Regulatory Attorney Faegre Drinker Biddle & Reath Indianapolis, IN
Associate

Michael helps companies navigate the complex world of FDA-regulated drug and device development and product commercialization. He has experience with the many varied aspects of regulated human subjects research, particularly relating to clinical trial contracting. Michael helps clients negotiate clinical trial agreements, draft pre-clinical trial agreements and HCP consulting agreements. He also advises clients in other health law matters, including purchase and sell agreements and the creation of regulatory compliance and risk plans.

Before joining the firm, Michael was a...

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Kevin P. Boot Product Liability Attorney Faegre Drinker Biddle & Reath Des Moines, IA
Counsel

With nearly two decades of experience, Kevin Boot counsels food, feed and dietary supplement makers on national and international issues and regulations affecting their business. An experienced advisor on food labeling, advertising and marketing compliance, he understands the client’s perspective and needs after spending 15 years in-house in legal and regulatory affairs positions with leading food and feed companies. He collaborates closely with clients to decrease their litigation and enforcement risk while developing and marketing outstanding food products.

Regulatory Compliance...

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Heili Kim Product Safety & Compliance Attorney Faegre Drinker Biddle & Reath Washington, D.C.
Partner

Product safety and compliance are Heili Kim’s priorities. She blends inside knowledge from her role as regulatory counsel for the Food and Drug Administration (FDA) with business pragmatism and international perspective to guide food, dietary supplement, cosmetic and medical device clients on regulatory issues and advertising. She seeks to understand each client’s risk tolerance, objectives and goals to provide client-focused advice that will help the company thrive.

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Heili collaborates with companies whose products are regulated by the FDA to evaluate...

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