The long-awaited final rule by the Food and Drug Administration (FDA) on gluten-free labeling was published in the Federal Register on Aug. 5. This voluntary rule became effective on Sept. 4, with the compliance date set for Aug. 5, 2014. 

Federal officials have updated the number of patients in an outbreak of E. coli O157:H7 infections traced to slivered onions on McDonald’s Quarter Pounder hamburgers. The patient count now stands at 104. The Food and Drug Administration and the Centers for Disease Control and Prevention are continuing to investigate the... Continue Reading

The Sandiganbayan has acquitted former Food and Drug Administration chief Nela Charade Puno of graft, which stemmed from a raid and closure by the FDA of a pharmacy and wellness center in Tarlac.

<p>On 10 October 2024, the US Food and Drug Administration (FDA) approved Accord’s Imuldosa (ustekinumab-srlf), making it the fifth ustekinumab biosimilar referencing Janssen/Johnson &amp; Johnson’s Stelara.</p>

Aachen, Germany, 22 May 2023 – Grünenthal today announced that its investigational non-opioid medicine resiniferatoxin (RTX), currently undergoing clinical Phase III development, received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for pain associated with osteoarthritis (OA) of the knee. The decision is based on clinical phase I and II data indicating significant pain relief and a favourable safety profile.

- FDA approved blinded, multi-centric Phase-3 trial (NCT06489028) to investigate the safety and efficacy of allo-APZ2-CVU in patients with CVU

Michael Hiltzik, Los Angeles Times, on the fall of the US Food and Drug Administration from the old days of real oversight to modern times of rubber-stamping:

"Is the motto of the Food and Drug Administration "safety last" when it comes to the Lap-Band?" --
http://latimesblogs.latimes.com/money_co/2011/02/michael-hiltzik-the-fda-and-the-lap-band.html

In what has been a long period of relative low activity, FDA’s OPDP has taken the opportunity to remind us that low enforcement does not mean no enforcement when it comes to promotional speech by pharmaceutical companies. This past June … Continue reading →

For the second time this month and the third time this year, FDA’s OPDP has posted notice that it has taken an enforcement action. Last week, a Warning Letter was posted regarding a sales aid. This week it action came … Continue reading →

Having passed the mid-year point, it is always an interesting exercise to take stock of where we stand with respect to the approval of new medicines. Overall, when considering the volume of activity, things would seem to be looking up … Continue reading →

FDA announced this week the formation of a new advisory committee – the Digital Health Advisory Committee – for the purpose of providing the agency with advice on matters related to digital health technologies (DHT). FDA does not form new … Continue reading →

While enforcement has been at a low ebb for quite some time with FDA’s Office of Prescription Drug Promotion (OPDP), this week took a different turn with the posting of two new untitled letters sent October 31. That brings the … Continue reading →

Last week FDA’s Office of Prescription Drug Promotion issued its first regulatory action letter of the year. This was an Untitled Letter – a/k/a Notice of Violation Letter (NOV) – sent by the agency to Novartis in relation to promotional … Continue reading →

Less is more? Every so often is it worthwhile to look back at FDA to see what they had to say in a given year, and in addition, how they said it. One might not think that a large agency … Continue reading →

Back in December 2023, FDA announced intention in the Federal Register and in a press release to form a new FDA Advisory Committee to be called the Genetic Metabolic Diseases Advisory Committee (GeMDAC). As noted in a recent posting here, … Continue reading →

The Food and Drug Administration could put a stop to the use of phenylephrine, an ingredient in over-the-counter nasal decongestants, because its studies found it doesn't work.

A top U.S. commercial bakery is pushing back on a Food and Drug Administration warning to stop using labels that say its products contain sesame — even when they don't

The post Bakery that makes Sara Lee and Entenmann’s pushes back on FDA sesame warning appeared first on Boston.com.

Washington — Two environmental groups, along with 75 salon workers from across the country, have filed a citizen petition asking the Food and Drug Administration to ban hair straighteners containing formaldehyde.

Washington — Manufacturers of certain N95 respirators will be able to submit a single application to NIOSH, rather than to both the Food and Drug Administration and NIOSH, before marketing their product to the health care industry, according to an FDA final order published in the May 17 Federal Register.

Washington — Prompted by an “increased domestic supply” of NIOSH-approved respirators, the Food and Drug Administration is recommending health care facilities transition away from strategies intended to conserve supplies of disposable respirators amid the COVID-19 pandemic.

Washington — Prompted by an “increased domestic supply” of NIOSH-approved respirators, the Food and Drug Administration has revoked its emergency use authorizations for non-NIOSH-approved disposable respirators as well as decontamination and bioburden reduction systems.

Washington — OSHA, the Centers for Disease Control and Prevention, and the Food and Drug Administration have released joint interim guidance intended to help seafood processing employers reduce COVID-19 exposure among workers, including those at onshore facilities and aboard offshore vessels.

Washington — OSHA and the Food and Drug Administration have teamed up to develop a checklist intended to help food manufacturers protect worker health and practice food safety during the COVID-19 pandemic.

Washington — The approval of a second over-the-counter naloxone nasal spray for emergency treatment of a known or suspected opioid overdose is a “game-changer” for its lifesaving potential, the National Safety Council says.

Taking prescription medicines known as “Z-drugs” for insomnia may lead to complex sleep behaviors, overdose, injury and – in rare cases – death, the Food and Drug Administration cautions in a recent alert.

The US Food and Drug Administration proposed to revoke the regulation authorizing the use of brominated vegetable oil (BVO) in food. The agency concluded that the intended use of BVO in food is no longer considered safe after the results of studies conducted in collaboration with the National Institutes of Health (NIH) found the potential for adverse health effects in humans.

Chapter 11—Food Allergen Program—explains how to establish and implement a food allergen program that ensures protection of food from major food allergen cross-contact and that the finished food is properly labeled with respect to the major food allergens.

The US Food and Drug Administration announced that it intends to propose that “Acacia (Gum Arabic)” also known as gum acacia, be included as part of the FDA's definition of dietary fiber. The action is being taken in response to a citizen petition from Nexira, Alland & Robert and Importers Service Corporation.

High oleic soybean oil oleic acid levels exceed 70% and can go as high as 75%, and the oil is lower in saturated fat compared to some other high-stability oils commonly used in food production.

If 2020 was the year of supply chain uncertainty due to COVID-19, 2021 may well be the year that transparency in food labeling takes center stage, particularly for gluten-free products.

The US Food and Drug Administration launched an initiative to help consumers use the new Nutrition Facts label that appears on packaged foods to maintain healthy dietary practices.

GMO is a common term used by consumers to describe foods that have been created through genetic engineering. While GMOs have been available to consumers since the early 1990s and are a common part of today's food supply, research shows consumers have limited knowledge and understanding about what GMOs are, why they are used, and how they are made.

More than 80% of people in the US aren’t eating enough vegetables, fruit and dairy. And most people consume too much added sugars, saturated fat and sodium. The proposed rule is part of the agency’s ongoing commitment to helping consumers improve nutrition and dietary patterns to help reduce the burden of chronic disease and advance health equity. 

Earlier this year, US Food and Drug Administration Commissioner Robert M. Califf, M.D. laid out a bold vision to transform the agency's human foods enterprise. I am thrilled to have joined the FDA last month as the first Deputy Commissioner for Human Foods to help make this vision a reality.

FDA has initiated an onsite inspection at the Austrofoods facility located in Ecuador.

FDA advises restaurants and retailers not to serve or sell and consumers not to eat chopped clams illegally harvested in Massachusetts and distributed by Red’s Best.

This new requirement was established following a months-long infant formula shortage sparked by insanitary conditions at one of the nation’s largest infant formula facilities. 

D-tagatose must be declared as an added sugar on the Nutrition Facts label, but it contains fewer calories than sucrose or table sugar.

The updated list includes select food ingredients (including food and color additives), food contact substances and contaminants under FDA review.

The request includes an increase of $495 million—or 7.4 percent above the FY 2023 funding level.

The U.S. Food and Drug Administration (FDA) has released a revised draft Introduction and Appendix 1 to the multi-chapter draft guidance for industry titled “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry” (PCHF Draft Guidance).

The alert gives the FDA the ability to help prevent entry of human food products into the U.S. if they are found to be contaminated with a broad range of human-made chemicals.

The meeting is designed to help the agency improve its understanding of how it can leverage data and technology to exponentially advance food safety and achieve better health outcomes.

The FDA says revoking the standards will provide greater flexibility and the opportunity for product innovation.

The guidance describes how firms can voluntarily engage with the FDA before marketing food from genome-edited plants.

An evaluation reveals that there isn’t enough data on the use of tara flour in food, or a history of its safe use, to consider it GRAS.

 In the final rule, the FDA announced its intention to consider exempting cottage cheese regulated under the Grade “A” Pasteurized Milk Ordinance (PMO) from the rule’s requirements.

The sampling was conducted to better understand the extent to which these products potentially contain unintended milk at levels that may be hazardous to people with milk allergy.