A fly in the ointment of novel foods?
Keller Heckman Blogs
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FDA Reopens Comment Period on General Principles for Food Standards Modernization
As previously discussed on this blog, the U.S. Food and Drug Administration (FDA) held a public meeting on September 27, 2019, to give interested parties an opportunity to discuss FDA’s effort to modernize food standards of identity (SOI). On February 20, 2020, FDA announced it plans to reopen the comment period on a 2005 proposed rule (which had initially been jointly published with the U.S. Department of Agriculture (USDA)) to establish a set of general principles…
Several U.S. and State Legislatures Propose Changes to State Bottle Bills and Advocate for a National Bottle Bill
On February 11, 2020, Representative Alan Lowenthal of California and Senator Tom Udall of New Mexico introduced the “Break Free from Plastic Pollution Act of 2020.” The bill would enact nationwide extended producer responsibility for all packaging materials, minimum-recycled-content mandates for certain products, a national container deposit, single-use plastic product bans, a three-year pause on new virgin plastics production facilities, and more. The proposed legislation includes a national bottle bill, which would add…
FDA Releases Third and Final Installment of Intentional Adulteration Draft Guidance
On February 13, the FDA released a supplemental draft guidance to support compliance with the Intentional Adulteration (IA) rule under the Food Safety Modernization Act (FSMA). This draft is the third and last installment of the IA draft guidance.
FSMA’s final IA rule is designed to address hazards that may be intentionally introduced to foods, including by acts of terrorism, with the intent to cause wide-spread harm to the public health. Unlike other FSMA rules…
FDA Releases Draft Guidance on Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe (GRAS) Notices
FDA Releases Draft Guidance on Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe (GRAS) Notices
On February 13, 2020, the Food and Drug Administration (FDA) announced the availability of Draft Guidance for Industry #262, “Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe (GRAS) Notices.” When finalized, the guidance document will help industry submit information for efficient consultations with FDA’s Center for Veterinary Medicine…
Proposed Class Action Lawsuit Claims Arizona Beverage’s Gummies are Not “All Natural” Because They Contain Synthetic Ingredients (Law360 Subscription Required)
On February 11, 2020, Christopher Silva, a New York resident, filed a proposed class action lawsuit against Hornell Brewing Co. Inc., Arizona Beverages USA LLC, Beverage Marketing USA, Inc., and Arizona Beverage Co. (“Defendants”) over defendants’ “all natural” gummy snacks.
The plaintiff claims that defendants’ advertising and marketing campaign is false, deceptive, and misleading because the gummies contain several synthetic ingredients, such as ascorbic acid, citric acid, gelatin, dextrose, glucose syrup, and modified food starch. …
FTC Seeks Comments on Revamping its Endorsement Guides
At a time when influencers are making a living – and sometimes millions of dollars – for promoting everything from eye shadow to the latest smartphone, the Federal Trade Commission (FTC) is reassessing its Guides Concerning the Use of Endorsements and Testimonials in Advertising (the Guides). The Guides provide direction to businesses that use influencers and endorsers on when and how to make disclosures concerning a “material connection” or commercial relationship between the advertiser and…
Trump Administration Proposes to Remove FDA’s Authority to Regulate Tobacco Products
Supplemental New Drug Application Submitted for FDA-Approved CBD Drug Epidiolex
Supplemental New Drug Application Submitted for FDA-Approved CBD Drug Epidiolex
As previously reported in this blog, the 2018 Farm Bill removed hemp – defined as Cannabis sativa L. with less than 0.3% THC on a dry weight basis – from the definition of “marijuana.” As a result, while marijuana remains a Schedule I drug, hemp is no longer a controlled substance under Federal law. However, since CBD has been approved for use in the drug Epidiolex, the Federal Food, Drug, and Cosmetic Act (FD&C…