COVID-19 restrictions: FDA pauses US inspections as NPA insists health food stores remain open

19 Mar 2020 --- The US Food and Drug Administration (FDA) has temporarily postponed all domestic routine surveillance facility inspections to protect the health of its staff during the ongoing COVID-19 outbreak. This will apply to all FDA-regulated products, including food, drugs, biological products and devices. Tightening restrictions in the US have also led the Natural Products Association (NPA) to call for health food stores to remain open as retailers are increasingly forced to shutter.

“During this interim period, we’re evaluating additional ways to conduct our inspectional work that would not jeopardize public safety but protect both the firms and the FDA staff. This can include, among other things, evaluating records in lieu of conducting an onsite inspection on an interim basis when travel is not permissible, when appropriate,” states the FDA. 

The facility inspections are traditionally conducted every few years based on a risk analysis. The FDA notes that the inspections are just one aspect of a multi-pronged approach to overseeing the safety and quality of products.

“Safety and quality need to be owned by the industry and firms have the primary responsibility to reliably produce quality products. For example, the medical product and food industries we regulate are subject to certain reporting requirements about their facilities and also must adhere to Current Good Manufacturing Practice requirements,” the FDA highlights. 

Earlier this month, the organization also decided to postpone most foreign facility inspections through April. Inspections outside the US that are deemed mission-critical will be considered on a case-by-case basis as this outbreak continues to unfold.

The fight to keep health food stores open
The rise of COVID-19 has also led to concern from the NPA that natural products retailers may close. The organization has called on the governors of all 50 US states to deem health food stores selling nutritional supplements “essential businesses” and to allow small businesses to request for Economic Injury Disaster Loan assistance.

“Natural products retailers are essential to the health of local economies and millions of Americans across the country. It is critical for these small businesses to stay open and receive the assistance necessary to make it through this public health crisis. To date, only four states have made the request to Small Business Administration for the bridge funding. Small businesses – the lifeblood of any industry – need that funding made available nationwide,” says Daniel Fabricant, President and CEO of NPA.

Over the last few days, many states and territories have begun to order the closure of most businesses for an indefinite period. Exempt businesses currently include supermarkets, pharmacies, restaurants offering carryout or delivery, medical equipment stores, gas stations and banks. By keeping health food stores open, people will gain another way to acquire essential products, including water, electrolytes, nutritional supplements, healthy food options and other health-related products such as hand sanitizer.

Earlier this month, PharmaLinea Founder Blaž Gorjup told NutritionInsight that although COVID-19 has led to product launches being put on hold, the supplement market is still seeing a boost in sales. 

Three in every four US consumers use at least one natural product, according to the NPA.Addressing Trump directly
The organization has also presented its plea in a letter to US President Donald Trump. NPA uses the example of NOW Foods, which uses a manufacturing and distribution center in Nevada to provide dietary supplement products for retailers nationwide. 

“We are concerned about situations like [the potential closure of NOW Foods], as it will not only limit access to vital health products for millions of US consumers, but it could also force consumers to seek overseas products. As we navigate this health and economic crisis, we do not believe it is the appropriate action to increase our reliance on products sold outside of the US,” states the letter. 

According to the NPA, three in every four US consumers use at least one natural product and the natural products industry is responsible for over 380,000 direct jobs, US$16 billion in direct wages and almost US$15 billion in taxes each and every year. 

“It is imperative that essential businesses such as health-food stores that provide nutritional supplements and other health and wellness products remain open for business,” continues Fabricant. “Local businesses are an essential resource for US residents in times like these, especially people at risk, who need access to neighborhood stores. Communities need these stores open and we are asking lawmakers to lift any order as it relates to health food stores.”

Earlier this year, the NPA called on the FDA to clamp down on products claiming to prevent or treat COVID-19. The FDA then warned seven such companies and is concerned that these products could cause consumers to delay or stop appropriate medical treatment, leading to serious and life-threatening harm. 

By Katherine Durrell

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