While the dietary supplement industry continues to adapt, here’s a look at how protocol may be changing for manufacturing, research, marketing and more.
There is a broadening consensus that despite the nutraceutical industry’s resilience in this crisis, there will be a wide range of sustained changes as a result of the pandemic.
By Mike Montemarano, Associate Editor
June 08, 2020
While many regions of the globe still appear to be facing many more days of isolation, fiscal downturn, and loss of life as a result of the COVID-19 pandemic, the industries fueling every segment of the economy have been mulling what kinds of permanent, fundamental changes will be sustained.
Many within the dietary supplements industry are bracing for lasting shake-ups to the way that marketing, research, manufacturing, and distribution is conducted, and there is a great deal of speculation on how this global pandemic will influence where natural products and ingredients come from, how they can be made safely, what kind of consumer landscape will exist in the future, what types of regulatory changes will be felt the most, and how this crisis will reshape the clinical trials vital to medical and nutritional products.
The concept of supply chain globalization is not, by any means, limited to the dietary supplements industry. Like virtually any other manufacturing-dependent industry, dietary supplement companies have had a heavy reliance upon suppliers and manufacturers from overseas due to the advantages that have long been provided. This crisis demonstrated from the start the sheer vulnerability that contemporary supply chains have to a global pandemic, due to bottlenecking and a patchwork of regional lockdowns, manufacturing plant closures, and restrictive shipping price spikes; whereas more localized operations naturally saw a greater amount of resilience in the face of this threat.
“We will source raw materials and produce more goods domestically,” said Mark LeDoux, chairman of the Natural Products Association, and founder, CEO, and chairman of Natural Alternatives International, Inc. and CarnoSyn Brands. “One of the things that the pandemic exposed is how reliant we are on other countries for both raw materials and production. Many countries including the USA are starting to think much harder about the requirements around manufacturing and sourcing within their own borders. Companies who have long sourced raw materials and production overseas for savings are now realizing the importance of being able to do this domestically.”
In the wake of the U.S. Food and Drug Administration’s suspension of domestic inspections, LeDoux said that self-policing within the industry can only go up as a result of the industry’s dealing with FDA’s loosened inspection policies that came about as a result of the health hazard. Food safety authorities have scaled back auditing practices across the globe to a fraction of the frequency seen in pre-COVID days, and will likely return to these practices very slowly, using remote methods predominantly at first.
“As we have seen, the FDA can only do so much,” LeDoux said. “With everyone being extra cautious in the wake of the pandemic, there has never been a better time for responsible industry folks to join forces with the FDA and help take the burden off of them to ensure compliance. For example, retailers could tell manufacturers ‘you either submit your process to SSCI Supplement Safety Compliance initiative or you won’t be sold in our stores.’ Retailers like Walmart and GNC are already having these discussions. Our industry needs to step up and assert our credibility by helping to maintain the integrity of our products and raw materials via enforcement of responsible and safe business practices.”
He believes that this will apply across the board, even among products that have had a history of region-specific agriculture, such as many of the herbs and botanicals long-sourced in natural locations.
“There’s some effort by industry leaders including myself speaking to a task force being headed by Peter Navarro at the White House to look for creative ways to facilitate a repatriation of a lot of these capabilities,” LeDoux said. “It looks like it will take a potential combination of tariffs, tax breaks, and accelerated capital expenditures, in order to reposition the supply chain more domestically. I think there’s also a willingness among consumers to buy products sourced and manufactured in the United States. I don’t think there’s much of a pushback coming due to a disparity in pricing so I think this is something we’ll see happening fairly soon, so long as U.S. manufacturers are able to have a level playing field.”
Gary Smith, vice president of food safety for FoodChain ID, recently discussed in a company-hosted webinar that the disruptions to natural products supply chains are likely to continue being experienced, and, without consistent, long-term precautions being taken by manufacturers, adulteration within these supply chains may see a rise due to the opportunities for it supply gaps provide.
“We’ve seen major supply chain disruptions already. When India shut down exports it had a huge impact on the spice market,” Smith said. “Companies are scrambling to look for new countries of origin, and to be able to vet suppliers, you need tools to be able to do that. Adulteration will continue to be an issue moving forward, and unfortunately, this current crisis will be exploited by unscrupulous suppliers out there. They will have opportunities to fill in gaps with substituted or adulterated materials to take advantage of the companies scrambling to find suppliers, who might not scrutinize things as carefully as before.”
“Logically, it makes sense that this would be the case,” LeDoux said. “The FDA recently announced that they’re suspending foreign inspections of manufacturing facilities, and if you don’t have an inspector looking over your shoulder things could happen. That’s not to say that companies in North America wouldn’t catch those problems, but there’s a higher risk of a product entering commerce that doesn’t meet all the requirements of a routine GMP analysis.”
LeDoux added that freight is a time-consuming process even under the best circumstances, and that virtually anywhere in North America would be more suited to strategic supply chain planning in response to this crisis. One potential hindrance to a quick domestication of the U.S. supplements supply chain may be some discrepancies in NDI enforcement between companies that have gone through FDA’s NDI applications, versus companies with a propensity to incorporate NDIs into their products that mimic the original formulations, claiming that these NDIs are identical to those already approved by FDA without going through the same approvals process.
“A lot of companies that have gone through the NDI process find themselves competing with foreign entities that have an NDI which have not provided FDA with analysis, safety data, or toxicology for their ingredients,” LeDoux said. “I would expect the agency to step up in the not-too-distant future and do things such as import alerts to help preserve the integrity of domestic products in the marketplace.”
Last year, the Council for Responsible Nutrition, Consumer Healthcare Products Association, and the United Natural Products Alliance requested that FDA establish an NDI master file, which would essentially allow companies to submit confidential information ahead of an NDI notification to a master file modeled after the U.S. Drug Master File, which provides a level of IP protection through a framework in which they can prosecute companies that ignore or do not properly use the framework.
“I think the time for talking is over,” LeDoux continued. “Products are coming in off the backs of companies that already secured acknowledgement that these ingredients are safe, so how is it that other companies from other countries can just import a cheaper alternative without going through that process, because it is technically an adulterated compound. So, the FDA needs to up its game to deal with products that are trying to mimic others that have already gone through this sort of very intense scrutiny.”
FoodChain ID, which was the first company administering non-GMO project certification, is among the third-party verification companies offering food and supplements manufacturers tools to vet new suppliers in advance of receiving their products.
The reality has dawned for those working in the supply chain and manufacturing realm that all pandemic safety plans implemented since the global outbreak of COVID-19, including increased sanitation, changes to the production floor, adjustments to scheduling and staffing, consistent employee screenings and contact tracing, and how to control on-site visitors, will remain best practices for what might be multiple years to come, as highlighted in the same presentation by Derek Wiles, operations director for Belazu, a food and ingredients manufacturer based in the U.K. Wiles gave a bird’s eye view of what manufacturing should ideally look like as manufacturing workers continue to report to their sites with the hanging threat of a deadly respiratory illness.
Some sectors of the manufacturing industry, such as meat packing plants which involve many unavoidable high-contact scenarios, have proven to be especially problematic, with devastating outbreaks in which dozens or hundreds of workers at a time have been infected in site-specific outbreaks. In most regions of the globe, regulatory agencies such as OSHA and the CDC in the U.S., and WHO and Global Food Safety Initiative have put out COVID-19 specific recommendations, but not requirements, which manufacturers have chosen to incorporate into their work spaces to varying extents.
Wiles said it is likely Belazu will be consistently upholding and adapting its policies, shaped largely by a combination of government recommendations and advice from external consulting teams, for years to come, and will continue to have workers dedicated to specific roles in an incident team, accounting for and monitoring issues specific to health and safety, internal and external communications, supply chains, and legal matters.
“Pandemic crisis management is far more complex than standard crisis management,” Wiles said, in that “there are many more human factors than any other types of crises.”
Wiles said that a rule of thumb he believes manufacturers are following is to expect sustained workforce reductions of around 35% until the pandemic runs its course. He provided a glimpse into the current daily operations of the 54,000 square foot manufacturing space and 15,000 square foot dispatch site he oversees.
There are obvious but necessary reminders throughout the site to ensure that workers maintain a two-meter bubble of personal space wherever possible, through physical barriers, signage, and markings on the floor, and face-to-face work is avoided at all costs in favor of working side-by-side on assembly lines, the speeds of which have been reduced to make up for staff limitations. Shifts and breaks have been staggered as one means of avoiding transitory contact, and the company has converted all of its stairways and corridors into one-way use.
Pandemic plans are also only intact to the extent to which they are followed by outside contractors who enter the site for essential purposes, and, as such, it is a priority for manufacturers to ensure that these contractors are fully inducted into the site-specific rules.
Constant and transparent communication, and ensuring the ongoing well-being of workers putting themselves at risk, will continue to be a much more acute need in order to ensure manufacturing work forces remain intact both physically and mentally. Regular updates, and a two-way line of communication between workers and the incident response team could prove crucial to holding the line in safety efforts, especially with percolating, widespread industry concerns about overall well-being, mental health, and morale.
“We have regular incident team meetings throughout the week, and we hold briefs once a week with all of our workers,” Wiles said. “As said before, there are a lot of human factors at play, and even in normal times, they can be hidden, so you have to be on top of mental health and well-being. We contact those working from home daily, and cover certain questions. We have a daily agenda of events for all site workers, with WhatsApp groups, banter sessions, and support calls with mental health first aiders. We also send a weekly mental health newsletter to all employees.”
One major, industry-wide shift that those leading the way consider to be part of any pandemic response plan worth its salt is to provide every frontline worker with paid sick leave, as punitive measures will only result in symptomatic workers having reservations about staying home, which could put entire operations at risk.
Naturally, the amount of global government spending on national health agencies’ and universities’ pursuits to find any possible treatment or vaccine to COVID-19 has superseded that spent on any other condition. Widespread analyses suggest hundreds of experimental human clinical trials registered with the federal government have been brought to a halt in favor of finding any and all cures, preventions, and treatments to COVID-19.
This cascade of efforts and resources will be a major interruption to medical, pharmaceutical, and nutritional experiments conducted on humans for the foreseeable future, experts in both Western and adjunctive medicine warn.
These suspensions, which will last for an unknown period of time, will cut off the lifeblood for innovations on many new products which were slated for studies evaluating their efficacy in virtually any non-coronavirus condition, with a few very critical exceptions. Shutdowns are occurring on a case-by-case basis as researchers, including those in enterprises centered around grave medical conditions, attempt to weigh the benefits patients will see as a result of the trials against the risk that these patients expose themselves to the virus. The ethical conundrum is more severe for researchers, and more difficult to live through for patients with especially adverse or life-threatening conditions who are currently hospitalized and have been awaiting admission into a clinical trial for long periods of time.
In trials that began in a pre-COVID world that continue to go on, delayed or less-frequent in-person evaluations represent a major deviation in research protocol. Where telemedicine or remote administration of experimental products is possible, researchers still must take into account the limitations that these circumstances provide. Another logistical factor for researchers to consider will be the actual health impacts that do occur independently of changed protocols. Due to lockdowns in place, people are moving and socializing less, and prolonged isolation is known to be detrimental to many aspects of mental and physical health. These adverse effects are certainly a deviation from the norm for cohorts whose day-to-day behaviors have been radically upended after part of a trial was complete. Obviously, researchers must also brace for the possibility that one or more of their trial patients may contract COVID-19 as well.
The bottom line is that COVID-19 will serve as a detriment to clinical research that is occurring, and what is known about how long this impact might last is as clear as how long it might take for a cascade of breakthrough COVID-19 trials to come to a close with fruitful results.
Research experts have speculated there is a silver lining to what is happening, and project that, globally, the scientific substantiation that is reached in clinical trials, and what governing bodies do with this research, will become digitized and more globalized in the name of efficiency.
“So much work has been done in other countries such as Canada, Australia, and the EU to study the health benefits of certain ingredients and products,” LeDoux said. “Why can’t we use the research that already exists to inform consumers so they make choices that will impact their health and well-being? Congress should instruct the FDA to accept guidelines from other countries versus expending scarce resources to confirm what has already been studied and verified in other countries. We need to take a more global approach and recognize the work that has already been done, adopt those health claims, and provide consumers access to that information.”
LeDoux remains optimistic that more robust studies will be able to come online by the time fall rolls around, and that the medical community by and large will be more prepared for a potential second wave projected by some researchers.
“Not only the dietary supplement industry but the medical industry also has a bunch of products they’d like to engage clinically to identify efficacy for potential uses and outcomes in a host of illnesses, but hospitals are basically shut down to anything other than COVID issues, and research is certainly impeded at this time,” LeDoux said. “I think it might last at this level for the next two or three months but I don’t think it’ll limit the capacity after, say, September before we emerge with some more robust studies. At some point in time this will pass because, if you’re able to reduce the R factor by more than one you’ve got it by the throat.”
It’s no secret that a wide variety of dietary supplements historically known as immune-boosters have seen explosive sales growth in recent months as a result of COVID-19. With that in mind, the supplements industry has, by and large, been very wary of the ways in which companies market these health benefits as a result of the regulatory and public scrutiny being placed on the industry due to the virus, and the fact that no substantial evidence exists supporting any one supplement’s possible impact on COVID-19 outcomes.
While bad actors have certainly generated plenty of media attention, so too has the medical community in its heightened focus on nutrition in the wake of this pandemic, especially in comparison to other public health crises, LeDoux said.
“It’s fascinating to look at how media has shifted their discussion about certain nutrients,” he said. “Medical doctors have been sharing substantial data indicating that vitamin D levels are a good indicator of the severity of this illness or not. Doctors have been talking about the capacity zinc has in reducing viral load replication in the human body.”
There is still an onus on companies to not only market responsibly, but to ensure that the products consumers receive are in fact providing key ingredients at effective levels.
“It’s really positive, and I expect a lot more attention in this area until there is a magic bullet that comes out to eradicate this virus, and the next virus, and the next virus. It will be important to maximize the level of immune function against very significant, deleterious outcomes in all diseases. But, I think you’d have to be a moron to say any dietary supplement would counteract COVID-19. There are a few small enterprises out there bottling up a few thousand of something and putting it on Amazon to make a killing and the FDA has had its hands full just chasing that down,” LeDoux said.
“It’s really just a function of following the rules, they’re there for a good reason. Don’t over-promise, don’t under-deliver. A lot of companies are doing that well,” LeDoux continued. “The other reality is that there are sub-potent products available on the Internet and companies think they can get away with it.”
With or without a change in marketing efforts, consumers are clamoring for the classic vitamins, minerals, botanicals, and fungal products understood to have an impact on immune function. Most companies are extremely hesitant to discuss any speculation, or preliminary COVID-19 related research that is going on due to the many watchdogs ready to report less-than-immaculate messaging which might be interpreted as a “cure, prevention, or treatment,” to a deadly virus first introduced to a human immune system a few months ago.
However, a number of pre-existing conditions not related to viral immunity but still known to have adverse effects on health outcomes in the current situation might be clear to take off, as they do have scientific substantiation. As far as the boom in sales suggests, a wide host of natural ingredients are known to support stress, cardiovascular health, weight management, sleep, blood pressure, and more are coming to mind in consumers looking to prepare themselves either by mitigating known risk factors or finding nutritional solutions to the health issues faced by living in confinement. It’s more than likely that these concerns will pan out in the overall diets of consumers, and not just in the dietary supplements they may or may not choose to purchase. The link between mortality rates and pre-existing conditions will likely inform consumer behavior, as people try to become more proactive in being as healthy as possible to prepare for health vulnerability in the future.
Adding to the regulatory burden is apparent mounting pressure coming from the consumer front, in which those surveyed suggest that brands can make or break themselves based on their conduct during the ongoing crisis. In a survey conducted as part of a 4A’s webinar by the consumer research company Suzy, 71% of U.S. consumers said that if during the pandemic they “perceive a brand putting profit over people, they will lose trust in that brand forever,” which could have huge implications for the ways in which businesses conduct themselves in a health emergency this severe. A great deal of media and consumer attention has been given to the handful of companies accused of making egregious health-related claims about COVID-19, highlighting that people are becoming more scrutinous and skeptical of natural remedies at this time, and these heightened tendencies may very well last for an indefinite period of time, as generations living in a post-COVID world become increasingly savvier at navigating information on nutrition.
Another messaging requirement being hammered into companies’ lexicons by virtually every consumer and market research firm is the need to incorporate empathy and value into consumer messaging.
“Consumers will want brands to demonstrate that they have the best interests of the individual and wider society at heart and are not just driven by the desire for profit maximization,” FMCG Gurus said in a recent report. “Consumers are looking to step back from the daily negative news and re-prioritize what is important to them, exacerbated by issues such as not being able to see family and loved ones. As a result of this, consumers are becoming more appreciative of things that previously less consideration was given to, wanting brands that reflect this new outlook on life and that help maximize personal connections once restrictions on movement are loosened.”
Source: Nutraceuticals World
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