Todd Harrison, Venable11.02.15
The past year has seen a series of ups and downs for the nutraceuticals industry, and I’ve discussed many of these issues in my previous columns. The ups are demonstrated by the string of rebukes to the FTC’s belief that it can simply substitute its expert’s beliefs for those who disagree. The downs of the past year are related to one critical issue the industry has consistently ignored: supply chain integrity.
I have written about this important topic before, and have come under attack for my views on our self-inflicted wounds. Even on the claims side, many have criticized my desire to revisit the Dietary Supplement Health and Education Act (DSHEA) to allow more than simple structure/function claims. Many people have feared touching the holy grail of 1994. However, there finally appears to be a movement and a desire to begin addressing the shortcomings of DSHEA as well as supply chain integrity.
Sure enough, there are those in the industry who prefer to keep the status quo at the expense of progress, as it’s easier to be reactionary than innovative—a position I find a bit ironic considering this industry is supposed to be about innovation.
Dietary supplements are intended to keep people healthy and prevent a slow demise into a chronic state of being unhealthy, which eventually leads to the chronic disease that is sapping so much of our financial resources in this country. Sure, disease is big business, but so is maintaining overall health and well-being. The difference is that insurance and government take care of the former while the individual takes care of the latter. In the long-term though, it is better for the health of our country if we stay healthy instead of slipping into disease.
Challenging the Paradigm
The dietary supplement and functional food industries provide the best opportunity to promote wellness, but it requires us to stop being reactionary and instead challenge the existing paradigm. We need to start pushing back and challenge what is really a “disease” and what is not. Simply because a drug is approved for a particular purpose does not mean that condition is a disease. Yet that is exactly what we have allowed to happen because of an unwillingness to challenge FDA on simple concepts, such as “inflammation,” which is happening right now in your body as you read this article, or minor aches and pains associated with joints.
As we age our joints get sore; it is a part of life. Yes, some will define this as the early stages of osteoarthritis, but such a narrow view assumes that we will go down the road of developing a more chronic disease. The fact is that we can help reduce inflammation and slow the progression of osteoarthritis without drugs, because in reality the start of osteoarthritis is also a normal part of aging, as is menopause and—I dare say—benign prostatic hyperplasia (BPH). Yes, these normal parts of aging may develop into a chronic disease at some point, but at the beginning they are a natural part of the aging process and we need to start making this clear and stand up for this position.
FTC Claims Battles
This leads to the one bright spot this year. Companies are actually fighting the FTC in court. To this end, the FTC has not fared very well. Indeed, it has lost more than it has won, and the one case it purportedly won was actually a loss, because the court clearly stated that its decision would likely have been different if the claims in question were structure/function claims.
The courts in POM, Basic Research and Bayer have actually started to look at the standard of “competent and reliable” and what it actually requires, which is not a clinical study on the finished product—nor necessarily even ingredient studies—but what experts in the relevant field would believe based on “tests, analyses, research, studies, or other evidence.”
In other words, the FTC cannot simply state “our expert disagrees, so we win.” In fact, that has always been its argument and the courts have clearly rejected it this past year. Am I advocating against doing clinical studies? No, but there is also no incentive to do the research because the claims are just too narrow. That is why I continue to believe that if a company conducts a clinical study on its finished product, it should be able to make the claim—even if the claim is arguably a disease claim (e.g., “alleviates joint pain and inflammation”).
This would require either FDA to think outside the box, or more likely, legislation. However, the industry remains concerned that such legislation will degrade DSHEA. I would argue the opposite; it would strengthen DSHEA and would counteract the mass media belief that we are unregulated and marketing sham products.
NY AG & Creating Credibility
Of course, our recent issues with the New York Attorney General have not helped our credibility overall. I have had many conversations regarding the NY AG, supply chain integrity, and the Food Safety Modernization Act (FSMA) with my colleagues in recent months. I have been privately chastised for my willingness to air the industry’s dirty laundry, which some claim isn’t helpful. I disagree that it has not been helpful. After 6 months of whining the industry is actually starting to listen and understand that it needs to clean up its supply chain issues.
Indeed, if we cannot get this one area right, why should regulators believe anything we say? If we cannot deliver on the simple promise of providing quality products to the consumers that rely on our products, then why should the regulators believe what we say? The fact is the majority of this industry is made up of good players that provide quality products; it is the minority that hurts the industry. However, we simply make it easy for regulators to doubt our intention.
I represent the National Animal Supplement Council, which has a supply chain integrity program that puts the human side to shame. If such a small part of the industry can get it right, why can’t the human side?
Instead of crying over spilled milk, the message should be a simple and positive: that while we disagree that DNA testing is the holy grail, we are committed to strong cGMPs, not only for finished products but for ingredient manufacturers and suppliers as well. We believe the majority of ingredient manufacturers and suppliers are honest individuals, but to provide transparency we are adopting the following supply chain integrity program. I do not want to hear that this is an anti-trust violation as suggested by some, because it is not.
Easy Targets & Adverse Events
Now, we have a new cause célèbre—Serious Adverse Event Reports (SAERs) are a much larger issue based on a survey of approximately 3,300 reports, which a study published in the New England Journal of Medicine extrapolated to more than 23,000 a year. Again, because we are not trusted as an industry with the simplest of issues such as supply chain integrity, we become an easy target for this silliness.
The fact is the legislation is written in a manner that requires an SAER to be reported regardless of whether there is an actual relationship between the SAER and the dietary supplement. Why? Because the law states that an SAER must be reported if the consumer believes there is an association, not whether there is actually an association.
However, the issue does not end there because FDA itself has distorted the purpose of the law. For instance, FDA sent a warning letter to one company stating an emergency room visit was an SAER related to the product (this one was an OTC product), even though the visit was wholly unrelated to the product in question. How do we know this? Simple, the attending physician sent the person home with Tamiflu. The law and FDA’s enforcement of the law distort the reality of the situation, and has very little to do with whether or not there was an actual causal connection between the SAER and the supplement. However, when you fail to get the small things correct, it is hard to convince regulators and the mass media we are right about the bigger issues.
Todd Harrison
Venable
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.
I have written about this important topic before, and have come under attack for my views on our self-inflicted wounds. Even on the claims side, many have criticized my desire to revisit the Dietary Supplement Health and Education Act (DSHEA) to allow more than simple structure/function claims. Many people have feared touching the holy grail of 1994. However, there finally appears to be a movement and a desire to begin addressing the shortcomings of DSHEA as well as supply chain integrity.
Sure enough, there are those in the industry who prefer to keep the status quo at the expense of progress, as it’s easier to be reactionary than innovative—a position I find a bit ironic considering this industry is supposed to be about innovation.
Dietary supplements are intended to keep people healthy and prevent a slow demise into a chronic state of being unhealthy, which eventually leads to the chronic disease that is sapping so much of our financial resources in this country. Sure, disease is big business, but so is maintaining overall health and well-being. The difference is that insurance and government take care of the former while the individual takes care of the latter. In the long-term though, it is better for the health of our country if we stay healthy instead of slipping into disease.
Challenging the Paradigm
The dietary supplement and functional food industries provide the best opportunity to promote wellness, but it requires us to stop being reactionary and instead challenge the existing paradigm. We need to start pushing back and challenge what is really a “disease” and what is not. Simply because a drug is approved for a particular purpose does not mean that condition is a disease. Yet that is exactly what we have allowed to happen because of an unwillingness to challenge FDA on simple concepts, such as “inflammation,” which is happening right now in your body as you read this article, or minor aches and pains associated with joints.
As we age our joints get sore; it is a part of life. Yes, some will define this as the early stages of osteoarthritis, but such a narrow view assumes that we will go down the road of developing a more chronic disease. The fact is that we can help reduce inflammation and slow the progression of osteoarthritis without drugs, because in reality the start of osteoarthritis is also a normal part of aging, as is menopause and—I dare say—benign prostatic hyperplasia (BPH). Yes, these normal parts of aging may develop into a chronic disease at some point, but at the beginning they are a natural part of the aging process and we need to start making this clear and stand up for this position.
FTC Claims Battles
This leads to the one bright spot this year. Companies are actually fighting the FTC in court. To this end, the FTC has not fared very well. Indeed, it has lost more than it has won, and the one case it purportedly won was actually a loss, because the court clearly stated that its decision would likely have been different if the claims in question were structure/function claims.
The courts in POM, Basic Research and Bayer have actually started to look at the standard of “competent and reliable” and what it actually requires, which is not a clinical study on the finished product—nor necessarily even ingredient studies—but what experts in the relevant field would believe based on “tests, analyses, research, studies, or other evidence.”
In other words, the FTC cannot simply state “our expert disagrees, so we win.” In fact, that has always been its argument and the courts have clearly rejected it this past year. Am I advocating against doing clinical studies? No, but there is also no incentive to do the research because the claims are just too narrow. That is why I continue to believe that if a company conducts a clinical study on its finished product, it should be able to make the claim—even if the claim is arguably a disease claim (e.g., “alleviates joint pain and inflammation”).
This would require either FDA to think outside the box, or more likely, legislation. However, the industry remains concerned that such legislation will degrade DSHEA. I would argue the opposite; it would strengthen DSHEA and would counteract the mass media belief that we are unregulated and marketing sham products.
NY AG & Creating Credibility
Of course, our recent issues with the New York Attorney General have not helped our credibility overall. I have had many conversations regarding the NY AG, supply chain integrity, and the Food Safety Modernization Act (FSMA) with my colleagues in recent months. I have been privately chastised for my willingness to air the industry’s dirty laundry, which some claim isn’t helpful. I disagree that it has not been helpful. After 6 months of whining the industry is actually starting to listen and understand that it needs to clean up its supply chain issues.
Indeed, if we cannot get this one area right, why should regulators believe anything we say? If we cannot deliver on the simple promise of providing quality products to the consumers that rely on our products, then why should the regulators believe what we say? The fact is the majority of this industry is made up of good players that provide quality products; it is the minority that hurts the industry. However, we simply make it easy for regulators to doubt our intention.
I represent the National Animal Supplement Council, which has a supply chain integrity program that puts the human side to shame. If such a small part of the industry can get it right, why can’t the human side?
Instead of crying over spilled milk, the message should be a simple and positive: that while we disagree that DNA testing is the holy grail, we are committed to strong cGMPs, not only for finished products but for ingredient manufacturers and suppliers as well. We believe the majority of ingredient manufacturers and suppliers are honest individuals, but to provide transparency we are adopting the following supply chain integrity program. I do not want to hear that this is an anti-trust violation as suggested by some, because it is not.
Easy Targets & Adverse Events
Now, we have a new cause célèbre—Serious Adverse Event Reports (SAERs) are a much larger issue based on a survey of approximately 3,300 reports, which a study published in the New England Journal of Medicine extrapolated to more than 23,000 a year. Again, because we are not trusted as an industry with the simplest of issues such as supply chain integrity, we become an easy target for this silliness.
The fact is the legislation is written in a manner that requires an SAER to be reported regardless of whether there is an actual relationship between the SAER and the dietary supplement. Why? Because the law states that an SAER must be reported if the consumer believes there is an association, not whether there is actually an association.
However, the issue does not end there because FDA itself has distorted the purpose of the law. For instance, FDA sent a warning letter to one company stating an emergency room visit was an SAER related to the product (this one was an OTC product), even though the visit was wholly unrelated to the product in question. How do we know this? Simple, the attending physician sent the person home with Tamiflu. The law and FDA’s enforcement of the law distort the reality of the situation, and has very little to do with whether or not there was an actual causal connection between the SAER and the supplement. However, when you fail to get the small things correct, it is hard to convince regulators and the mass media we are right about the bigger issues.
Todd Harrison
Venable
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.
