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Food Safety

May 22, 2019 | Daily News

FDA expects to propose a number of significant new rules over the next year that will address tobacco product applications, warnings for cigarette packages and advertisements, annual reporting requirements for investigational new drugs, and requirements for drug products that are deemed difficult to compound.

May 17, 2019 | Daily News

FDA issued a draft guidance Friday (May 17) stating the agency will exercise enforcement discretion to allow food manufacturers to use the phrase “potassium chloride salt” on the ingredient statement in food labels as an alternative to the commonly used name of “potassium chloride,” which is used as a partial substitute for sodium chloride to reduce the amount of sodium in prepared and processed foods.

May 10, 2019 | Daily News

In a final guidance document released Thursday (May 9), FDA lays out ways for sponsors of over-the-counter (OTC) topical drugs to conduct in vivo absorption trials that will help the agency determine whether a product is eligible to be included in OTC monograph.

April 30, 2019 | Daily News

FDA announced a slate of new food safety proposals on Tuesday (April 30), including a pilot to use artificial intelligence (AI) and machine learning to review imported foods; an effort to move towards digital food tracing technology; a promise to look into how to oversee the e-commerce food delivery system; and a public meeting to discuss all of the above with industry and state and local governments.

April 25, 2019 | Daily News

Leading consumer advocacy groups say the public health stakes are high in a Freedom of Information Act (FOIA) case heard by the Supreme Court this week, warning in an amicus brief that a decision to tighten restrictions on what information can be released would virtually dry up data the groups have obtained from FDA.

April 25, 2019 | Daily News

FDA issued draft guidance on Tuesday (April 23) that the agency hopes will help all FDA-regulated industries prepare for potential future voluntary recalls and work quickly when they happen.

April 25, 2019 | Daily News

As FDA works to develop an agricultural water rule as a part of its obligations under the Food Safety Modernization Act (FSMA), one consumer advocate said the agency could learn a thing or two from new agricultural water safety standards recently approved by the California Leafy Greens Marketing Agreement (LGMA).

April 18, 2019 | Daily News

The heads of two major dietary supplement lobbies support establishing incentives for the dietary supplement industry, including the possibility of exclusivity, but they are adamant such incentives should not mirror exclusivity as it exists in the prescription drug space.

April 18, 2019 | Daily News

FDA’s food center director Susan Mayne announced the agency will stay the course on its plan to have industry comply with food facility defense regulations beginning in July.

April 16, 2019 | Daily News

Newly minted FDA Acting Commissioner Ned Sharpless said he will not stray far from FDA’s current goals, especially those that were laid out under former commissioner Scott Gottlieb’s leadership.

April 12, 2019 | Daily News

Sources say a memo by the White House Office of Management and Budget that requires federal agencies submit non-binding guidance to the Office of Information and Regulatory Affairs -- and potentially to Congress -- could throw a wrench in FDA’s usual guidance-making process, which could negatively affect both the agency and industry.

April 11, 2019 | Daily News

A food allergy research and patient advocacy group has helped craft a newly introduced bill the group says could foster new therapies by encouraging government agencies such as FDA to collect more data on the patient experience and economic costs of living with food allergies.

April 10, 2019 | Daily News

FDA is taking steps to clarify date labeling on foods and working with the U.S. Department of Agriculture and Environmental Protection Agency to cut down on food waste, the single largest type of waste in Americans’ daily trash, the agency announced Tuesday (April 9).

April 08, 2019 | Daily News

Since his early March announcement that he would be leaving FDA, former agency commissioner Scott Gottlieb ramped up work to wrap up, or initiate, myriad goals he wanted to accomplish during his time with the agency.

April 04, 2019 | Daily News

FDA Commissioner Scott Gottlieb told House lawmakers on Wednesday (April 3) that if the agency doesn't get more resources for its cosmetics safety program it might move cosmetics from the food center to the drug center, since many cosmetics now contain active drug ingredients.

April 03, 2019 | Daily News

Sen. Elizabeth Warren (D-MA) applauded FDA for funding research on durations of use for antibiotics in food animals.

March 21, 2019 | Daily News

Stakeholders representing both industry and consumers called for a re-think of FDA’s generally-recognized-as-safe (GRAS) process, where companies can put a new ingredient in food without agency review.

March 15, 2019 | Daily News

FDA on Friday (March 15) finalized a rule that pushes back deadlines for farms to comply with agricultural water standards required in the Food Safety Modernization Act, despite calls from food safety advocates for the agency to implement interim rules to help prevent future foodborne illness outbreaks, such as the 2018 romaine lettuce E. coli outbreaks.

March 11, 2019 | Daily News

Food industry lawyers say that an agreement penned by FDA and the U.S. Department of Agriculture laying out how the two agencies will regulate cell-based meat and poultry products leaves several key questions unanswered, such as how the review process will work, what standards cell-based meats will have to meet for labeling and what the legal justification is for USDA’s role in regulating the non-traditional meat products

March 11, 2019 | Daily News

FDA experts applauded President Donald Trump’s fiscal 2020 budget request, which includes large increases for FDA, including a net $362 million boost for the agency’s taxpayer-paid budget authority, a $120 million increase for its user fee programs and $161 for new user fee programs.