Todd Harrison, Venable01.05.16
As I indicated in my previous column, “Challenging the Status Quo & Addressing Our Own Shortcomings” (November), 2015 was a difficult year for the dietary supplement industry. We continued to see an uptick in consumer class actions while federal and state governments stepped up their enforcement efforts. I have always been very blunt in saying that many of the issues the industry faces are self-inflicted.
When the Dietary Supplement Health and Education Act (DSHEA) was passed back in 1994, we did not yet have the Internet, and outside of multivitamins the dietary supplement industry was still very much a nascent market that felt like it was under siege by regulators. DSHEA provided a much-needed reprieve from the constant barrage of unjustified enforcement actions. It created a safe haven that allowed the market to grow and flourish, but there was a dark side lurking underneath DSHEA that would arise at some point and cause another siege.
A Problematic Recipe
Specifically, DSHEA created a regulatory system that allowed anyone into the market regardless of intentions. It created a system of claims that do not allow for truthful communication about the purpose of products. Rather, DSHEA created a construct of absurd terms such as “joint comfort” and “already in the normal range.” It allowed lawyers—yes lawyers—to create legal constructs such as the two-click rule, and to develop reasonable legal arguments regarding why a new dietary ingredient notification was not required.
Added to the mix was a regulatory agency that decided not to enforce important provisions of DSHEA for more than a decade (probably closer to two decades), and another regulatory agency deciding that if the primary agency is not going to enforce the law then it would—based on its own internal biases against anything that does not fit squarely into its paradigm under the guise “we must protect consumers from unscrupulous peddlers of snake oil.”
This recipe created the perfect storm, and set us up for one of the most turbulent years the industry has faced in more than two decades. Law and policy have been turned on their heads. Reputable companies found themselves in the crosshairs of state attorneys general, contempt proceedings were brought against a company that was making rather simple digestive health claims (fortunately the court found that the FTC could not meet its burden), and FDA increased enforcement actions and warning letters.
All of this culminated in a show of force when the Department of Justice was joined at a press conference by FDA, FTC, the U.S. Postal Inspection Service, the Department of Defense and the U.S. Anti-Doping Agency to level one charge after another against the industry in one of the greatest shows of chest pounding that I have seen in my 53 years of life. One would think the industry was infiltrated by a terrorist group that threatened our very national security. Make no mistake about the purpose of that press conference; it was not to mention its recent actions, but to send a not-too-subtle message to the industry to get your house in order, or else.
A Coherent Regulatory System
What is the industry to do after a year in which it saw public confidence erode and the skepticism of government increase? Many measures have been suggested, ranging from voluntary company and product registration to compulsory registration. While I applaud these efforts, the proposals are merely cosmetic in nature and do not address issues of supply chain integrity, claims and new dietary ingredients. They will do little to stem the erosion of public confidence in the industry.
While I am not a fan of government regulation or intervention, it is time to develop a more coherent regulatory system. This system should be more consistent with how the general public uses dietary supplements and provide incentives to companies to 1) take the necessary steps to ensure that consumers are getting quality ingredients, 2) do research into the health benefits of dietary supplements, and 3) file new dietary ingredient notifications.
Additionally, a registration and product listing requirement needs teeth that would reduce the likelihood of fly-by-night marketers using rogue manufacturers to produce products that are on the shelf within 72 hours of a “Dr. Famous show.”
Regulators must accept that consumers are looking for alternatives to traditional medicine and we need to find a way forward that allows companies to make real claims that consumers will understand. We are wasting critical enforcement dollars on warning letters and regulatory actions related to cough-cold products, minor-to-moderate arthritis pain, inflammation, as well as pre-diabetes, prehypertension and cholesterol—which can all be addressed through lifestyle changes including appropriate use of targeted dietary supplements.
In this regard, I have been an advocate of amending DSHEA to permit disease claims for those diseases already deemed appropriate by FDA for over-the-counter medications if 1) the company files an appropriate petition with FDA showing that the intended use is consistent with the traditional use of ingredients in the product, or 2) the company conducts a clinical study on a clinical endpoint for a disease that has not progressed to the point of requiring drug therapy.
Both of these options would require changes in the law, but we already have a structure we can borrow from: the medical device provisions of the Act. We could create a 510k process for dietary supplements that would allow claims to be made for these diseases that are either already indicated for OTC use or are early onset. The process would be simple and would allow for the submission of testing protocols to FDA for its approval (we can create a user fee to use this service), and once the study is concluded the company is allowed to make the claim.
Many of my clients would line up tomorrow to do studies if they could make meaningful claims instead of the ridiculous claim of “helps support blood pressure levels already in the normal range.” How many people do any of us know who has 120/80 blood pressure and is going to take a supplement? None. How many people do we know who are either pre-hypertensive or stage 1 hypertension and would take a supplement that has been shown to reduce blood pressure? A lot. Does it not make sense from a policy standpoint, and a regulatory one, to permit these claims if the product is shown to be effective? The answer is unequivocally “yes,” and making FDA part of this process makes sense, but it also requires FDA to shed itself of its internal biases and work with the industry to achieve better health for the public.
Safety & Quality
I have already written at length on supply chain integrity but I am going to repeat myself that the Food Safety Modernization Act (FSMA) simply does not address quality of dietary ingredients—only the safety of ingredients. It is basically an HACCP plan for the food industry and ingredient suppliers. It does nothing to ensure that the ingredients are of sufficient quality to provide any benefits to the consumer.
I strongly urge the industry to support the Organic and Natural Health Association’s (ONHA) citizen petition to bring ingredient suppliers under Part 111. Yes, some provisions may need tweaking, but it is the best answer to ensure quality of dietary ingredients.
And, no, I am not a supporter of this petition because I also serve as ONHA’s president. Rather, I believe in quality products for consumers and not the junk that is too easily accessible by rogue marketers that purchase products from contract manufacturers more interested in making money than providing a high quality product—which brings me to my next recommendation in regard to registration and listing of products.
Product Registration
The cause célèbre lately in the industry is to have companies register and list all products with FDA. That sounds like an excellent proposal, but it has absolutely zero teeth. It is not hard to list and register with FDA; ask any company that distributes an OTC monograph drug product. The procedure is not difficult, although it has glitches. If you are serious about such a system, it needs to have teeth.
In this regard, I would borrow from the prescription drug world. If a prescription drug company fails to pay its user fees, then the drug is considered adulterated as a matter of law—yes, as matter of law. FDA only needs to prove the user fee is not paid. I suggest applying this concept, but not the user fee, to registration and listing for supplement companies. A company should be required 1) to be registered with FDA prior to introducing a product into commerce and 2) list that product with FDA prior to or within 30 days of first launch.
If a contract manufacturer produces a product for a private label distributor that is not registered with FDA, then all products manufactured by the manufacturer for that marketer shall be considered adulterated as a matter of law. Similarly, products that are not listed with FDA will be considered adulterated as a matter of law. Will this solve the problem completely? Of course not, but it may help eliminate some of these rogue marketers that make our industry look bad.
New Dietary Ingredients
New dietary ingredients are on top of my list of things that need a fix—and quickly. FDA has generally ignored this provision unless it believes there is a safety concern. The agency issued a draft guidance that was quickly walked back. The guidance was simply not workable and was inconsistent with the law. It made absurd distinctions about synthetics versus herbal ingredients. It created unnecessary burdens. When I look at the draft guidance, I have to admit, many of the requirements make sense if they had been implemented shortly after DSHEA was enacted, but not now 21 years later. Indeed, we cannot simply hit the reset button and act like all is fine.
Thus, we need to reset the grandfather date. While I believe FDA could do this through enforcement policy, it will not, so it requires a legislative fix. However, as part of the fix, the law must require FDA to compile an official list of grandfathered ingredients within one year based on notice and comment. I know the hesitancy in opening this provision, but quite frankly, nobody knows what a new dietary ingredient is and is not, including the agency.
2015 should have been a wake-up call for the industry, and regulators for that matter. It is time to update our statutory and regulatory framework to ensure that consumers have access to safe and effective dietary supplements with claims that convey the real purpose, whether the claim is based on traditional use or on clinical trials.
The regulators have forgotten the purpose of DSHEA was to promote the health of the citizenry and not to stand as an impediment to it. Simple changes are necessary and this column’s sole purpose is to serve as a jumping-off point to have an honest discussion of the changes that are required.
I hope 2016 brings that discussion and 2017 brings meaningful legislative and regulatory changes. Why 2017 for the changes? Because 2016 is an election year, so the likelihood of getting meaningful changes done is slim-to-none, but that does give us a year to craft legislation that can be ready to go in January 2017.
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
When the Dietary Supplement Health and Education Act (DSHEA) was passed back in 1994, we did not yet have the Internet, and outside of multivitamins the dietary supplement industry was still very much a nascent market that felt like it was under siege by regulators. DSHEA provided a much-needed reprieve from the constant barrage of unjustified enforcement actions. It created a safe haven that allowed the market to grow and flourish, but there was a dark side lurking underneath DSHEA that would arise at some point and cause another siege.
A Problematic Recipe
Specifically, DSHEA created a regulatory system that allowed anyone into the market regardless of intentions. It created a system of claims that do not allow for truthful communication about the purpose of products. Rather, DSHEA created a construct of absurd terms such as “joint comfort” and “already in the normal range.” It allowed lawyers—yes lawyers—to create legal constructs such as the two-click rule, and to develop reasonable legal arguments regarding why a new dietary ingredient notification was not required.
Added to the mix was a regulatory agency that decided not to enforce important provisions of DSHEA for more than a decade (probably closer to two decades), and another regulatory agency deciding that if the primary agency is not going to enforce the law then it would—based on its own internal biases against anything that does not fit squarely into its paradigm under the guise “we must protect consumers from unscrupulous peddlers of snake oil.”
This recipe created the perfect storm, and set us up for one of the most turbulent years the industry has faced in more than two decades. Law and policy have been turned on their heads. Reputable companies found themselves in the crosshairs of state attorneys general, contempt proceedings were brought against a company that was making rather simple digestive health claims (fortunately the court found that the FTC could not meet its burden), and FDA increased enforcement actions and warning letters.
All of this culminated in a show of force when the Department of Justice was joined at a press conference by FDA, FTC, the U.S. Postal Inspection Service, the Department of Defense and the U.S. Anti-Doping Agency to level one charge after another against the industry in one of the greatest shows of chest pounding that I have seen in my 53 years of life. One would think the industry was infiltrated by a terrorist group that threatened our very national security. Make no mistake about the purpose of that press conference; it was not to mention its recent actions, but to send a not-too-subtle message to the industry to get your house in order, or else.
A Coherent Regulatory System
What is the industry to do after a year in which it saw public confidence erode and the skepticism of government increase? Many measures have been suggested, ranging from voluntary company and product registration to compulsory registration. While I applaud these efforts, the proposals are merely cosmetic in nature and do not address issues of supply chain integrity, claims and new dietary ingredients. They will do little to stem the erosion of public confidence in the industry.
While I am not a fan of government regulation or intervention, it is time to develop a more coherent regulatory system. This system should be more consistent with how the general public uses dietary supplements and provide incentives to companies to 1) take the necessary steps to ensure that consumers are getting quality ingredients, 2) do research into the health benefits of dietary supplements, and 3) file new dietary ingredient notifications.
Additionally, a registration and product listing requirement needs teeth that would reduce the likelihood of fly-by-night marketers using rogue manufacturers to produce products that are on the shelf within 72 hours of a “Dr. Famous show.”
Regulators must accept that consumers are looking for alternatives to traditional medicine and we need to find a way forward that allows companies to make real claims that consumers will understand. We are wasting critical enforcement dollars on warning letters and regulatory actions related to cough-cold products, minor-to-moderate arthritis pain, inflammation, as well as pre-diabetes, prehypertension and cholesterol—which can all be addressed through lifestyle changes including appropriate use of targeted dietary supplements.
In this regard, I have been an advocate of amending DSHEA to permit disease claims for those diseases already deemed appropriate by FDA for over-the-counter medications if 1) the company files an appropriate petition with FDA showing that the intended use is consistent with the traditional use of ingredients in the product, or 2) the company conducts a clinical study on a clinical endpoint for a disease that has not progressed to the point of requiring drug therapy.
Both of these options would require changes in the law, but we already have a structure we can borrow from: the medical device provisions of the Act. We could create a 510k process for dietary supplements that would allow claims to be made for these diseases that are either already indicated for OTC use or are early onset. The process would be simple and would allow for the submission of testing protocols to FDA for its approval (we can create a user fee to use this service), and once the study is concluded the company is allowed to make the claim.
Many of my clients would line up tomorrow to do studies if they could make meaningful claims instead of the ridiculous claim of “helps support blood pressure levels already in the normal range.” How many people do any of us know who has 120/80 blood pressure and is going to take a supplement? None. How many people do we know who are either pre-hypertensive or stage 1 hypertension and would take a supplement that has been shown to reduce blood pressure? A lot. Does it not make sense from a policy standpoint, and a regulatory one, to permit these claims if the product is shown to be effective? The answer is unequivocally “yes,” and making FDA part of this process makes sense, but it also requires FDA to shed itself of its internal biases and work with the industry to achieve better health for the public.
Safety & Quality
I have already written at length on supply chain integrity but I am going to repeat myself that the Food Safety Modernization Act (FSMA) simply does not address quality of dietary ingredients—only the safety of ingredients. It is basically an HACCP plan for the food industry and ingredient suppliers. It does nothing to ensure that the ingredients are of sufficient quality to provide any benefits to the consumer.
I strongly urge the industry to support the Organic and Natural Health Association’s (ONHA) citizen petition to bring ingredient suppliers under Part 111. Yes, some provisions may need tweaking, but it is the best answer to ensure quality of dietary ingredients.
And, no, I am not a supporter of this petition because I also serve as ONHA’s president. Rather, I believe in quality products for consumers and not the junk that is too easily accessible by rogue marketers that purchase products from contract manufacturers more interested in making money than providing a high quality product—which brings me to my next recommendation in regard to registration and listing of products.
Product Registration
The cause célèbre lately in the industry is to have companies register and list all products with FDA. That sounds like an excellent proposal, but it has absolutely zero teeth. It is not hard to list and register with FDA; ask any company that distributes an OTC monograph drug product. The procedure is not difficult, although it has glitches. If you are serious about such a system, it needs to have teeth.
In this regard, I would borrow from the prescription drug world. If a prescription drug company fails to pay its user fees, then the drug is considered adulterated as a matter of law—yes, as matter of law. FDA only needs to prove the user fee is not paid. I suggest applying this concept, but not the user fee, to registration and listing for supplement companies. A company should be required 1) to be registered with FDA prior to introducing a product into commerce and 2) list that product with FDA prior to or within 30 days of first launch.
If a contract manufacturer produces a product for a private label distributor that is not registered with FDA, then all products manufactured by the manufacturer for that marketer shall be considered adulterated as a matter of law. Similarly, products that are not listed with FDA will be considered adulterated as a matter of law. Will this solve the problem completely? Of course not, but it may help eliminate some of these rogue marketers that make our industry look bad.
New Dietary Ingredients
New dietary ingredients are on top of my list of things that need a fix—and quickly. FDA has generally ignored this provision unless it believes there is a safety concern. The agency issued a draft guidance that was quickly walked back. The guidance was simply not workable and was inconsistent with the law. It made absurd distinctions about synthetics versus herbal ingredients. It created unnecessary burdens. When I look at the draft guidance, I have to admit, many of the requirements make sense if they had been implemented shortly after DSHEA was enacted, but not now 21 years later. Indeed, we cannot simply hit the reset button and act like all is fine.
Thus, we need to reset the grandfather date. While I believe FDA could do this through enforcement policy, it will not, so it requires a legislative fix. However, as part of the fix, the law must require FDA to compile an official list of grandfathered ingredients within one year based on notice and comment. I know the hesitancy in opening this provision, but quite frankly, nobody knows what a new dietary ingredient is and is not, including the agency.
2015 should have been a wake-up call for the industry, and regulators for that matter. It is time to update our statutory and regulatory framework to ensure that consumers have access to safe and effective dietary supplements with claims that convey the real purpose, whether the claim is based on traditional use or on clinical trials.
The regulators have forgotten the purpose of DSHEA was to promote the health of the citizenry and not to stand as an impediment to it. Simple changes are necessary and this column’s sole purpose is to serve as a jumping-off point to have an honest discussion of the changes that are required.
I hope 2016 brings that discussion and 2017 brings meaningful legislative and regulatory changes. Why 2017 for the changes? Because 2016 is an election year, so the likelihood of getting meaningful changes done is slim-to-none, but that does give us a year to craft legislation that can be ready to go in January 2017.
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
