On February 11, 2019, Dr. Gottlieb issued a statement that appears to build on statements from December 2018. In December 2018, as part of remarks to the FDLI Enforcement, Litigation, and Compliance Conference, Dr. Gottlieb had alluded to FDA’s plans to step up its efforts …
The question of whether hydroponic operations are eligible for organic certification in the United States has been debated since 1995. In most countries, such as Mexico and Canada, and regions, such as the EU, organic certification cannot be extended to crops not grown in soil. …
Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to present its annual report highlighting the leading cases and settlements from 2018 that affect the FDA- and DEA-regulated industries. Each page provides a concise summary of the relevant facts and key takeaways for our clients. We …
On December 20, 2018, the Agricultural Marketing Service announced the availability of its long-awaited final rule implementing the national mandatory bioengineered (BE) food disclosure standard (NBFDS). The history of the law and rule was discussed in our post on the proposed rule. In the proposed rule, AMS …
As we previously reported, one of the main components of FDA’s 2016 final rule to update the Nutrition Facts is the mandatory requirement for a declaration and a daily value (DV) for “added sugar” for both sugars added to processed foods as well as foods “packaged as …
Once in a while a consumer class action catches our particular attention. Most recently, Kind LLC was sued in the U.S. District Court for the Eastern District of New York over its advertising, labels, and ingredient statements for its “Pressed by KIND” and “KIND Fruit …
Most people think of getting salt water taffy from resort beach town Myrtle Beach, SC. But, apparently, there is more activity going on in Myrtle Beach: a company there was supplying customers with kratom, a substance that the government contends is an illegal dietary supplement. …
Last week FDA published a final guidance and a draft guidance related to the nutrition labeling regulation amendments published in 2016. Final guidance The Guidance, titled “Nutrition and Supplement Facts Labels: Questions and Answers Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of …
As many of our readers know, slack fill litigation has increased within the food and beverage industry over the past several years. Approximately 300 slack fill cases were filed between 2016 and 2017, principally in California and New York. By definition, “slack fill” is the difference …
As we previously speculated might come to pass, FDA announced that it is amending the food additive regulation for synthetic flavoring substances and adjuvants (21 C.F.R. § 172.515) to remove six substances found to induce cancer in animals, namely benzophenone, ethyl acrylate, eugenyl methyl ether …
On September 24, the Information Technology and Innovation Foundation (ITIF) petitioned FDA to prohibit the use of the term “Non-GMO” on consumer foods and goods because according to ITIF the claim is misleading. Although the Petition focuses on the Non-GMO Project Verified “butterfly” logo, it asks …
FDA published a notice requesting information on how consumers use plant-based products whose names include terms such as “milk,” “yogurt,” and “cheese,” and how consumers understand those terms when used in such product names. The notice seeks data and evidence in five major areas, namely: (A) the …
FDA announced the establishment of a new policy that provides for the release of lists of retailers that may have received a food subject to a recall. Historically, FDA has not released such information because it is considered confidential commercial information. FDA now has concluded that …
One of the main components of FDA’s 2016 final rule to update the Nutrition Facts is the mandatory requirement for a declaration and a daily value (DV) for “added sugar” for both sugars added to processed foods as well as foods “packaged as such,” including …
As we previously reported, the most critical issue facing the animal cell cultured industry is a need for clarity on which federal agency – FDA or USDA – will exercise jurisdiction over which aspects of production and distribution. Earlier this year, the discussion heated up …
