Tag archives: Food Safety

Latest Executive Order shows support for agribusiness development and food safety

By on May 1, 2017 Posted in FDA & Food Safety

On April 25, 2017, President Trump issued the Presidential Executive Order on Promoting Agriculture and Rural Prosperity in America. The Executive Order established the Interagency Task Force on Agriculture and Rural Prosperity that will identify legislative, regulatory, and policy changes to promote in rural American agriculture, such as economic development, job growth, and infrastructure improvement. … Continue reading

Australia: Regulator considers permitting the sale of food derived from low THC hemp seeds

By Bernard O'Shea (AU) and Rohan Sridhar (AU) on August 22, 2016 Posted in FDA & Food Safety

Food Standards Australia New Zealand (FSANZ) is calling for submissions in response to its draft variation of the Food Standards Code that would permit the sale of foods derived from low tetrahydrocannbinol (THC) hemp. The proposal follows a request by the Australia and New Zealand Ministerial Forum on Food Regulation (Forum) for FSANZ to consider … Continue reading

Senate agriculture committee reaches deal on national GMO labeling bill

By on June 24, 2016 Posted in FDA & Food Safety, News from DC

On June 23, 2016, the Senate Agriculture Committee agreed to a bipartisan deal that would set a national standard for GMO labeling. The National Bioengineered Food Disclosure Standard would amend The Agricultural Marketing Act of 1946 by setting forth mandatory disclosure requirements for GMO food products, while providing a variety of options to the industry … Continue reading

U.S. Food and Drug Administration announces new partnership with Canadian Food Inspection Agency on food safety

By Sara Zborovski (CA) and Jillian Hyslop (CA) on June 13, 2016 Posted in FDA & Food Safety

Summary On May 4, 2016, the U.S. Food and Drug Administration (FDA) signed a “systems recognition arrangement” with the Canadian Food Inspection Agency (CFIA) and Health Canada recognizing the comparability of the U.S. and Canadian food safety systems. This is only the second time that the FDA has recognized a foreign food safety system as … Continue reading

FDA issues final FSMA implementing rule

By on May 31, 2016 Posted in FDA & Food Safety

The 7th and final Food Safety Modernization Act (FSMA) implementing rule is finally here and most companies will have three years to comply. On May 26, 2016, the FDA finalized the Mitigation Strategies to Protect Food Against Intentional Adulteration rule. The effective date of the rule is May 27, 2016, the date of the rule’s … Continue reading

FDA approves first implantable buprenorphine maintenance treatment for opioid addiction

By Yvonne Puig (US) and Mark Faccenda (US) on May 27, 2016 Posted in Regulatory

On May 26, 2016, the Food and Drug Administration (FDA) approved Probuphine as part of a targeted initiative by the U.S. Department of Health and Human Services (HHS) and the FDA to reduce prescription opioid and heroin-related overdose, death and dependence.… Continue reading

FDA finally unveils new nutrition facts label

By on May 25, 2016 Posted in FDA & Food Safety

Added Sugars are in. Calories From Fat are out. And would the typical American eat the package of food in one sitting? If so, those Americans will now know from the label what they will consume in that sitting.… Continue reading

TPP and biologics – a battleground in Australian elections

By Bernard O'Shea (AU) and Rohan Sridhar (AU) on May 10, 2016 Posted in FDA & Food Safety

The Australian Labor Party has flagged the data exclusivity provisions of the Trans Pacific Partnership Agreement (TPP) as a major issue ahead of our now confirmed July date for an Australian election.… Continue reading

FDA issues final menu labeling guidance

By on May 10, 2016 Posted in FDA & Food Safety

On April 29, 2016, the US Food and Drug Administration (“FDA”) issued the final guidance on menu labeling titled “A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods – Part II.”… Continue reading

Times, they are a-changin’ – new country of origin food labeling system effective 1 July 2016

By Frances Drummond (AU) and Alyson Poole (AU) on May 6, 2016 Posted in FDA & Food Safety

Summary From 1 July 2016, new country of origin labeling requirements will become a reality in Australia, with a new food labeling system commencing under the Australian Consumer Law. The implementation of the new system will have a two year transition period. From 1 July 2018, the new system will be mandatory and something which … Continue reading

FDA warns of potential link between antimalware and medical device failure

By Mark Faccenda (US) on May 6, 2016 Posted in FDA & Food Safety

On February 8, 2016, the U.S. Food and Drug Administration (FDA) issued a Product Problem Report concerning the following device: Merge Hemo Programmable Diagnostic Computer, manufactured by Merge Healthcare. The Merge Hemo device monitors, measures and records physiological data from patients undergoing cardiac catheterization procedures and transfers this data to a monitoring station that runs … Continue reading

Australia – States and territories agree to country of origin food labelling reforms

By on April 20, 2016 Posted in FDA & Food Safety

Australia’s country of origin labelling system for food products is to be overhauled following agreement by State and Territory Ministers for Consumer Affairs. Food offered for retail sale in Australia will be required to be labelled more clearly to inform consumers of the product’s origins.… Continue reading

Australia: Victoria creates new medical cannabis regime – children with epilepsy first to have access

By on April 20, 2016 Posted in FDA & Food Safety

The use of cannabis for restricted medical purposes is set to be legalised in Victoria following the passing of the Access to Medicinal Cannabis Bill 2015. The Bill creates a new legal regime that regulates the cultivation, manufacture and supply of cannabis in Victoria, and allows for specified categories of patients to have access to … Continue reading

FDA establishes bright-line recommendations for human drug compounding

By Yvonne Puig (US) and Mark Faccenda (US) on April 19, 2016 Posted in FDA & Food Safety

On April 15, 2016, the U.S. Food and Drug Administration (FDA) released three draft guidance documents addressing human drug compounding under the Federal Food Drug, and Cosmetic Act (FDCA). FDA issued new policies concerning the prescription requirement under section 503A of the FDCA, human drug compounding in hospitals and health systems, and the facility definition … Continue reading

FDA issues final rule for sanitary food transport, giving companies 1 year to comply

By on April 13, 2016 Posted in FDA & Food Safety

On April 6, 2016, the Food and Drug Administration (FDA) published the final rule for the sanitary transportation of human and animal food. The rule aims to prevent food contamination during transportation by requiring covered entities involved in transporting human and animal food to follow recognized best practices for sanitary transportation. The rule seeks to … Continue reading

Australian TGA on cyber security

By Bernard O'Shea (AU) on April 4, 2016 Posted in FDA & Food Safety

In a timely note, the March 2016 edition of the Medical Devices Safety Update, put out by the Australian Therapeutic Goods Administration, highlights medical device cyber security as a key issue. Interestingly, this comes shortly after the release by the FDA of its draft guidance in relation to “Post Market Management of Cyber Security in … Continue reading

FDA requires new “black-box” safety warnings for opioid drugs

By Yvonne Puig (US) and Mark Faccenda (US) on March 22, 2016 Posted in FDA & Food Safety

On March 22, 2016, the US Food and Drug Administration (FDA) issued a safety announcement that includes required labeling changes for immediate-release (IR) opioid pain medication (and the entire class of opioid drugs) and recommendations and information for patients and health care professionals. The FDA’s new safety warnings and required labeling changes come shortly after … Continue reading

Senate blocks anti-GMO labeling bill

By on March 22, 2016 Posted in FDA & Food Safety, News from DC

On March 16, 2016, the U.S. Senate voted 48-49 against invoking cloture to cut off a filibuster on the Biotechnology Labeling Solutions Act. The bill would have established a federal standard of voluntary labeling and preempted any mandatory GMO labeling state laws. In July 2015, a similar bill called the Safe and Accurate Food Labeling … Continue reading

Amarin and FDA settle off-label suit

By Robert Rouder (US), Katharyn Grant (US) and Saul Perloff (US) on March 9, 2016 Posted in FDA & Food Safety

As we reported last August, U.S. District Judge Paul Engelmayer ruled that Amarin Pharma has a First Amendment right to truthfully promote its prescription drug Vascepa for off-label uses. August 10, 2015, article. Shortly afterward, Amarin and the government entered settlement talks. August 31, 2015 update. We are now able to report that on March … Continue reading

FDA issues guidance on screening blood and tissue donors for the Zika Virus

By Yvonne Puig (US) and Mark Faccenda (US) on March 3, 2016 Posted in FDA & Food Safety

On March 1, 2016, the U.S. Food and Drug Administration (FDA) issued guidance on screening donors of human cells, tissues, and cellular and tissue-based products for risk of evidence of infection with Zika virus. The FDA’s guidance identifies Zika virus as a relevant communicable disease agent or disease (RCDAD) and provides recommendations for reducing the … Continue reading

The debate over the appropriate use of ‘natural’ in food labelling continues…

By Georgina Hey (AU) on February 17, 2016 Posted in FDA & Food Safety

Food labelling has long been a vexed question in many countries for governments, consumers, food producers and retailers alike. In Australia, the regulation of food labelling was substantially overhauled by the Food Standards Australia New Zealand (FSANZ) Code in 2013, with the 3 year phase in period for these changes recently ending. The difficulty that … Continue reading

The use of medical cannabis in Australia: New Victorian synthetic cannabinoids regulations commence

By Rohan Sridhar (AU) on January 5, 2016 Posted in FDA & Food Safety

The Victorian Government has introduced new regulations, prescribing various forms of synthetic cannabis as drugs of dependence for the purposes of the Drugs, Poisons and Controlled Substances Act. … Continue reading

Updates to low THC hemp food in Australia

By Rohan Sridhar (AU) on January 5, 2016 Posted in FDA & Food Safety

As previously noted, low tetrahydrocannabinol (THC) hemp for human consumption in Australia has been mooted as a potential basis of inexpensive food and expanded sales capability for farmers who currently grow hemp for industrial purposes. This has been particularly sought after in Tasmania where the majority of industrial hemp is currently grown.… Continue reading

Commonwealth issues new imported food controls

By Rohan Sridhar (AU) on November 24, 2015 Posted in FDA & Food Safety

Australian Agriculture Minister, Barnaby Joyce, has introduced new orders designed to complete the Government’s changes to the Imported Food Control Regulations (Regulations) in respect of recognised foreign government certification. In March 2015, the Government amended the Regulations to allow the Minister to make orders requiring certain “risk foods” to be inspected and/or analysed under the … Continue reading