By Todd Harrison, Venable01.26.22
As we begin 2022, we are still “officially” stuck in a pandemic, though the situation on the ground indicates we are likely at the beginning of an endemic. Of course, the SARS-CoV-2 virus may have a different design as it constantly mutates.
The terms “mutate” and “mutation” do not only relate to viruses, but could also apply to our laws, regulations, and public policy—even though that’s not common practice. Rather, when we see changes in these areas, we use words such as “transformative,” “revolutionary,” or simply the “changing times.” Of course, these all essentially mean the same thing.
A mutation or transformation can be good or bad. In the case of SARS-CoV-2, it appears the omicron variant may be less severe than others, though it’s also more contagious. Omicron may lead elected officials to understand that SARS-CoV-2 is not going away, and we will need to learn to manage and live with it at some point.
Lessons to Learn
Can we learn any lessons from nature and a mutating virus? Yes, but only if we are willing to be bold, and as transformative as this particular virus. Thus, as 2022 begins, the pandemic winds down, and the endemic phase begins, we need to ask why are our laws, regulations, and public policies are not transforming enough to prioritize the maintenance of overall health. Instead, we are relying solely on drugs and vaccines to make that difference.
While there are certainly exceptions, it seems that overall health status of an individual and comorbidities like obesity, type 2 diabetes, cardiovascular disease, and similar chronic diseases indicate how well people will cope with a bout of COVID-19.
The interesting issue regarding many of these comorbidities is that they are often preventable. Too many health officials don’t discuss publicly the role of proper nutrition in preventing chronic health conditions. Instead, our government and country prefer to literally have their cake and eat it too.
Unfortunately, these comorbidities are serious and SARS-CoV-2 will exacerbate their lethality. To be clear, I am fully vaccinated and boosted because I believe vaccination is one tool in our toolbox; it is not the only tool. We must use everything at our disposal to fight an unseen enemy that will exploit weaknesses, regardless of vaccination status.
Time to Transform
My point is that it’s time for a change in paradigm—radical, revolutionary, transformative change. Our paradigm is mired in simplistic thinking that a pill can save your life despite chronically unhealthy habits. Indeed, medications may save your life, but at what cost? The more comorbidities you have, the more pills you are taking, and the more your quality of life suffers.
However, as I have said, chronic diseases that bring on these comorbidities can often be avoided through proper nutrition. Yet, our laws, regulations, and the public policy pronouncements from our government avoid this discussion.
We’ve set up rules that we cannot discuss how nutrients or botanicals can help prevent disease, because that would deem them to be drugs. Yet, not one drug on the market except vaccines actually prevents disease—and there are not that many vaccines. Even vaccines only tend to work against stable viruses that do not mutate, as SARS-CoV-2 has and will likely continue to do.
Thus, we are playing whack-a-mole with our vaccine strategy. It is possible that stating what I consider to be obvious will cause some backlash, but it is simply the hard truth. We are playing whack-a-mole with this virus, and probably future viruses, and will continue to do so for the rest of our lives, our children’s lives, and grandchildren’s lives.
However, a sound basis for maintaining health can certainly help mitigate these issues alongside vaccines and therapeutics. These do not have to be mutually exclusive. Rather, they can be inclusive of each other. But we need transformative changes in the laws to achieve that synergy.
Foundations in Nutrition
The first change should be to permit broader promotion of the benefits of nutrients in food and dietary supplements and how they can be transformative to health. Vitamin D may be the most important micronutrient, but we still hear very little about the value of vitamin D to health. Instead, the law punishes commercial enterprises that discuss documented health benefits.
Is vitamin D a panacea? No, but it is certainly an inexpensive way to help people boost their health status. Quercetin—that little known flavonoid—has been shown to have an impact on respiratory health, but if a commercial enterprise talks about that in relation to helping with disease outcomes, or simply helping to prevent more serious outcomes, it can be punished.
Access and Accountability
The issue is not just about claims in general. It is also about continuing to have access to important nutrients such as NAC. For example, I think the law should be changed to allow companies to sue the FDA over warning letters that erroneously state NAC is a drug. Those statements ignore the fact that when NAC is ingested it is metabolized almost completely into cysteine, a necessary amino acid.
Indeed, currently, FDA can allege violations of the law through warning letters and not worry about repercussions if it’s wrong because companies that receive these notices cannot sue the agency. Why not? Warning letters are not considered “final agency action.” Yet, in practicality they are final agency action, because larger e-tailers and retailers will consequently remove perfectly legitimate products from their marketplace, even though the agency may be wrong.
While we’re at it, the preclusion provision for dietary supplements and foods requires an overhaul to permit the marketing of nutrients and dietary ingredients that have a beneficial effect in maintaining health even if higher dose levels of that ingredient are precluded.
Ultimately, SARS-CoV-2 is a gamechanger that requires a radical rethinking of how we look at health and how to achieve the best outcomes. This requires a strategy that not only includes vaccines and therapeutics but also nutrients, dietary ingredients, and phytochemicals that can help prevent serious conditions.
We need our public health agencies to be honest with us regarding lifestyle choices. We cannot continue to eat poorly while ignoring the benefits of nutrition and dietary supplements. Otherwise we will continue to suffer from chronic illnesses like type 2 diabetes, obesity, and cardiovascular disease, because either a virus will accelerate the process, or quality of life will decline as people reach their older years.
SARS-CoV-2 should be a wakeup call for better health, but so far that messaging is not being heard among the public. Let’s be bold in 2022 and push the fight forward to truly integrate the best of all approaches toward healthy living into the fabric of our public policies, laws, and regulations.
Todd Harrison is partner with Venable, which is located in Washington, D.C. He advises food and drug companies on a variety of FDA and FTC matters, with an emphasis on dietary supplement, functional food, biotech, legislative, adulteration, labeling and advertising issues. He can be reached at 575 7th St. NW, Washington, D.C. 20004, Tel: 202-344-4724; E-mail: taharrison@venable.com.
The terms “mutate” and “mutation” do not only relate to viruses, but could also apply to our laws, regulations, and public policy—even though that’s not common practice. Rather, when we see changes in these areas, we use words such as “transformative,” “revolutionary,” or simply the “changing times.” Of course, these all essentially mean the same thing.
A mutation or transformation can be good or bad. In the case of SARS-CoV-2, it appears the omicron variant may be less severe than others, though it’s also more contagious. Omicron may lead elected officials to understand that SARS-CoV-2 is not going away, and we will need to learn to manage and live with it at some point.
Lessons to Learn
Can we learn any lessons from nature and a mutating virus? Yes, but only if we are willing to be bold, and as transformative as this particular virus. Thus, as 2022 begins, the pandemic winds down, and the endemic phase begins, we need to ask why are our laws, regulations, and public policies are not transforming enough to prioritize the maintenance of overall health. Instead, we are relying solely on drugs and vaccines to make that difference.
While there are certainly exceptions, it seems that overall health status of an individual and comorbidities like obesity, type 2 diabetes, cardiovascular disease, and similar chronic diseases indicate how well people will cope with a bout of COVID-19.
The interesting issue regarding many of these comorbidities is that they are often preventable. Too many health officials don’t discuss publicly the role of proper nutrition in preventing chronic health conditions. Instead, our government and country prefer to literally have their cake and eat it too.
Unfortunately, these comorbidities are serious and SARS-CoV-2 will exacerbate their lethality. To be clear, I am fully vaccinated and boosted because I believe vaccination is one tool in our toolbox; it is not the only tool. We must use everything at our disposal to fight an unseen enemy that will exploit weaknesses, regardless of vaccination status.
Time to Transform
My point is that it’s time for a change in paradigm—radical, revolutionary, transformative change. Our paradigm is mired in simplistic thinking that a pill can save your life despite chronically unhealthy habits. Indeed, medications may save your life, but at what cost? The more comorbidities you have, the more pills you are taking, and the more your quality of life suffers.
However, as I have said, chronic diseases that bring on these comorbidities can often be avoided through proper nutrition. Yet, our laws, regulations, and the public policy pronouncements from our government avoid this discussion.
We’ve set up rules that we cannot discuss how nutrients or botanicals can help prevent disease, because that would deem them to be drugs. Yet, not one drug on the market except vaccines actually prevents disease—and there are not that many vaccines. Even vaccines only tend to work against stable viruses that do not mutate, as SARS-CoV-2 has and will likely continue to do.
Thus, we are playing whack-a-mole with our vaccine strategy. It is possible that stating what I consider to be obvious will cause some backlash, but it is simply the hard truth. We are playing whack-a-mole with this virus, and probably future viruses, and will continue to do so for the rest of our lives, our children’s lives, and grandchildren’s lives.
However, a sound basis for maintaining health can certainly help mitigate these issues alongside vaccines and therapeutics. These do not have to be mutually exclusive. Rather, they can be inclusive of each other. But we need transformative changes in the laws to achieve that synergy.
Foundations in Nutrition
The first change should be to permit broader promotion of the benefits of nutrients in food and dietary supplements and how they can be transformative to health. Vitamin D may be the most important micronutrient, but we still hear very little about the value of vitamin D to health. Instead, the law punishes commercial enterprises that discuss documented health benefits.
Is vitamin D a panacea? No, but it is certainly an inexpensive way to help people boost their health status. Quercetin—that little known flavonoid—has been shown to have an impact on respiratory health, but if a commercial enterprise talks about that in relation to helping with disease outcomes, or simply helping to prevent more serious outcomes, it can be punished.
Access and Accountability
The issue is not just about claims in general. It is also about continuing to have access to important nutrients such as NAC. For example, I think the law should be changed to allow companies to sue the FDA over warning letters that erroneously state NAC is a drug. Those statements ignore the fact that when NAC is ingested it is metabolized almost completely into cysteine, a necessary amino acid.
Indeed, currently, FDA can allege violations of the law through warning letters and not worry about repercussions if it’s wrong because companies that receive these notices cannot sue the agency. Why not? Warning letters are not considered “final agency action.” Yet, in practicality they are final agency action, because larger e-tailers and retailers will consequently remove perfectly legitimate products from their marketplace, even though the agency may be wrong.
While we’re at it, the preclusion provision for dietary supplements and foods requires an overhaul to permit the marketing of nutrients and dietary ingredients that have a beneficial effect in maintaining health even if higher dose levels of that ingredient are precluded.
Ultimately, SARS-CoV-2 is a gamechanger that requires a radical rethinking of how we look at health and how to achieve the best outcomes. This requires a strategy that not only includes vaccines and therapeutics but also nutrients, dietary ingredients, and phytochemicals that can help prevent serious conditions.
We need our public health agencies to be honest with us regarding lifestyle choices. We cannot continue to eat poorly while ignoring the benefits of nutrition and dietary supplements. Otherwise we will continue to suffer from chronic illnesses like type 2 diabetes, obesity, and cardiovascular disease, because either a virus will accelerate the process, or quality of life will decline as people reach their older years.
SARS-CoV-2 should be a wakeup call for better health, but so far that messaging is not being heard among the public. Let’s be bold in 2022 and push the fight forward to truly integrate the best of all approaches toward healthy living into the fabric of our public policies, laws, and regulations.
Todd Harrison is partner with Venable, which is located in Washington, D.C. He advises food and drug companies on a variety of FDA and FTC matters, with an emphasis on dietary supplement, functional food, biotech, legislative, adulteration, labeling and advertising issues. He can be reached at 575 7th St. NW, Washington, D.C. 20004, Tel: 202-344-4724; E-mail: taharrison@venable.com.
