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Jennifer Grebow is editor-in-chief of Nutritional Outlook.
With dietary supplement supply chains facing potential interruptions due to the global COVID-19 pandemic, and with FDA ceasing routine facility inspections, what will the impact be on dietary supplement safety and quality?
Many dietary supplement manufacturers are relieved to hear that, so far, the COVID-19 pandemic has not had a negative effect on supplement sales overall. It remains to be seen whether that positive picture changes for certain supplement categories moving forward as the world moves deeper toward a recession.
Looking ahead, what challenges will the supplement industry grapple with as a result of COVID-19? One primary concern is whether there will negative supply chain effects that could ultimately lower the safety and quality of dietary supplements.
First: Supplements Are Safe
First and foremost, FDA emphasizes that the novel coronavirus cannot be transmitted through dietary supplements or their packaging. FDA says on its website: “Currently, there is no evidence of food or food packaging being associated with transmission of COVID-19.”
Nutritional Outlook asked a handful of dietary supplement industry leaders, as well as some supplement manufacturers, whether they’ve heard that consumers are largely fearful that they could contract coronavirus from dietary supplements. They said no.
Rather, the internal concerns regarding supplement safety are more fixated on whether or not factors such as limited FDA oversight during this time, coupled with the possibility of increased economic adulteration due to supply shortages, could create risk of unsafe and low-quality ingredients and manufacturing within the supplement market in the future.
FDA Scales Back Inspections, SAER Requirements
Social distancing requirements spurred by the pandemic have led FDA to scale back on both foreign and domestic routine facility inspections, including at food facilities-and, under that umbrella, dietary supplement facilities. These routine inspections are critical in ensuring that dietary supplements are being produced according to current Good Manufacturing Practices (cGMPs).
Coronavirus, however, has made performing these routine physical inspections dangerous. Thus, on March 10, FDA announced it has postponed most foreign facility inspections through April, citing burdens including protecting its staff as well as global travel restrictions. A week later, on March 18, FDA announced it has also scaled back on routine domestic inspections.
In both cases, FDA said it is restricting inspections to “mission critical” cases. “Mission critical” means Class I recalls-recalls related to foodborne illness outbreaks or related to the COVID-19 pandemic itself, said Tara Lin Couch, PhD, senior director of dietary supplement and tobacco services at EAS Consulting Group LLC (Alexandria, VA). Couch made her comment during a webcast presentation hosted on March 26 by the American Herbal Products Association (AHPA; Silver Spring, MD).
In lieu of physical site inspections, FDA has said it will rely on other means of regulating companies. Said Couch during the AHPA webcast: “Some of these alternative methods and tools that they referenced in regards to these foreign inspection delays is denying entry of unsafe products into the U.S.-so, obviously, border control can help to facilitate that process; doing physical examinations or sampling of products and materials at the border; reviewing the firm’s previous compliance history…Also, informing the foreign governments and working with them in advance in lieu of on-site inspections.” In place of domestic site inspections, FDA would rely on similar tools, including records review.
When announcing FDA’s suspension of routine domestic inspections, FDA Commissioner Stephen Hahn, MD, said manufacturers should continue to follow cGMPs, even if they aren’t being inspected. Said Hahn: “Inspections are just one part of a robust and multi-pronged approach to overseeing the safety and quality of FDA-regulated products; however, inspections are not what cause quality to happen. Safety and quality need to be owned by the industry, and firms have the primary responsibility to reliably produce quality products.”
FDA has further scaled back requirements for serious adverse event reporting (SAER) during the time of the pandemic. Whereas food and supplement companies are typically required to report serious adverse events to FDA within 15 business days upon being notified of the event, on March 20, the agency, citing FDA staff shortages during the pandemic, updated its rule to allow companies to instead keep track of SAERs and report them to FDA “within six months of the restoration of adverse event reporting processes to their pre-pandemic state”-another pullback of the agency’s immediate oversight.
Own Their Own
Will FDA’s alternative oversight measures be enough to ensure that companies producing supplements continue to adhere to cGMPs and continue to produce safe and quality products? Can FDA rely on supplement brands to be on their best behavior?
Some are fearful that FDA, by making it broadly known that the agency is no longer routinely inspecting manufacturers, has opened the door to bad actors.
“The part I didn’t like was announcing that they are essentially not doing any inspection of foreign facilities-in essence, telling the industry, ‘You’re on your own for a little bit. You’re going to have to govern yourself for a little bit.’ That’s really what they told them,” says attorney Kevin Bell, partner at Arnall Golden Gregory LLP (AGG; Washington, DC).
Having worked in the industry for many years, Bell says, “You get to know a lot about who cares about what…which contract manufacturers cut corners, which ones don’t, and which ones don’t get caught violating cGMPs. I find it humorous that there’s a belief that every contract manufacturer out there in the United States is following their cGMPs and that it’s just a few that don’t.”
He continues: “And then when you start talking about not doing inspections of foreign facilities? That’s close to a license to steal, in my opinion, especially when you talk about raw ingredient manufacturers from other countries, who we already know are cutting corners and not complying with cGMPs. This now says, ‘Hey, not only that, but we’re not going to be looking over your shoulder anytime soon. So go for it.’ When you’re talking about China? Who has just gone through this horrendous experience? And they haven’t just gone through it; they’re still in it?”
It’s not unlikely to imagine that among raw ingredients suppliers around the globe who have suffered severe economic losses due to the pandemic, there will be some who turn to economic adulteration.
“I think it is fair to be concerned about that,” says Steve Mister, president and CEO of the Council for Responsible Nutrition (Washington, DC). “I think there is an opportunity at this point for there to be mischief, and we would hope that companies would resist that temptation.”
Daniel Fabricant, PhD, president and CEO of the Natural Products Association (Washington, DC), says: “I mean, I think everyone’s gotta be on their toes. FDA’s kind of abandoned their post, and it’s up to the industry now. We have a promise to keep with the American public, and so I think we will. I think our members, the legitimate manufacturers, are going to do just that. They’re going to step up to the plate. This is why we worked on things like SSCI”-the Supplement Safety Compliance Initiative, which sets benchmarked standards across the dietary supplements industry to improve manufacturing quality.
Still, many worry that not all manufacturers can be trusted. Mark LeDoux, chairman and CEO of supplier Natural Alternatives International (Carlsbad, CA), says: “One can always maintain the belief that, under duress, the true character of executives and managers will be on prominent display. That’s my worry. While the majority of companies engaged in the production of supplements are reputable, there remains a significant portion who will maximize their profits in this environment by doing as little as possible in terms of quality oversight.”
Supply Chain Impact: Possible Shortages, Economic Adulteration
Increased economic adulteration is a credible threat due to COVID-19, especially considering that there could be less available supplies of some ingredients due to global restrictions on manufacturing and trade.
During the aforementioned AHPA webcast on March 26, speaker and attorney John Hagan, Jr., a partner at Arnold & Porter LLP (Chicago), said: “It is estimated now that 75% of U.S. companies are having some supply chain disruptions, and so coming up with contingency plans and stress testing are very important.”
During a Q&A portion of the webcast, AHPA president Michael McGuffin said he had read about potential challenges in India, for instance, including potential “disruptions in state-to-state transport. So, some states are closing their borders to trucks coming in from other states, which certain sounds like it will make it difficult to get things to ports in a central state.” He said that while AHPA is currently doing outreach among its members to get more information, “I don’t have any actual on-the-ground knowledge other than that” at this point in time.
In a March 24 interview, CRN’s Mister also mentioned concerns he’s heard about supply chains in India. “The one thing we have started to hear is concerns from some manufacturers who have supply chains in India. Because India is pretty much on a national shelter-in-place ordinance-like what some of our states have done here, but the entire country-it is making it very hard. Even if the facilities are open, transportation to get them to an airport and then fly them out of the country is apparently being slowed down.” Mister said CRN is also conducting outreach among its members to determine which ones might be experiencing supply chain issues.
Given these likely challenges worldwide, there are real risks of impending supply shortages-and of resulting economic adulteration. Take the botanical dietary supplement supply chain. We turned to Mark Blumenthal, founder and executive director of the American Botanical Council (ABC; Austin, TX), and Stefan Gafner, PhD, chief science officer for ABC and technical director of the Botanical Adulterants Prevention Program (BAPP), a joint program between ABC, the American Herbal Pharmacopoeia (AHP; Scotts Valley, CA), and the National Center for Natural Products Research (NCNPR; University, MS). Blumenthal and Gafner shared their concerns.
“We are intensely looking into the issues as well,” they said, “and are especially concerned that some fraudulent suppliers may attempt to take advantage of the shortages to supply low-quality and/or adulterated materials.”
Said Gafner: “I think that responsible dietary supplement manufacturers already have a sufficient ingredient identity testing program in place to ensure that their products are authentic. That’s simply a basic requirement of being a ‘responsible’ manufacturer. However, due to the higher than normal consumer interest in herbal ingredients that have immunomodulatory benefits, as well as those herbs believed to support the respiratory system, there is a risk of adulterants finding their way into herbal ingredients where adulteration is often not expected. In addition, new schemes of adulteration may be cooked up to fool standard authentication tests for those herbs that are currently in high demand.
“Another issue is the qualification of a new vendor in case the usual supply chain is no longer able to deliver the ingredient. While companies often have a backup supplier, this may not be the case for all ingredients. There may be situations when there is a lot of pressure on procurement managers to find new suppliers quickly. However, companies may be better off to have a product out of stock rather than to approve a new supplier without having done a thorough audit, as required by GMPs for supplier qualification.
“In other words, at the end of the day, given what is most likely an inevitable increase in the availability of adulterated ingredients, botanical dietary supplement manufacturers and other buyers are advised to double-down-perhaps even triple-down-on their identity testing protocols.”
Supplement manufacturers might not be able to purchase the all of their ingredients the way they once did. AGG’s Bell says that in some countries, suppliers might “take care of their own people before they start manufacturing for exportation to other countries.”
Bell says the potential supply chain ripples, added to suspended FDA inspections, is alarming. “That is the epitome of the Wild West,” he says, “because we’re going to be dealing with a lot of things. Shortages of some ingredients. I’m hearing news that some factories aren’t making what they used to make. They’re now making what they think people want. So, less of this type of an ingredient; more of stuff that might now go to immune system products. And they can switch that quickly. And so companies over here saying, ‘Oh, well, I’m going to go back to my same three companies to buy my amino acid for sports nutrition’-they may not have the kind of volume that they had, or [their supplier] may not even be making it anymore because they’re moved over to make three other ingredients that they think are going to be important for the next 12-24 months.”
These scenarios leave Bell wondering how the “pressure points” that are likely to emerge could impact the end quality of supplements on the market. For instance, he says, ingredient prices might go up. “If it’s a shortage, potentially the few with the most power are the ones in other countries manufacturing raw ingredients,” he points out. “If you want it, you’re going to have to pay this for it.”
This will cause manufacturers to look for other ways to trim costs. “There’s only a few things you can do,” Bell says. “You could switch to cheaper packaging, but that’s expensive, changing labels and packaging. They’re going to want to keep their costs as low as they can, and that’s going to force contract manufacturers to try to cut corners where they can, and that can be done in a few different ways.” Manufacturers could start using cheaper, lower-quality ingredients, he says. Or they could start “pixie-dusting”-cutting back on the amount of an ingredient in a product.
Due Diligence, Planning Ahead
Companies can take control and plan ahead for these upcoming challenges by doing their due diligence. For instance, companies should expect to exhibit heightened scrutiny when testing incoming ingredients, given that economic adulteration could be more likely. They should also be prepared to make changes quickly if needed, and to have backup plans, not only for ingredients and materials but also for personnel.
During the AHPA webcast, speaker Sean Murray, president, U.S. food testing division, Eurofins, described how his company and its testing labs are focused on planning for redundancy. “You’ve got to be thinking about the fact that a large group of people could be taken out” if employees become ill due to coronavirus and can’t work. You need to think about how to replace those groups of workers in the interim. The same goes for other suppliers the company relies on, including couriers. Backup plans, including cross-training employees, are a key part of preparing ahead of time, “because if you’re trying to make these changes in the midst of a rampant local situation, it’s going to be difficult.” He said: “Have at least one backup…even if it’s just one, it massively improves the reliability of your suppliers of your operation.”
Streamlining supplement formulas is another way to potentially skirt ingredient-supply shake-ups that companies could experience, advises AGG’s Bell.
“I think what companies ought to do is step back and say, ‘Okay, I’ve got 20 ingredients in this sports nutrition product. I could probably take 10 of them out right now without thinking about whether it would affect the efficacy of the product.” Reducing the number ingredients not only could lower a company’s cost of goods; by reducing the number of ingredients, companies also reduce the number of headaches and risks they will encounter in terms of potential ingredient supply or quality problems. “You’ve just reduced the risk factor by several ingredients,” Bell says.
Additional precautions from regulators would also be nice to see. In addition to encouraging companies to participate in the self-regulatory SSCI program, NPA’s Fabricant and NAI’s LeDoux say they wish FDA would use its power to issue import alerts to ports of entry, encouraging them to deny entry to ingredients that aren’t on FDA’s list of ingredients with submitted new dietary ingredient notifications (NDIs)-crucial during this time when foreign inspections are down. “All FDA would have to do is proffer a memo to the ports, and the ports could detain [an ingredient] on import until those companies submitted an NDI notification,” says Fabricant. This would prevent “materials coming in that are knocking off NDIs,” with no data filed with FDA.
LeDoux calls this an “easy solution.” “One easy solution is to close the nation’s borders to all products from anywhere that does not have a recognized NDI AKL (acknowledgement) notification number. That is not a heavy lift for the agency at all and would require a signature on a piece of paper directing the customs and border enforcement component of Homeland Security to offer that protection.”
In the long term, the potential supply chain challenges the dietary supplement industry experiences as a result of the pandemic could have the industry reevaluating where and from whom they source ingredients.
LeDoux predicts that “China is going to lose a lot of their primary manufacturing status in this industry.” He continues: “I think ‘Made in China’ is going to be a long-term problem for many years to come. People are going to be willing to pay more for products that have no exposure to China. The challenge is to reactivate the primary chemical industry that 30 or 40 years ago supplied these vitamins and other compounds to industry.”
Other countries could pick up some of that business. Domestic suppliers will also be taking another look at sources closer to home, he says. “Companies located elsewhere with combinations of educated workforces and industrial policies encouraging investment and growth are going to emerge, whether they are in the USA, Europe, or other parts of the world, and are going to inherit business. Also, I predict many countries will make provisions for investment credits and other incentives to assure that future crises will be addressed by domestic manufacturing versus a reliance on foreign suppliers.”
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