A newly revised federal guidance issued on March 28 specifically lists dietary supplements among critical infrastructure that can continue operating even amid the COVID-19 pandemic lockdowns happening nationwide. This document, titled “Guidance on the Essential Critical Infrastructure Workforce: Ensuring Community and National Resilience in COVID-19 Response Version 2.0,” was issued on March 28 by the Cybersecurity & Infrastructure Security Agency (CISA), part of the U.S. Department of Homeland Security.
Although an earlier version of CISA’s guidelines updated on March 19 did not specifically mention dietary supplements as essential services, many industry leaders said at the time they believed supplements would be considered essential because they fall under categories already deemed essential by CISA, including food and agriculture (dietary supplements fall under food-category regulations in the U.S.), healthcare/public health, and critical manufacturing.
Under the healthcare/public health category, the new March 28 CISA guidance now includes as critical infrastructure “manufacturer workers for health manufacturing…[including] dietary supplements.” CISA also specifies as essential “workers who support crucial supply chains and enable functions for critical infrastructure,” which likely includes companies along the dietary supplement supply chain, including ingredient suppliers, distributors, manufacturers, and testing labs (analytical laboratory services are also specifically listed as essential).
Those in the dietary supplement and natural products industries could additionally consider themselves essential according to the food and agriculture category of CISA’s March 28 guideline, which includes as essential “workers supporting groceries, pharmacies, convenience stores, and other retail (including unattended and vending) that sells food, animal/pet food and pet supply, and beverage products…”
It's important to note that the CISA list at the federal level does not automatically mean supplement companies can assume they can operate as essential services. Ultimately, it is states and local governments who make that decision.
The CISA federal guidelines state that they are only “advisory in nature” and are "not, nor should it be considered, a federal directive or standard." CISA’s guidelines note that “State, local, tribal, and territorial governments are responsible for implementing and executing response activities, including decisions about access and reentry, in their communities, while the federal government is in a supporting role. Officials should use their own judgment in issuing implementation directives and guidance.”
Nevertheless, the CISA list is likely to make dietary supplement companies operating throughout the U.S. feel more comfortable and confident that they would be considered essential services permitted to actively stay in business.
Michael McGuffin, president of the American Herbal Products Association (AHPA; Silver Spring, MD), advised dietary supplement companies to check their state and local rules to determine whether they continue operating, as the CISA guidelines are not federal mandates but rather advisory.
McGuffin’s press statement says: “AHPA appreciates that dietary supplement workers are now specifically identified as ‘essential critical infrastructure' in this latest guidance from the Department of Homeland Security. The guidance also reiterated its previous advice that other segments of food industry operations are essential, for example retail stores, testing laboratories, and more. Under the Federal Food, Drug, and Cosmetic Act and various state-law counterparts, dietary supplements qualify as ‘food,’ which in turn means that the references in the guidance to ‘food’ apply to dietary supplement product products and operations. However, as this guidance reiterates it is ‘advisory in nature’ and not ‘a federal directive or standard,’ companies and workers should check state and local recommendations and directives in making status determinations for operations that qualify as essential critical infrastructure.”
States Determine Which Businesses Can Operate
Individual states continue releasing guidelines on which businesses they consider essential and will continue to permit operating in their state. California is so far the only state that has specifically listed dietary supplements as business considered essential. Under the food and agriculture category for the state, California lists “workers supporting cannabis retail and dietary supplement retail” as essential workforce.
Ultimately, supplement manufacturers need to look at their own local orders and determine whether or not they would be authorized to stay in business.
Michael Jaffe, general counsel for The Vitamin Shoppe, told Nutritional Outlook on March 23: “In a state that has issued a 'Stay at Home Order,' except with respect to California, which has recently provided that supplement retailers are 'essential,' the decision of a retailer to keep its doors open is not automatic, but rather should be based on their own internal analysis as to whether their business is essential as defined by that particular state. A supplement retailer does not need an official sanction from a state to stay open. However, in the instance where a state has closed a specific business, in order to reopen, such business would have to apply to the applicable governor’s office for an exemption.”
Attorney Kevin Bell, partner at Arnall Golden Gregory LLP (AGG; Washington, DC), says: “I think these companies can treat themselves as essential, but it is a state-by-state decision right now. I think that in some states there may be more of a fight than in other states.”
Nutritional Outlook asked Daniel Fabricant, PhD, president and CEO of the Natural Products Association (Washington, DC), on March 25 whether he was aware of any state or local regulators trying to prohibit supplement business from operating. He said: “We haven’t seen anything formal in writing yet to shut people down. What we’ve heard is word of mouth. We’ve seen some people going around with health inspectors just telling businesses, ‘Hey, you may need to shut down,’ but we haven’t seen anything in writing yet.
He continued: “There have been a few states and localities to push back, and we’ve been successful in thwarting those—Puerto Rico being one—and so I think it’s important that our businesses, especially retail, stay open…We’re going to stay vigilant because you have to in these sorts of times.”
As Nutritional Outlook previously reported, dietary supplement, healthcare, and natural product industry associations, including NPA and AHPA, the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), and the United Natural Products Alliance (UNPA), have been active in requesting state and local governments to allow supplement businesses to remain in operation.
Should dietary supplement companies continuing to operate feel pretty comfortable and confident that they can do so? “Absolutely, and we’re not aware of any companies that have decided they are not essential,” said Steve Mister, president and CEO of CRN (Washington, DC), on March 24. "We’re not aware of any of those companies that have been challenged by their state or local authorities.”
During an AHPA webcast hosted on March 26, speaker and attorney Trent Norris, Esq., a partner at Arnold & Porter LLP (San Francisco), advised supplement companies continuing to operate to arm their employees with a letter "on your letterhead...[describing] why this employee needs to be working within your business, that your business is exempt." He also advised that companies ensure employees carry their company badge or ID with them at all times, and that companies appoint "a designated point person or a phone number that can be called by someone on the ground" if an employee is being challenged about continuing to actively work during the lockdowns.
Supplements Are Essential to Health, Industry Leaders Say
Dietary supplement businesses continue to make the case that they are a critical piece of the healthcare market—and that the nutrient gaps they help fill, and the health support they provide, are especially crucial during this time of the pandemic when consumer concerns about health and wellness are at an all-time high.
Brian Tanzer, manager of scientific affairs for The Vitamin Shoppe, told Nutritional Outlook on March 23: “Supplements include essential nutrients required for overall health and wellness. A significant percentage of the population doesn’t meet their need for several nutrients, including vitamin D and magnesium. If you add the current state of affairs to the equation, we may see an even further decline in the amount of people meeting their daily nutrient requirements. In addition to vitamins and minerals, on-the-go bars and drinks give people healthy options that are convenient and packed with nutrients.”
When asked whether supplements should be considered essential, CRN’s Mister said, “We are providing nutrition, so I think it’s very clear that we are part of the food supply. But the fact that we also provide healthcare benefits is well recognized by the fact that we’re allowed to make structure-function claims for our products, and in some cases to make health claims for the products. I think that clearly establishes us as being part of the healthcare manufacturing sector as well.”