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FDA leaning on tools other than inspections in coronavirus response

While FDA can’t test products in China during the coronavirus outbreak, it is utilizing other regulatory tools to react to potential product issues sourced from areas affected by the virus.

Amid growing concern about the safety of products imported from China, stricken with an outbreak of the deadly coronavirus 2019 (COVID-19), FDA this week said it is leaning on a provision of the Federal Food, Drug and Cosmetic Act (FD&C) to request records from product suppliers, in lieu of actual inspections in China that have come to a halt due to travel restrictions related to the outbreak.

“While we are not able to conduct inspections in China right now, this is not hindering our efforts to monitor medical products and food safety. We have additional tools we are utilizing to monitor the safety of products from China, and in the meantime, we continue monitoring the global drug supply chain by prioritizing risk-based inspections in other parts of the world,” the agency said in a statement.

By requesting records “in advance or in lieu of” drug surveillance inspections in China—additional authority provided the agency by Congress to improve the effectiveness and efficiency of inspections, the agency said—FDA hopes that when inspections resume, it will be able to prioritize the products deemed the most necessary for inspection.

FDA said the records requests would occur in conjunction with the other, though limited, tools at its disposal, including working with U.S. Customs and Border Protection to target imported products that violate FDA regulations and “aggressively” monitoring the market for products making fraudulent claims related to the spread of COVID-19, also known as the novel coronavirus.

Deceitful claims related to the virus are of particular concern for those in the dietary supplement industry. Earlier this month, four leading trade associations in the space spoke with one voice as dishonest claims about supplements began to spread.

“While research supports the use of certain dietary supplements to maintain immune system health, we are not aware of clinical research that demonstrates using a dietary supplement specifically to prevent or to treat the Novel Coronavirus,” the four associations—the American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), and the United Natural Products Alliance (UNPA)—wrote in a joint press release.

The improvised industry consortium urged marketers and retailers to refuse to stock or sell supplements with questionable coronavirus claims, refrain from promoting any product as a cure, and reminded customers they should avoid any product claiming to treat, cure or prevent coronavirus.

On-the-ground impact

Supplement and natural products companies that rely on Chinese links in their supply chain are still gauging the effects on their businesses, as factories slowly come back online and transportation systems begin to start back into service.

Whether suppliers are producing again depends a lot on location within China, as many facilities far from the epicenter of the outbreak—Hubei province and the city of Wuhan, specifically—were able to restart production earlier this month, following the Chinese New Year holiday break that coincided with the outbreak of the virus.

Doug Brown, sales and marketing director at Sirio, a contract manufacturer headquartered in Guangdong province—far from the areas hardest hit by the virus—said Sirio’s facilities were “fully operational” as of about Feb. 10.

Scott Steinford,  executive director for the CoQ10 Association and also CEO of Health Wright Products, a contract manufacturer with numerous Chinese suppliers, said he expects some supply chain disruption to persist, especially as pertains to ubiquinol, the primary form of coenzyme Q10 (CoQ10) that makes up 90% of the market and almost exclusively comes from Chinese suppliers.

“While we have encountered similar outbreaks like SARS [severe acute respiratory syndrome] and MERS [Middle East respiratory syndrome], the level of reliance on Chinese manufacturing is dramatically different than the days when the primary output from China was T-shirts and plastic products,” Steinford explained.

Others, like import-export business owner Bruce Kneller, were far more concerned about lasting disruption on the natural products and supplement industries heavily reliant on Chinese ingredients, particularly herbal components made, processed and packaged nearly exclusively in the outbreak’s hardest hit region.

“Right now nothing is being made. Or very little. And even the stuff that’s being made can’t necessarily be transported to port because there are no truck drivers that are willing to travel between provinces or even cities,” Kneller said late last week.

Industry events impact

Travel restrictions surrounding the virus have had a major impact on current and future industry events planned across the globe.

The industry-spanning Natural Products Expo West is set to take place next week, March 3-7 in Anaheim, California, and while organizers said it’s “entirely business as usual” for the show, more food safety advisors and health and safety resource professionals reportedly will be on the show floor this year in addition to more handwashing and hand-sanitizer stations throughout the expo area.

The show also listed dozens of companies either based—or with deep roots—in China that canceled plans to attend.

At the U.S.-China Health Products Association, a number of conference events scheduled for February had to be canceled. The group also provided guidance on a number of other upcoming industry events.

Food Ingredients China (FIC)—originally set for March 17-19 in Shanghai—has been postponed until a later rescheduling date can be determined, likely toward the end of June.

The Natural Health and Nutrition Expo (NHNE), originally scheduled for April 8-10 in Shanghai, has been pushed back to May 27-29.

The co-located HiFi Asia-China and HealthPlex NPC shows, both organized by Informa in conjunction with the China Chamber of Commerce, are planning to proceed as scheduled June 22-24 in Shanghai.

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