In the space of a few short weeks, what we thought of as our comfortable reality was changed; probably forever. In February, the most important thing was finding a potential pathway to market for CBD. By mid-March, everyone’s primary concern seemed to be a search for an adequate supply of toilet paper and perhaps washing their hands for 20 seconds many times a day. By the end of May, a mere two months later, the everyday act of just going to a retail store caused some level of legitimate fear for many customers and employees as we practiced social distancing, while wearing masks and disinfecting everything that they touched. In New York State, for example, the governor has even issued an executive order requiring store owners to deny entry to people without masks.

Many health food retailers have reacted to the pandemic by selling alcohol-based hand sanitizers, which are regulated as over-the counter (OTC) drugs by the U.S. Food and Drug Administration (FDA). At the start of the crises these products all but disappeared from store shelves. Fortunately, FDA took immediate steps to increase their availability by issuing three emergency policies. The first allowed companies that were not currently registered drug manufacturers to temporarily register as OTC drug manufacturers to prepare alcohol-based hand sanitizers during the COVID-19 public health emergency. The second policy permitted pharmacies and registered outsourcing facilities to temporarily compound certain alcohol-based hand sanitizers. Finally, the third enabled alcohol production firms, such as those that might otherwise be making liquor to temporarily produce alcohol for incorporation into alcohol-based hand sanitizers during the COVID-19 public health emergency (www.fda.gov/drugs/coronavirus-covid-19-drugs/hand-sanitizers-covid-19). The quick action from FDA, helped to get a wide variety of these suddenly crucial products quickly back on store shelves.

Many health food retailers are also concerned about marketing disinfectants that are used to clean surfaces. These products are regulated by the Environmental Protection Agency (EPA). To assist retailers that sell disinfectants and consumers looking to purchase them, the EPA has created “List N: Disinfectants for Use Against SARS-CoV-2”, which are a list of products that meet EPA’s criteria for use against the virus that causes COVID-19 (www.epa.gov/pesticide-registration/list-n-disinfectants-use-against-sars-cov-2).

According to the EPA, while surface disinfectant products on List N have not been tested specifically against SARS-CoV-2, the cause of COVID-19, because it is a new virus and not readily available for commercial testing, EPA nevertheless expects them to kill the virus because they: “demonstrate efficacy (e.g. effectiveness) against a harder-to-kill virus; or demonstrate efficacy against another type of human coronavirus similar to SARS-CoV-2.” Obviously, retailers adding these products to their store shelves should ensure that their active ingredients are on the EPA List N.

In addition, once it became known that there are actually a large number of people that contract the virus but are asymptomatic (those that are infected with the virus and can spread it to others but do not feel sick or have any symptoms; consider the example of “Typhoid Mary” as an historical reference), face masks and face shields became highly recommended, if not required by state law and are now being offered for sale by many health food retailers. The primary purpose for wearing a mask, even a paper “surgical” mask or one made from old clothes or a bandana is to add a layer of protection to help prevent those people that are asymptomatic from unknowingly spreading the virus to others. Other recommendations, which may be important to retailers concerning masks, include the fact that N95 respirators, which are among the most effective, be reserved for medical staff and, thus not sold to consumers. And, that many of the masks with little plastic valves embedded in them allow exhaled breath to bypass the filter and be expelled, which defeats the purpose of wearing the mask, which is to keep your breath in as much as possible. So, these masks, which are primarily for protection against dust, should not be sold for COVID-19 purposes.

Many health food retailers are also selling gloves, although health authorities are only recommending the use of gloves when cleaning or caring for someone who is sick. General advice is that frequent “20 second” hand washing and not touching one’s face is more effective than the general use of gloves, particularly when people have not been adequately trained in their use.

Obviously, health food retailers are also continuing to sell vitamins, minerals and other dietary supplements for a wide variety of benefits. It is perfectly acceptable to continue to market dietary supplements with structure/function benefit claims. There are even stories in the reputable news media that discuss the potential benefits of various dietary supplements in treating or preventing COVID-19. Whether or not any of these reported benefits are ever proven true, it is critical that companies marketing products and retailers selling them, do not make any express or even implied COVID-19 benefit claims. For example, while it is certainly acceptable to promote the general benefits of immune supporting dietary supplements, marketing them with store signs promoting benefits “in this time of crisis” could be seen as implying a benefit against COVID-19, which would be illegal. FDA, the Federal Trade Commission (FTC), and the U.S. Department of Justice (DOJ) have been extremely vigilant in their enforcement efforts and more than 120 companies and individuals have been cited for attempting to profit by marketing illegal COVID-19 products. For example, on May 21, FTC announced that it had sent letters warning 50 more marketers to stop making unsupported claims that their products and therapies can effectively prevent or treat COVID-19 (www.ftc.gov/news-events/press-releases/2020/05/ftc-sends-letters-warning-50-more-marketers-stop-making). (Most of the letters were to companies marketing products that claimed to be supplements or “Chinese herbal treatments”).

FDA has taken steps to help ensure the continued availability of the food supply during the pandemic. For example, in March, FDA announced that it would permit food manufacturers that have inventory on hand labeled for use in restaurants (which generally does not have a Nutrition Facts box) to be sold at retail provided that the food does not have any nutrition claims and contains other required information on the label, including: a statement of identity, an ingredient statement, the name and place of business of the food manufacturer, packer, or distributor, net quantity of contents, and allergen information required by the Food Allergen Labeling and Consumer Protection.

Retailers should also be aware that on May 22, 2020, the FDA issued a Temporary Policy Regarding Certain Food Labeling Requirements During the COVID-19 Public Health Emergency: Minor Formulation Changes and Vending Machines (www.fda.gov/media/138315/download). The agency’s goal is to provide regulatory flexibility to help minimize the impact of potential supply chain disruptions on product availability associated with pandemic. For example, FDA will allow manufacturers to make minor formulation changes in certain circumstances without making conforming label changes. FDA would consider such formulation changes to be minor if they do not cause any safety issues (for example, no change in allergens, glutens, sulfites or other ingredients with known sensitivities); generally present at or less 2 percent or less by weight of the finished food; the substituted ingredient is not a “major” or “characterizing” ingredient in the product (for example, you cannot substitute something else for the raisins in raisin bread); and the substitution cannot have a “significant impact” on the finished product, including nutritional differences or functionality. Some FDA examples of this policy include allowing the use of unbleached flour, instead of bleached flour (which there have been shortages of), substituting small amounts of a different type or source of vegetable oil or omitting a small amount of one vegetable in a multi-vegetable product. Ideally, retailers should be advised of such changes, so they can alert their customers, but this may not always be the case.

FDA is providing temporary flexibility to the vending machine industry and will not object if covered operators do not meet vending machine labeling requirements to provide calorie information for foods sold in the vending machines at this time.

Finally, in May, FDA issued a guidance on “Best Practices for Re-Opening Retail Food Establishments During the COVID-19 Pandemic” (www.fda.gov/food/food-safety-during-emergencies/best-practices-re-opening-retail-food-establishments-during-covid-19-pandemic). In this release, FDA included a document in the form of a “Food Safety Checklist,” which should be reviewed and instituted by every retail food establishment (www.fda.gov/media/137867/download) and a two page “Infographic” that should be reviewed and posted for all store employees (www.fda.gov/media/137868/download).

The Checklist includes important information for retailers such as sections on “Facility Operations” that includes checks for posting signs on how to stop the spread of COVID-19; making certain the premises is in good order, including utilities and equipment; that all areas of the food establishment, including bathrooms and waiting areas are properly cleaned, sanitized and disinfected; that there is increased circulation of outdoor air by opening windows, doors and using fans all to the extent possible; and finally that any “high touch self-service containers and items requiring frequent hand contact” have been removed from use or appropriately washed, cleaned and sanitized, and/or changed as much as possible.

The checklist also includes information on ensuring the safe use of portable water and ice machines and bins, and the need to clean, disinfect and sanitize food and non-food contact surfaces. For example:

Are necessary sanitizers and disinfectants that meet EPA’s criteria [discussed above] for use against SARS-CoV-2 available and used per label instructions to clean and disinfect the facility during hours of operation?

Are high-touch areas and equipment cleaned and disinfected (e.g. door knobs, display cases, equipment handles, check-out counters, order kiosks and grocery cart handles)?

Are food contact surfaces and counters cleaned and sanitized? (Wash, rinse and sanitize food contact surfaces, food preparation surfaces and beverage equipment after use.)

Are staff properly trained on cleaning procedures to ensure safe and correct application of disinfectants?

Has a disinfection schedule or routine plan been developed? Ensure sufficient stocks of cleaning and disinfecting supplies to accommodate ongoing cleaning and disinfection.

Sections of the checklist specific to COVID-19 concern Employee Health/Screening with checks for:

Do you have a protocol to check employee health and personal hygiene practices within your food establishment?

Are you following CDC (Centers for Disease Control and Prevention) guidance and practices for employee health checks/screenings?

Have you checked CDC and local regulatory/health authority guidance for employees returning back to work?

Is there a plan to monitor and respond to a higher than normal level of absenteeism?

Is there a plan or policy for, and an adequate supply of, personal protective equipment (PPE) and/or cloth face coverings? Cloth face coverings should only be used if PPE is not required, and changed as needed if worn.

And, efforts to maintain social distancing in establishments are included in the Checklist with suggestions of using tape on floors/sidewalks, erecting partitions and placing signage on walls to minimize face-to-face contact that allows, to the extent possible, at least a 6-foot distance between workers, customers, and visitors; limiting self-serve food or drink options, such as buffets, salad bars and drink stations; and restricting the number of employees in shared spaces, including kitchens, break rooms, and offices to maintain at least a 6-foot distance between people.

Eventually, as all things do, this will pass, and we will get back to some semblance of what we used to consider normal. Although, hopefully, we will remember some of the lessons learned from this unfortunate pandemic and continue their use for our future safety and well-being. VR

Steven Shapiro is of counsel to Rivkin Radler LLP (rivkin.com) and a partner of Ullman, Shapiro & Ullman, LLP (usulaw.com). His practice focuses on the dietary supplement/natural products industries with a particular emphasis on FDA and FTC compliance issues including labels, labeling and advertising claims.