Food and Drug Administration Archives

NFI Statement on FDA/USDA Food Safety MOU

May 20, 2020 — The following was released by the National Fisheries Institute:

The National Fisheries Institute is pleased to see the Food and Drug Administration (FDA) and the Agriculture Department (USDA) working together to ensure continued food safety during the COVID19 pandemic.

Recognizing that the FDA draws its jurisdiction from the Federal Food, Drug, and Cosmetic Act and the USDA regulates via the Federal Meat Inspection Act, it is more important than ever to have these vital agencies communicating and collaborating. While seafood remains available at grocers and restaurants, we thank the Administration for planning ahead.

NFI members are taking the needed steps to keep our essential workers safe and continuing to provide consumers with healthy seafood. This memorandum of understanding will benefit frontline food safety and help avoid interruptions that might unnecessarily disrupt seafood production.

Seafood restaurants start “National Takeout Day” to boost sales during pandemic

March 24, 2020 — A coalition of restaurants across the United States is urging consumers to sustain the foodservice industry during the COVID-19 pandemic by taking part in “The Great American Takeout” on Tuesday, 24 March.

Separately, many seafood restaurants have also taken to social media with innovative campaigns and efforts designed to encourage Americans to order take-bout or delivery from them.

Read the full story at Seafood Source

Food Safety and the Coronavirus Disease 2019 (COVID-19)

March 18, 2020 — The following was released by the Food and Drug Administration:

Q: Is the U.S. food supply safe?

Currently there is no evidence of food or food packaging being associated with transmission of COVID-19.

Unlike foodborne gastrointestinal (GI) viruses like norovirus and hepatitis A that often make people ill through contaminated food, SARS-CoV-2, which causes COVID-19, is a virus that causes respiratory illness. Foodborne exposure to this virus is not known to be a route of transmission.

The virus is thought to spread mainly from person-to-person. This includes between people who are in close contact with one another (within about 6 feet), and through respiratory droplets produced when an infected person coughs or sneezes. These droplets can land in the mouths or noses of people who are nearby or possibly be inhaled into the lungs. It may be possible that a person can get COVID-19 by touching a surface or object that has the virus on it and then touching their mouth, nose, or possibly their eyes, but this is not thought to be the main way the virus spreads. However, it’s always critical to follow the 4 key steps of food safety—clean, separate, cook, and chill – to prevent foodborne illness.

Q: Will there be food shortages?

There are no nationwide shortages of food, although in some cases the inventory of certain foods at your grocery store might be temporarily low before stores can restock. Food production and manufacturing are widely dispersed throughout the United States and no widespread disruptions have been reported in the supply chain.

FDA is closely monitoring the food supply chain for any shortages in collaboration with industry and our federal and state partners. We are in regular contact with food manufacturers and grocery stores.

Q: Where should the food industry go for guidance about business operations?

Food facilities, like other work establishments, need to follow protocols set by local and state health departments, which may vary depending on the amount of community spread of COVID-19 in a particular area. We encourage coordination with local health officials for all businesses so that timely and accurate information can guide appropriate responses in each location where they have operations.

Q: A worker in my food processing facility/farm has tested positive for COVID-19. What steps do I need to take to ensure that the foods I produce are safe?

Coronaviruses are generally thought to be spread from person-to-person through respiratory droplets. Currently, there is no evidence to support transmission of COVID-19 by food. Unlike foodborne gastrointestinal (GI) viruses like norovirus and hepatitis A that often make people ill through contaminated food, SARS-CoV-2, which causes COVID-19, is a virus that causes respiratory illness. Foodborne exposure to this virus is not known to be a route of transmission.

If an employee is confirmed to have COVID-19, employers should inform fellow employees of their possible exposure to COVID-19 in the workplace but maintain confidentiality. Sick employees should follow the CDC’s What to do if you are sick with coronavirus disease 2019 (COVID-19). Employers should consult with the local health department for additional guidance.

While the primary responsibility in this instance is to take appropriate actions to protect other workers and people who might have come in contact with the ill employee, facilities should re-double their cleaning and sanitation efforts to control any risks that might be associated with workers who are ill regardless of the type of virus or bacteria. For example, facilities are required to maintain clean and sanitized facilities and food contact surfaces.

See: FSMA Final Rule for Preventive Controls for Human Food.

Food facilities are required to use EPA-registered “sanitizer” products in their cleaning and sanitizing practices.
In addition, there is a list of EPA-registered “disinfectant” products for COVID-19 on the Disinfectants for Use Against SARS-CoV-2 list that have qualified under EPA’s emerging viral pathogen program for use against SARS-CoV-2, the coronavirus that causes COVID-19.
IMPORTANT: Check the product label guidelines for if and where these disinfectant products are safe and recommended for use in food manufacturing areas or food establishments.

Q: Do I need to recall food products produced in the facility during the time that the worker was potentially shedding virus while working?

We do not anticipate that food products would need to be recalled or be withdrawn from the market because of COVID-19, as there is currently no evidence to support the transmission of COVID-19 associated with food or food packaging.

Additionally, facilities are required to control any risks that might be associated with workers who are ill regardless of the type of virus or bacteria. For example, facilities are required to maintain clean and sanitized facilities and food contact surfaces.

Q: If a worker in my food processing facility/farm has tested positive for COVID-19, Should I close the facility? If so, for how long?

Food facilities need to follow protocols set by local and state health departments, which may vary depending on the amount of community spread of COVID-19 in a given area. These decisions will be based on public health risk of person-to-person transmission – not based on food safety.

Everything You Need To Know About The Coronavirus And Seafood Safety

March 16, 2020 — The coronavirus (COVID-19) outbreak is affecting industries worldwide, and seafood is no exception. With high anxiety and fear surrounding the virus, misinformation can spread quickly as everyone tries to make sense of a rapid change of lifestyle. Here’s what you need to know about how the coronavirus affects seafood safety, according to public health professionals.

There is no evidence suggesting that the coronavirus can be spread through food products or food packaging

As of now, there’s no evidence of COVID-19 transmission through food. According to the FDA regarding the safety of consumer products: “Again, we want to reassure the public that at this time there is no evidence that food or food packaging have been associated with transmission and no reason to be concerned”.

The source of the virus is still unknown

According to the World Health Organization, there have been no confirmed animal sources of COVID-19. According to the most recent situation report from March 14th, the virus does have a live animal source, but that source is unknown at this time. However the WHO does offer the following advice as a precaution: “when visiting live animal markets, avoid direct contact with animals and surfaces in contact with animals” They advise to use good food safety practices at all times and to “handle raw meat, milk or animal organs with care to avoid contamination of uncooked foods and avoid consuming raw or undercooked animal products”. These precautions do not differ from normal food safety precautions.

Additionally, the WHO states that receiving packages from an area where COVID-19 has been reported is safe: “The likelihood of an infected person contaminating commercial goods is low and the risk of catching the virus that causes COVID-19 from a package that has been moved, travelled, and exposed to different conditions and temperature is also low”.

Read the full story at Forbes

Fishermen’s group declares “partial victory” after court ruling on GM salmon

January 3, 2020 — Even though a federal judge ruled in December that the U.S. Food and Drug Administration has the authority to regulate genetically modified salmon, a commercial fishing group that sued the agency is declaring “partial victory.”

That’s because, in May, the judge will hear arguments on the second part of the case, which questions whether the FDA’s approval of GM salmon was deficient.

Read the full story at Seafood Source

‘Frankenfish’ Salmon Can Be Overseen by FDA Despite Concerns

December 23, 2019 — The Food and Drug Administration can regulate salmon that’s genetically engineered to grow faster, according to a decision in a California federal court case over concerns about so-called frankenfish.

Fishing, consumer, and environmental groups that challenged the FDA’s approval of such salmon from AquaBounty Technologies Inc. failed to convince the court that the agency lacks authority to regulate the fish. The U.S. District Court for the Northern District of California Dec. 19 sided with the FDA, leaving to a later date a decision on whether the regulator failed to consider potential risks.

AquaBounty won the FDA’s first greenlight for changing the genetic makeup of an animal destined for the dinner table. The case could have implications for similar modifications in the works for fish like tilapia and trout or other animals down the line, according to the Center for Food Safety, one of the groups that sued.

“That’s why we were so concerned about this approval,” said Amy van Saun, a senior attorney at the center. “We want to make sure people and the environment are protected.”

Genetically engineered salmon are meant as an alternative to endangered wild salmon. AquaBounty plans to harvest its salmon starting in late 2020.

Read the full story at Bloomberg Law

Everybody knows to avoid tuna when pregnant, right? Not so fast. Eating tuna might actually yield better results, says a large new study.

November 26, 2019 — Eating ocean fish is good for you, but some fish have significant levels of methylmercury which is bad for you, so you should avoid those fish, right? Wrong, says a new study.

Mothers who ate seafood, even when it contained high levels of methyl mercury, had smarter kids than those who didnʻt eat seafood, says the comprehensive, peer-reviewed study.

“Moderate and consistent evidence indicates that consumption of a wide range of amounts and types of commercially available seafood during pregnancy is associated with improved neurocognitive development of offspring as compared to eating no seafood,” it said.

This flies in the face of conventional wisdom, and some medical wisdom. Both the U.S. Environmental Protection Agency and the U.S. Food and Drug Administration recommend against pregnant women eating ahi, over concerns about methyl mercury exposure.

There is no question that thereʻs methylmercury in yellowfin, bigeye and bluefin tuna, and that the amount has been increasing in recent years. There are also significant amounts of mercury in blue marlin and other species.

The Hawai`i Department of Health warns against pregnant women eating any blue marlin, swordfish and shark and recommends severe limits on consumption of tunas.

Read the full story at Raising Islands

FDA panel endorses wider use of fish-oil drug to protect against heart problems

November 15, 2019 — A panel of experts unanimously recommended Thursday that the Food and Drug Administration allow wider use of a fish oil-based drug to treat people at high risk for heart attacks and strokes even when they are taking cholesterol-lowering drugs.

The 16-0 endorsement of the FDA advisory committee puts Dublin-based Amarin Corp. one step closer to widespread distribution of Vascepa, a drug the company has said could be worth billions of dollars annually. The FDA, which usually follows such guidance, could make a long-awaited final decision next month.

“There’s a definite need for additional therapeutic approaches,” said Kenneth D. Burman, chief of the endocrine section at MedStar Washington Hospital Center, who chaired the panel. Despite some side effects, he said, “this seems a very useful new agent for addition to the armamentarium for the treatment of these patients.”

The drug, a purified version of the Omega-3 fatty acid found in fish, is aimed at some of the more than 40 million people in the U.S. who take statins to control their LDL, or “bad” cholesterol, and have adopted lifestyle changes, yet remain at risk of cardiovascular problems because of elevated triglyceride levels.

Triglycerides are another type of fat in the blood. When their levels are too high, generally more than 200 milligrams per deciliter of blood, the result can be deaths, heart attacks, strokes, unstable angina or the need for cardiac surgery.

A landmark 2018 study, led by a researcher at Brigham and Women’s Hospital and sponsored by Amarin, showed that patients who took four grams of Vascepa daily fared 25 percent better in staving off those events than those given a placebo. The researchers spent more than six years following more than 8,000 middle-aged and older patients in 11 countries who had coronary artery disease or diabetes and at least one other risk factor, such as high blood pressure.

Read the full story at The Washington Post

Omega-3s in Fish Oils Tied to Healthy Aging

October 19, 2018 — Higher blood levels of omega-3 fatty acids, the fats found in fish, are linked to a healthier old age, according to a new study.

Researchers tracked 2,622 adults, average age 74 and healthy at the start of the study, from 1992 to 2015, looking to see if they continued to live without chronic diseases and without mental or physical problems.

The investigators measured blood levels of four common types of omega-3s: EPA and DHA, found in seafood; ALA, derived from plants; and DPA, which the body produces in small amounts.

After adjusting for many medical, dietary and lifestyle factors, they found that compared with people in the lowest one-fifth for omega-3 levels, those in the highest one-fifth had an 18 percent lower risk of unhealthy aging. The study appeared in BMJ.

Considered separately, EPA and DPA were associated with lowered risk of unhealthy aging, but DHA and ALA were not.

Read the full story at The New York Times

John McCain urges delay in new catfish inspection rules

September 1, 2017 — Sen. John McCain is mounting a last-minute plea to the U.S. Department of Agriculture to delay implementation of new catfish inspection rules slated to fully kick in Friday, saying all catfish inspections should be returned to the jurisdiction of the Food and Drug Administration.

Mr. McCain said the new inspection regime under the USDA’s Food Safety and Inspection Service (FSIS) is a thinly-disguised trade barrier against Asian catfish imports at the hands of domestic farmers in southern states.

“This wasteful program is a classic example of shortsighted, anti-free market protectionism at its worst,” Mr. McCain wrote in a letter to Agriculture Secretary Sonny Perdue this week.

“I request that you delay implementation of the USDA Catfish Inspection Program until Congress has an opportunity to reverse this duplicative, wasteful program,” he wrote.

Most fish is inspected by the FDA, but Congress — led by southern Republicans looking to protect their state’s industry — included language in the 2008 Farm bill that set the stage to transfer catfish inspections to a more intrusive process under FSIS.

Read the full story at the Washington Times