In November 2013, the Food Safety Inspection Service (FSIS) of the USDA issued a regulation expanding the circumstances in which labels were eligible for generic label approval (see our previous post here). Under that regulation, meat and poultry labels need not be submitted for label …
In June 2017, two consumer advocacy organizations, the Center for Science in the Public Interest and the National Consumer League (“Plaintiffs”), sued FDA challenging the Agency’s interim final rule extending the compliance date for menu labeling and request for comments (see our previous post here). …
On August 3, 2017, FDA announced the availability of a draft guidance regarding child resistant packaging statements on drug products labels and labeling. To be clear, this draft guidance addresses the inclusion of a voluntary statement in the labeling for drug products, prescription as well …
Natural claims remain fodder for litigation. Although FDA’s December 2015 request for comments certainly impacted the filing of lawsuits (as discussed in our previous post), new cases continue to be filed, and plaintiffs bring up new arguments against natural claims. One relatively recent trend sees plaintiffs …
As we reported a couple of months ago, the naming of plant-based products continues to be an issue. For at least two decades, there has been uncertainty as to the use of the term “milk” and other dairy terms for products derived from plant material …
As readers of this blog know, in May 2016, FDA issued a final rule amending the nutrition labeling regulations for food and dietary supplements. Major amendments include a new requirement to declare “added sugar,” the setting of a daily value for added sugars (but not …
As we previously reported, FDA recently extended the compliance date for its restaurant menu labeling regulations to May 8, 2018. Just one day before the previous (May 5, 2017) compliance date, FDA published an interim final rule (IFR) that delayed compliance for one year and …
On June 13th, FDA’s Office of Nutrition and Food Labeling “announced” that it intends to extend the compliance date for the new Nutrition Facts requirements. As we previously reported, FDA received several citizen petitions requesting an extension of the compliance date. In addition, some in …
As readers of this blog know, natural claims have been and continue to be a frequent basis for consumer class actions. Initially, lawsuits appeared to focus on natural claims for foods (and dietary supplements). However, natural claims for personal care products also have become a …
On April 10, 2017, the American Bakers Association (ABA) submitted a Citizen Petition and a Petition for Stay of Action on FDA’s new definition of dietary fiber in 21 C.F.R. § 101.9(c)(6)(i), and the accompanying recordkeeping requirement in 21 C.F.R. § 101.9(g)(10) and (11). By way …
Antibiotic-resistant bacteria are claimed to be one of the biggest threats to global health, sickening an estimated 2 million people in the United States each year. There is evidence that some resistance in bacteria is caused by antibiotic use in food animals (cattle, poultry, swine). …
With the expanding market for plant-based foods, often developed as an alternative to the animal-based food products which consumers avoid for various reasons (allergies, health concerns, ethical concerns, environmental concerns, or taste preference), the naming of plant-based foods has become a major issue. Although the issue …
On February 15, FDA announced a public meeting to give interested persons an opportunity to discuss the use of the term “healthy” in the labeling of human food. As described in previous blog posts, since FDA’s issuance of a warning letter to Kind LLC in March of …
Last month we reported that the Hemp Industries Association (“HIA”) petitioned the U.S. Court of Appeals for the Ninth Circuit to block the Drug Enforcement Administration’s (“DEA’s”) implementation of its recent final rule on marijuana extracts. On February 6, 2017, HIA filed another action with …
As previously reported, on May 1, 2015, FDA issued a proposal to amend the 1994 Tentative Final Monograph (TFM) for the over-the counter (OTC) health care antiseptic drug products, including health care personnel hand washes, health care personnel hand rubs, surgical hand scrubs, surgical hand …
