Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast
Louisiana and Texas recently enacted new legislation imposing disclosure requirements on food and beverage manufacturers, as well as new restrictions on ingredients permitted in public school meals. Some changes take effect...more
The US Food and Drug Administration (FDA) has released its proposed rule on front-of-package (FOP) nutrition labeling. Announced on January 14, 2025, the proposed rule would add a requirement to include an informational box...more
Throughout 2024, the U.S. Food and Drug Administration (FDA) endeavored to curb sales of unauthorized electronic nicotine delivery systems (ENDS) in the U.S. In light of persistent demand for flavored ENDS — nearly all of...more
On December 5, 2024, just in time for the holidays, the U.S. Food and Drug Administration (“FDA” or the “Agency”) released a draft guidance titled “Expedited Program for Serious Conditions: Accelerated Approval of Drugs and...more
On November 21, the FDA sent its proposed rule on front of package (FOP) nutrition labels to the White House Office of Management and Budget (OMB). FOP labeling has been prioritized by the agency as part of a National...more
On March 20, 2024, the US Food & Drug Administration (FDA) issued a proposed rule titled Drug Products or Categories of Drug Products that Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the...more
Although we are only two and a half months in, 2024 has already seen its fair share of impactful 340B developments on both the litigation and legislative fronts....more
Legislators worked late into the night on Thursday to ensure legislation made the Crossover Day deadline. This #GoldDomeReport offers a recap of all the measures that passed out of the House and Senate and live on to seek...more
The U.S. Federal Trade Commission (FTC) took the next step in its long-standing effort to encourage lower prices and increase competition in the pharmaceutical industry. As part of the Biden administration’s whole government...more
We recently reported that several state legislatures are considering bills to establish vapor product directories this year — namely Florida, Indiana, Missouri, and Virginia. Throughout January and early February, similar...more
This year, several state legislatures will consider bills to establish vapor product directories. Amid heightened scrutiny of illicit vapor products by the U.S. Food and Drug Administration (FDA), these product directory...more
The Food and Drug Administration (“FDA”) has released draft interim guidance documents that impact the use of bulk drug substances in compounding under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act...more
Welcome back to The Week in Weed, your Friday look at what’s happening in the world of legalized marijuana. Ohio legislators are busy writing a marijuana law. STATES 2.0 makes an appearance in Congress. The Department of...more
On December 7, 2023, the Biden administration announced a blueprint for a framework that may be a tough pill to swallow for the pharmaceutical industry. This framework suggests that drug prices should be a crucial factor in...more
The U.S. Food and Drug Administration (FDA) issued a long-awaited revised draft guidance on October 23, 2023, which focuses on communications to healthcare providers (HCPs) regarding scientific information on unapproved uses...more
The latest attempt to expand the psychedelic world is making its way through Congress. On September 21, 2023, Congressmen Robert Garcia (CA-42) and Earl Blumenauer (D-OR) introduced the “Validating Independence for State...more
On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the “Guidance”) which adds a piece to the...more
Last month, the FDA’s Office of Cosmetics and Colors issued a Draft Guidance encouraging tattoo ink manufacturers and distributors to recognize situations in which these products may become contaminated with microorganisms,...more
FDA has consistently pursued its aim of encouraging US consumers to eat less salt. As we have previously written, FDA issued a Voluntary Sodium Reduction guidance in October 2021 to support the reduction of average sodium...more
The California Assembly has passed a first-in-the-nation bill banning the use of five food additives, including Red Dye No. 3 and titanium dioxide, in food products manufactured, sold or distributed in the state. The...more
LEGISLATION, REGULATIONS & STANDARDS - FDA Announces Update on Human Foods Program Restructuring - The U.S. Food and Drug Administration (FDA) has issued a news release with an update on the restructuring of its Human Foods...more
The U.S. Food and Drug Administration (FDA) has announced the availability of draft guidance for industry on labeling plant-based milk alternatives. The guidance indicates that plant-based milk alternatives can be labeled as...more
U.S. Food and Drug Administration (FDA) Commissioner Robert M. Califf announced in a Jan. 31 statement that the agency intends to reorganize its Human Foods Program and Office of Regulatory Affairs (ORA) after receiving the...more
Introduction - Let’s say FDA proposed a guidance document that would change the definition of “low cholesterol” for health claims. Now let’s say that when FDA finalized the guidance, instead of addressing that topic, FDA...more
In Short - The Situation: With the calendar officially turned to a new year several significant changes and regulatory initiatives are on the horizon at the Food and Drug Administration ("FDA")....more