FDA accommodating to COVID-19
On September 18, the US Food and Drug Administration unveiled the most recent in a line of programs designed to give food manufacturers who are finding it difficult to modify their operations and procedures in order to guarantee food is directed safely and in the quantities and forms needed during the coronavirus (COVID-19) pandemic, a temporary reprieve from the enforcement of specific regulations and deadlines.
The FDA indicated in a recent announcement that it will give manufacturers more leeway if they have to comply with the new Nutrition and Supplement Facts label requirements by January 1, 2021. Manufacturers who have yearly food sales of less than $10 million are subject to the impending compliance date.
The FDA stated that while the compliance deadline will still apply, it will not be concentrating on taking enforcement action against these smaller food makers in 2021.
The FDA stated that by declaring it would not concentrate on enforcement proceedings in 2020, it gave firms with $10 million or more in yearly sales the same latitude, even though they were still obliged to comply with the Nutrition and Supplement Facts label standards by January 1, 2020.
A well-tuned food production and distribution system was turned upside down by the US COVID-19 pandemic, upsetting food manufacturers, distributors, and entire industries, like foodservice, off balance.
According to the FDA, enforcement action against these smaller food companies will not be the focus of its efforts in 2021, even if the compliance deadline would still apply.
The FDA claimed that by announcing that it would not focus on enforcement actions in 2020, it granted the same flexibility to companies with annual sales of $10 million or more, despite the fact that these companies were still required to adhere to the Nutrition and Supplement Facts label requirements by January 1, 2020.
The US COVID-19 epidemic threw a well-oiled food production and distribution system into a loop, throwing food manufacturers, distributors, and entire industries—like foodservice—off balance.
These and other temporary changes have allowed the food industry to successfully respond to the crisis.
“What was appreciated by industry was not only what FDA did, but what other regulatory agencies did as well,” Betsy Booren, PhD, senior vice president, regulatory and technical affairs, Consumer Brands Association, told Food Business News. “The flexibilities they announced allowed consumer products, whatever they might be, to get to consumers sooner.”
Dr. Booren provided a couple of examples. She pointed out the pandemic emerged just as baseball season was set to begin, and a lot of extra food was being directed to the foodservice sector. She credited the FDA and the FSIS for providing, within parameters, the flexibility the food industry required to reposition that food and direct it into retail marketing channels.
“The food industry was able to provide a lot of good food to retailers and consumers and prevent wastage,” she said.
She also discussed the FDA’s temporary flexibility that allowed food manufacturers to substitute similar minor ingredients for original ingredients that could not be accessed because of disrupted supply lines, as long as there was not an allergen or other food safety issue.
“The FDA provided an example wherein one could use bleached flour in place of unbleached flour if unbleached flour was unavailable,” Dr. Booren stated. Usually, that would mean renaming things. Because of this flexibility, fundamental products may still be manufactured and delivered.
According to Dr. Booren, some of the COVID-19 temporary policies may spark debate about what should be kept in place or, at the very least, what can be learned from the experience.
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Dr. Booren stated, “Can we streamline unnecessary in-person interaction” by using new technology. For example, in-person inspections and audits of food production facilities are required and will continue.
Food Business News was informed by David Acheson, president and chief executive officer of The Acheson Group, that “temporary” is the crucial word in the FDA’s disclosed flexibilities.
“The FDA has been accommodating with routine work, but it is pursuing work related to causes and follow-ups on previous investigations and outbreaks,” stated Mr. Acheson. “In general, they will probably gradually increase routine inspections and eventually need to return to the level of inspections that Congress has mandated, but that could take some time.”
Additionally, Mr. Acheson pointed out that the FDA’s Foreign Supplier Verification Program has exhibited considerable flexibility.
“However, importers have received a lot of warning letters regarding FSVP,” he claimed. “I believe that routine international inspections by the FDA will resume, but not until COVID-19 is significantly more under control.
“There have been some short-term adjustments, but these don’t seem to be permanent.”