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Home » FDA

Articles Tagged with ''FDA''

Regulatory Watch

Final guidance issued for added sugars

Sharon Spielman
Sharon Spielman
August 15, 2019
FDA has issued a final guidance to provide clarity on the labeling of added sugars for single-ingredient packages or containers of pure honey, maple syrup and other single ingredient sugars and syrups as a result of a requirement contained in the Agriculture Improvement Act of 2018 (Pub. L. 115-334), known as the Farm Bill.
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Gavel and Chemical Structure of Cannabidiol
CANNABIS PRODUCTS | AUGUST 2019

CBD's shades of gray

While federal regulators have begun to focus in on cannabidiol regulation, much greater clarity is still required.
Doug peckenpaugh
Douglas J. Peckenpaugh
August 5, 2019
The FDA recently held a hearing designed to include information and views related to the safety of cannabis edibles and beverages—with a strong emphasis on cannabidiol (CBD) ingredients—as well as to solicit input relevant to the agency's regulatory strategy for existing products.
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Regulatory Watch

Draft guidance on potassium chloride salt ingredient label

Sharon Spielman
Sharon Spielman
July 17, 2019
FDA intends to exercise this enforcement discretion to provide industry with greater flexibility when labeling food products, including those formulated to reduce sodium content.
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food safety testing
Food Safety

Documentation is key to proving hazard control

Rose Shilling
Rose Shilling
June 19, 2019
Many processors have grown more sophisticated at compiling information and presenting it when inspectors ask for proof that a facility's food safety management system is working. But no matter the companies’ size or record management methods, they likely experience some of the common deficiencies that experts see.
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Regulatory Watch

FDA draft guidance to strengthen voluntary recalls

Sharon Spielman
Sharon Spielman
June 17, 2019
In a new draft guidance, "Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C," there are recommendations in three key areas: training, recordkeeping and procedures.
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marijuana
Manufacturing News

Cannabis: FDA needs your input

Wayne Labs, Senior Contributing Technical Editor
Wayne Labs
June 14, 2019
The FDA held a public hearing on May 31 to solicit oral presentations and comments in order to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling and sale of products containing cannabis or cannabis-derived products.
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Ib Elandaloussi
Food Safety

Is your facility food safe and defensible?

With FSMA a done deal for food & beverage processors, compliance is more important than ever
Wayne Labs, Senior Contributing Technical Editor
Wayne Labs
May 22, 2019

Unless your facility is a USDA shop, then it most likely falls under FSMA regulations, which for the vast majority of processors is the law of the land. If you haven’t yet been visited by FDA for an audit, it is past time to get ready for that inevitable moment. I asked Ib Elandaloussi (CAL), Food and Consumer Products Group with Burns and McDonnell to talk briefly about designing facility solutions to meet FSMA rules.


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food defense

Processors must soon comply with FSMA's rule to try to stop intentional adulteration

Sharon Spielman
Sharon Spielman
May 20, 2019
Under the Intentional Adulteration rule, domestic and foreign food facilities are required to complete and maintain a written food defense plan that assesses their potential vulnerabilities to deliberate contamination where the intent is to cause wide-scale public health harm.
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Regulatory Watch

Shared regulatory approach for livestock, poultry cell-cultured products

May 20, 2019
USDA's FSIS and FDA released a formal agreement to address the regulatory oversight of human food products derived from the cells of livestock and poultry, which describes the oversight roles and responsibilities for both agencies and how they will collaborate to regulate the development and entry of these products into commerce.
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Regulatory Watch

FDA registrations may be lapsed

Sharon Spielman
Sharon Spielman
May 20, 2019
Under FSMA, FDA requires food facilities to renew their FDA registrations between Oct. 1 and Dec. 31 of each even-numbered year.
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