By Sean Moloughney, Editor, Nutraceuticals World03.30.20
As more states urge residents to stay home to slow the spread of the coronavirus, on Mar. 28 the U.S. Department of Homeland Security (DHS) Cybersecurity & Infrastructure Security Agency (CISA) updated its guidance document regarding “essential” workers to include specific mention of dietary supplements.
This list is advisory and not a federal directive or standard, but is “intended to be overly inclusive,” reflecting the diversity of industries across the U.S. “Individual jurisdictions should add or subtract essential workforce categories based on their own requirements and discretion,” the document said.
Under the Healthcare/Public Health section, DHS lists: “Manufacturer workers for health manufacturing (including biotechnology companies), materials and parts suppliers, logistics and warehouse operators, distributors of medical equipment (including those who test and repair), personal protective equipment (PPE), isolation barriers, medical gases, pharmaceuticals (including materials used in radioactive drugs), dietary supplements, blood and blood products, vaccines, testing materials, laboratory supplies, cleaning, sanitizing, disinfecting or sterilization supplies, and tissue and paper towel products.”
Michael McGuffin, president of the American Herbal Products Association (AHPA) said the association appreciates that dietary supplement workers are now specifically identified as “essential critical infrastructure” in this latest guidance from DHS.
“The guidance also reiterated its previous advice that other segments of food industry operations are essential, for example retail stores, testing laboratories and more,” he said. “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 products and operations.”
However, since the guidance is advisory in nature, and not a federal directive or standard, McGuffin advised companies and workers to “check state and local recommendations and directives in making status determinations for operations that qualify as essential critical infrastructure.”
Businesses that continue to operate must make important modifications to protect workers, customers, and product safety based on guidance from the Centers for Disease Control and Prevention (CDC), the Occupational Safety and Health Administration (OSHA), and the Food and Drug Administration (FDA).
FDA Regulatory Revisions
In light of the coronavirus outbreak, FDA has made several temporary regulatory revisions, including the postponement of routine foreign and domestic inspections. On Mar. 10, the agency postponed most foreign inspections through at least April. FDA Commissioner Stephen Hahn, MD, said inspections outside the U.S. deemed “mission-critical” will still be considered on a case-by-case basis. That decision was largely based on travel restrictions and the need to protect health and safety of FDA employees.
And on Mar. 18, FDA temporarily postponed all domestic routine surveillance facility inspections. The agency said domestic for-cause inspection assignments will be evaluated and will proceed if “mission-critical,” noted Tara Lin Couch, PhD, senior director of dietary supplement and tobacco services, EAS Consulting Group, who spoke during a webinar presented by AHPA on Mar. 26.
Mission-critical inspections relate to Class I Recalls, foodborne outbreaks, or COVID-19 related situations, Couch said.
Without routine FDA inspections, self-monitoring and policing will become critical. FDA has stated, “Safety and quality need to be owned by the industry and firms have the primary responsibility to reliably produce quality products.”
As such, facilities “must adhere to Current Good Manufacturing Practice (cGMP) requirements pertaining to, for example, operating procedures, manufacturing, sanitation, and processing controls, as well as preventive controls to reduce or eliminate food safety hazards,” according to the agency.
In other noteworthy commentary that Couch highlighted during AHPA’s webinar, FDA said it believes regulated firms “understand and appreciate their shared responsibility to ensure the integrity of the supply chain and we will continue to communicate with them during this time to underscore this partnership.”
FDA also said it won’t enforce supplier verification onsite audit requirements for receiving facilities and importers under the Food Safety Modernization Act (FSMA), provided other supplier verification methods are used instead.
Acknowledging that both industry and FDA workforces may be reduced, and resources limited, the agency issued guidance that Serious Adverse Event (SAE) reports can be “stored” and reported to FDA within 6 months after the restoration of normal activities. “As much compliance and continuity with company complaint processes and SAE reporting requirements should be maintained as possible,” the agency said.
Once a “pre-pandemic state has been restored,” firms will be expected to resume fulfilling all SAE reporting requirements on time as well as submit reports that were stored because of the pandemic.
Test to Verify
With inspections and other regulatory measures on hold and scaled back, an industry considered essential by the federal government—working during the gravest public health emergency in a century—is largely operating on an honor system. What effect might that have on quality?
“It’s like that stop sign that people always role through in my neighborhood,” said Elan Sudberg, CEO, Alkemist Labs. “Sometimes the cops will post up and remind people, via costly tickets, how stop signs work. Well, now there has been a press release to all that there will be no cops at that stop sign. I have a suspicion as to what will follow for some companies. There are others that don’t need fear of the police to do the right thing, though. As we’re seeing at our lab, when sales go up in our industry, our clients test more because they know they need to test all lots and batches.”
Still, the door is open for bad actors to gain ground, or for more companies to cut corners. And with increased demand for health products during the pandemic, “adulteration just got a free pass,” said Sudberg. “So did the substandard FDA 483 holding labs still active in our industry. FDA just said, ‘we are not looking.’ Couple that with extreme supply and demand challenges as our clients frantically try to resupply the stores with their products by quickly buying more ingredients and this could be a major problem.”
The supply chain was already strained by trade wars, and now COVID-19 has impacted access to shipping supplies, he added. “As brands scramble to get ingredients, they absolutely need to step up their testing to make sure they know what they are working with before they put their label on it.”
A critical link in an essential industry, credible testing labs can help brands and manufacturers recommit to self-policing, “because their risk just went way up,” Sudberg said. “Advantages will be exploited and if trust is relied upon sans verification, damage will be done.”
Alkemist has adapted its operations during the outbreak in a number of ways while keeping up with increased demand. “Anyone who can work from home has been set up to do so. We have done our best to accommodate anyone who is considered high risk in a variety of ways,” Sudberg noted. “We’re following all the protocols of the CDC and WHO, and sanitizing like crazy. And we are very busy. Our clients are in a pinch with sales through the roof and the need to get those orders out the door. We are here to help get their ingredients qualified for use in their products ASAP.”
Now is not the time to “profiteer off this terrible situation,” Sudberg added, “either by making drug claims on products or hawking unproven technology. It is important to continue to communicate necessary information to our staff, clients, and customers. I try to live by these gates: Is it true? Is it necessary? Is it kind? Usually those gates keep you above the line.”
Ultimately, with so many people relying on dietary supplements and other nutritional products to support their health and well-being, testing labs play a crucial role in ensuring products that brands sell “are what they say they are, and nothing else,” Sudberg said. “We in our industry are incredibly fortunate that we are providing essential goods and services and can continue to work, so we will need to step up to help others.”
This list is advisory and not a federal directive or standard, but is “intended to be overly inclusive,” reflecting the diversity of industries across the U.S. “Individual jurisdictions should add or subtract essential workforce categories based on their own requirements and discretion,” the document said.
Under the Healthcare/Public Health section, DHS lists: “Manufacturer workers for health manufacturing (including biotechnology companies), materials and parts suppliers, logistics and warehouse operators, distributors of medical equipment (including those who test and repair), personal protective equipment (PPE), isolation barriers, medical gases, pharmaceuticals (including materials used in radioactive drugs), dietary supplements, blood and blood products, vaccines, testing materials, laboratory supplies, cleaning, sanitizing, disinfecting or sterilization supplies, and tissue and paper towel products.”
Michael McGuffin, president of the American Herbal Products Association (AHPA) said the association appreciates that dietary supplement workers are now specifically identified as “essential critical infrastructure” in this latest guidance from DHS.
“The guidance also reiterated its previous advice that other segments of food industry operations are essential, for example retail stores, testing laboratories and more,” he said. “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 products and operations.”
However, since the guidance is advisory in nature, and not a federal directive or standard, McGuffin advised companies and workers to “check state and local recommendations and directives in making status determinations for operations that qualify as essential critical infrastructure.”
Businesses that continue to operate must make important modifications to protect workers, customers, and product safety based on guidance from the Centers for Disease Control and Prevention (CDC), the Occupational Safety and Health Administration (OSHA), and the Food and Drug Administration (FDA).
FDA Regulatory Revisions
In light of the coronavirus outbreak, FDA has made several temporary regulatory revisions, including the postponement of routine foreign and domestic inspections. On Mar. 10, the agency postponed most foreign inspections through at least April. FDA Commissioner Stephen Hahn, MD, said inspections outside the U.S. deemed “mission-critical” will still be considered on a case-by-case basis. That decision was largely based on travel restrictions and the need to protect health and safety of FDA employees.
And on Mar. 18, FDA temporarily postponed all domestic routine surveillance facility inspections. The agency said domestic for-cause inspection assignments will be evaluated and will proceed if “mission-critical,” noted Tara Lin Couch, PhD, senior director of dietary supplement and tobacco services, EAS Consulting Group, who spoke during a webinar presented by AHPA on Mar. 26.
Mission-critical inspections relate to Class I Recalls, foodborne outbreaks, or COVID-19 related situations, Couch said.
Without routine FDA inspections, self-monitoring and policing will become critical. FDA has stated, “Safety and quality need to be owned by the industry and firms have the primary responsibility to reliably produce quality products.”
As such, facilities “must adhere to Current Good Manufacturing Practice (cGMP) requirements pertaining to, for example, operating procedures, manufacturing, sanitation, and processing controls, as well as preventive controls to reduce or eliminate food safety hazards,” according to the agency.
In other noteworthy commentary that Couch highlighted during AHPA’s webinar, FDA said it believes regulated firms “understand and appreciate their shared responsibility to ensure the integrity of the supply chain and we will continue to communicate with them during this time to underscore this partnership.”
FDA also said it won’t enforce supplier verification onsite audit requirements for receiving facilities and importers under the Food Safety Modernization Act (FSMA), provided other supplier verification methods are used instead.
Acknowledging that both industry and FDA workforces may be reduced, and resources limited, the agency issued guidance that Serious Adverse Event (SAE) reports can be “stored” and reported to FDA within 6 months after the restoration of normal activities. “As much compliance and continuity with company complaint processes and SAE reporting requirements should be maintained as possible,” the agency said.
Once a “pre-pandemic state has been restored,” firms will be expected to resume fulfilling all SAE reporting requirements on time as well as submit reports that were stored because of the pandemic.
Test to Verify
With inspections and other regulatory measures on hold and scaled back, an industry considered essential by the federal government—working during the gravest public health emergency in a century—is largely operating on an honor system. What effect might that have on quality?
“It’s like that stop sign that people always role through in my neighborhood,” said Elan Sudberg, CEO, Alkemist Labs. “Sometimes the cops will post up and remind people, via costly tickets, how stop signs work. Well, now there has been a press release to all that there will be no cops at that stop sign. I have a suspicion as to what will follow for some companies. There are others that don’t need fear of the police to do the right thing, though. As we’re seeing at our lab, when sales go up in our industry, our clients test more because they know they need to test all lots and batches.”
Still, the door is open for bad actors to gain ground, or for more companies to cut corners. And with increased demand for health products during the pandemic, “adulteration just got a free pass,” said Sudberg. “So did the substandard FDA 483 holding labs still active in our industry. FDA just said, ‘we are not looking.’ Couple that with extreme supply and demand challenges as our clients frantically try to resupply the stores with their products by quickly buying more ingredients and this could be a major problem.”
The supply chain was already strained by trade wars, and now COVID-19 has impacted access to shipping supplies, he added. “As brands scramble to get ingredients, they absolutely need to step up their testing to make sure they know what they are working with before they put their label on it.”
A critical link in an essential industry, credible testing labs can help brands and manufacturers recommit to self-policing, “because their risk just went way up,” Sudberg said. “Advantages will be exploited and if trust is relied upon sans verification, damage will be done.”
Alkemist has adapted its operations during the outbreak in a number of ways while keeping up with increased demand. “Anyone who can work from home has been set up to do so. We have done our best to accommodate anyone who is considered high risk in a variety of ways,” Sudberg noted. “We’re following all the protocols of the CDC and WHO, and sanitizing like crazy. And we are very busy. Our clients are in a pinch with sales through the roof and the need to get those orders out the door. We are here to help get their ingredients qualified for use in their products ASAP.”
Now is not the time to “profiteer off this terrible situation,” Sudberg added, “either by making drug claims on products or hawking unproven technology. It is important to continue to communicate necessary information to our staff, clients, and customers. I try to live by these gates: Is it true? Is it necessary? Is it kind? Usually those gates keep you above the line.”
Ultimately, with so many people relying on dietary supplements and other nutritional products to support their health and well-being, testing labs play a crucial role in ensuring products that brands sell “are what they say they are, and nothing else,” Sudberg said. “We in our industry are incredibly fortunate that we are providing essential goods and services and can continue to work, so we will need to step up to help others.”
