As we discussed previously, FDA’s 2016 final regulation updating nutrition labeling requirements included a requirement to declare added sugars. This requirement created quite a stir among several segments of the industry. Among others, the honey and maple syrup manufacturers pushed back on the requirement to …
We knew it would be back. It was never dead, though perhaps forgotten by some (never us), but OTC Monograph Reform is back in the public eye again. Lawmakers appear to be taking to heart CDER Director Janet Woodcock’s remarks last week in which she urged …
In a 6-3 decision, the U.S. Supreme Court reversed and remanded the lower courts’ decision to publicly disclose commercial information that previously had been submitted to the government. Given that FDA-regulated entities often submit to FDA commercial or financial information that those entities regard as …
FDA recently announced new changes it is making to the Medical Device Reporting (MDR) program as part of its ongoing efforts to increase transparency on device performance, and detection of device-related safety concerns. FDA is formally discontinuing the Alternative Summary Reporting (ASR) Program, which permitted certain …
The authors of this blog are busy, and we are actively seeking attorneys interested in working at the nation’s largest boutique food and drug regulatory law firm (and ideally writing for the FDA Law Blog). We have at least two openings: The first position is for …
FDA published a Consumer Update acknowledging the ubiquitous presence of CBD products in the marketplace, and providing the agency’s current perspective on questions regarding the regulatory status, safety, and quality of such products. The Consumer Update follows closely on the heels of a recent statement issued jointly …
The pharmaceutical industry has filed a lawsuit challenging a recently finalized rule from the Centers for Medicare & Medicaid Services (CMS) which requires drug pricing disclosures in television advertisements for certain prescription drugs and biological products (the Final Rule). In an effort to block the …
The government lost a significant battle in its aggressive prosecutions of individuals involved in the New England Compounding Center (NECC) disaster, in which the vilified, and now-defunct, NECC “compounded” contaminated batches of drugs that led to a multitude of deaths and injuries. Gregory Conigliaro, a …
The Paragraph IV certification list on FDA’s website is a very useful tool for generic drug manufacturers in evaluating the potential for 180 day exclusivity for any given product. The list generally describes drug products for which one or more substantially complete ANDA containing a paragraph …
On June 5, 2019, the Animal Plant Health Inspection Service of the USDA (APHIS) announced the availability of a proposed rule titled “Movement of Certain Genetically Engineered Organisms.” The proposed rule was published on June 6, 2019. On June 7, the 449 pages long draft environmental …
On June 3, 2019, the Agricultural Marketing Service (AMS) announcedthat the National Organic Program (NOP) published a letter to certifiers titled, “Certification of Organic Crop Container Systems.” Over the last decade, there has been a disagreement within the organic industry about use of container systems in …
The U.S. Food and Drug Administration (FDA) recently issued a guidance document that intends to “help small businesses better understand and comply” with the Agency’s Section 503A bulk substances final rule, issued February 19, 2019. The final rule establishes FDA’s criteria for evaluating nominated bulk …
In recent years, food waste has received increasing attention. Based on studies, it appears that up to 40 percent of the food in the United States is never eaten. Waste occurs at every step in the food production and consumption chain. However, data suggest that …
The American Conference Institute (“ACI”), together with the Council for Responsible Nutrition, are sponsoring ACI’s Annual Legal, Regulatory, and Compliance Forum on Dietary Supplements. The conference is scheduled to take place at the InterContinental New York Times Square in New York, New York from June …
Hyman, Phelps & McNamara, P.C., the nation’s largest boutique food and drug regulatory law firm, seeks a junior to mid-level associate. A demonstrated interest in food and drug law and regulation is preferred; strong research and writing skills are required. Compensation is competitive and commensurate …
