By Sean Moloughney, Editor12.04.23
Part 1: FDA Restructuring and FTC Activity
Part 2: Supplement Access, Safety, and CBD
Part 3: Communication, Education, and Trust
Part 4: Advanced/Advancing Technologies and Research
Part 5: Advocating Best Practices
Part 6: Business Trends and Innovation
NW: FDA has questioned the legality of several ingredients sold in the dietary supplement marketplace in the context of the drug preclusion clause of DSHEA (the Dietary Supplement Health and Education Act). Meanwhile, the state of New York recently restricted access to certain weight loss and muscle building products from people under 18. How do you see the balance of access and safety in today’s dietary supplement marketplace? How do you think the collective industry should approach these issues?
Steve Mister, President and CEO, Council for Responsible Nutrition (CRN): What’s happening in New York with weight loss and sports nutrition products, and what’s going on at FDA regarding drug preclusion are two very different initiatives with very different objectives, and very different players who are pushing these agendas. But I think it’s very astute to note that both would affect access to dietary supplements.
Ensuring consumers have easy access to a broad range of safe and effective supplements has been the challenge for this industry going back before DSHEA, and it certainly has pervaded in the 30 years since DSHEA was passed.
It’s particularly concerning that New York’s legislature would put age restrictions on weight loss and sports nutrition products without a sound reason for doing so. The proponents of this measure insist there is a causal connection with these products. Yet there is absolutely no evidence proving these products cause eating disorders and body dysmorphia, which are both very complex issues with a multitude of social and psychological causes. Our products are simply not to blame for this, but we are being scapegoated by the proponents.
Meanwhile, here in Washington, FDA is using drug preclusion to tilt the balance of innovation in favor of the pharmaceutical firms instead of incentivizing innovation for supplements when they broadly construe drug preclusion to essentially give the drug side of the marketplace a monopoly on ingredients that have been in our space for years.
Something is out of whack which is why we filed our citizen petition and that’s why we are meeting with FDA so we can discuss other solutions. It’s also why we are working on legislation that would change the statute and revise drug preclusion. But both issues have a potential negative impact on access.
"Unfortunately, the legislation will ultimately do more harm than good, jeopardizing consumer access to the safe, beneficial, and well-regulated dietary supplements that millions of New Yorkers rely on every day to support their overall health and wellness."
Duffy MacKay, Senior Vice President, Dietary Supplements, Consumer Healthcare Products Association (CHPA): CHPA was disappointed to see the New York State legislation signed into law, no matter how well-intentioned it might have been. We urged Governor Kathy Hochul to take a more balanced approach on this issue since the bill’s overly broad language will not just affect dietary supplements that are marketed for weight loss, but also other products that utilize a particular set of ingredients, including many used in popular supplements unrelated to weight loss.
Unfortunately, the legislation will ultimately do more harm than good, jeopardizing consumer access to the safe, beneficial, and well-regulated dietary supplements that millions of New Yorkers rely on every day to support their overall health and wellness.
Daniel Fabricant, PhD, President and CEO, Natural Products Association (NPA): The industry has a great deal of apathy, making us vulnerable to state attacks and the coming federal attacks. Companies are happy to spend more and more money on marketing, sponsorships, and frills. Still, the industry’s lack of spending and involvement dedicated to public policy is quite deficient and is starting to come home to roost.
We know that the industry has a wonderful safety record, and we view these attacks as unfounded. While we view the industry’s critics as not a real threat, and frankly, times have been good ... because things have been so successful, the behavior has been representative of a “why does my company need to be involved” mindset. When we look at it, the majority of the industry has never contributed to advancing public policy initiatives and politics, or reached out to those who are in office to help us fight off these attacks—let alone met with their elected officials to put a name with a face—yet (companies) expect that everything will turn out okay on its own.
The government can and will change your business faster than anything else, and the changes they want aren’t going to help to grow the industry. The collective approach must be involvement, and involvement like other industries that face these threats. Whether they align with our values or not, we must fight like they do tactic-wise. Just (recently) in Massachusetts, we were told the strategies used for tobacco should be used (against) our industry—let that sink in. While we know we aren’t tobacco, if we’re going to be viewed by our critics in that regard, how are we going to stave off the attacks by responding with lesser firepower?
As for DSHEA reform, the only (changes) that people should be looking at are fixes to the drug preclusion criteria. Otherwise, DSHEA has struck the appropriate balance between access and choice.
Loren Israelsen, President, United Natural Products Alliance (UNPA) (on state restrictions): State restrictions on products, whether weight loss, muscle building, CBD, or other things, are generally ineffective, but legislatures feel the need to “act” to protect young people. This is understandable. As always, education is a more effective approach, but it is seldom the primary approach to balance safety and access to products that may not be appropriate for younger people.
NW: A number of food additives deemed safe decades ago are coming under increased scrutiny. California’s Food Safety Act has banned several substances—and FDA recently followed suit by proposing a federal ban on brominated vegetable oil (BVO) while also announcing a review of other additives. What do you make of this development and tension between states and FDA?
Daniel Fabricant: This happened at the state level first and now is at the federal level, which is the tail wagging the dog. These issues should be federal as that’s where the expertise is, and these are items in interstate commerce. These issues shouldn’t be political, as in this case; BVO was politicized in California, and now, because of that, the federal government is doing an about-face when for 40-50 years it was “safe.”
This, along with the age-restriction bills, makes the case for state pre-emption being a top, if not the top, priority. The industry needs one clear regulator, not 51.
Loren Israelsen: California’s recent Food Safety Act banning some pretty nasty food additives was a great start, and, in my judgment, FDA should have done so some time ago. We now see FDA beginning to reexamine old (50- to 60-year-old) food safety reviews that are no longer valid, given the change in demographics, new industrial processes used to make food additives, and effects on young children and the unborn. Safe food is not static, and today there are many food additives that should be removed from the market. If California has to nudge FDA to get the job done, so be it.
Steve Mister: It’s not surprising that when states perceive FDA is not moving quick enough and not being aggressive enough in reviewing science, they decide to step into that vacuum and take action themselves. I think that’s what we saw recently in California and other states that are even now still looking at titanium dioxide. FDA should be the lead dog when it comes to reviewing the safety of food chemicals, so FDA should be doing more. They recently said they will be evaluating the titanium dioxide citizens petition that was filed.
What they’re doing with brominated vegetable oils is demonstrating federal sovereignty, and that’s what they should be doing. These kinds of decisions need to be made by FDA. They are the experts on food and chemicals, and should be making decisions for the entire nation. If you don’t have a central authority making these decisions based on science, you get very politicized responses from the states, along with a patchwork of different laws where an ingredient might be available in some places and not in others. That makes it very difficult for manufacturers to have a single distribution program for all of their products, or they simply will have to pull an ingredient off the market in every state just because it’s been banned in one state. And that’s not the way we should be governing this country.
Duffy MacKay: CHPA remains concerned with any state action on FDA-approved color additives, as differing state-by-state regulatory standards have the potential to weaken our nation’s food system and safety efforts. Industry and consumers rely on FDA to maintain a strong, science-driven, national food safety focus. It is not sustainable to fluctuate to the whims of individuals and groups like EDF (Environmental Defense Fund) that rely on weak science to bend state laws, or by petitioning FDA to ban ingredients.
FDA’s proposed ban of BVO, recently announced by the new Deputy Commissioner for Human Foods, Jim Jones, will hopefully send a message to state legislators that this issue is best handled through uniform standards at the federal level. CHPA is actively engaged with FDA on the proposed reorganization of the Human Foods Program, which includes the establishment of the Office of Food Chemical Safety, Dietary Supplements, and Innovation, designed to streamline the process for assessing chemicals in the food supply, which should further raise the confidence of state lawmakers that FDA is the appropriate regulator to assess the safety of food.
Sibyl Swift, PhD, Chief Science Officer and VP of Regulatory Affairs, cbdMD, Inc./CBD Industries, LLC: The net effect of FDA inaction has caused the hemp industry, including farmers, processors, manufacturers, and retailers to languish. The industry was predicted to grow to $20 billion but instead has failed to hit that mark and is in a holding pattern.
States have stepped up by passing legislation to provide consumers access to hemp-derived products while ensuring they are protected from harm. In doing so, there is now a patchwork of state laws that are well-intentioned, but cause confusion and hinder responsible manufacturers from producing products when they must comply with varied state standards, rather than one federal standard. The lack of action has also led to the proliferation of unregulated products, which raise quality and safety issues and are often confused with hemp-derived cannabinoid products. FDA action would include the removal of those products from the market and access to safe, efficacious products.
We take an active role in advocating for clarity at the federal level and educating our customers with information backed by science. We work with our trade associations, the Natural Products Association and the U.S. Hemp Roundtable, and also independently, to elevate the profile of this issue in Congress. We provided written testimony to the Oversight Committee Hearing in July 2023 and submitted a response to the Congressional RFI (Request for Information) in August 2023. We have chosen to lead by example and invest in science and quality to ensure our customers have access to safe, naturally derived products for everyday health and wellness.
Nicole Brown, Chief Innovation Officer, Open Book Extracts (OBX): Since the inception of Open Book Extracts in 2019, the company has served as a leader in the hemp-based CBD market, prioritizing science, safety, and responsible commerce. In response to the persisting stalemate for CBD industry regulations, in September Open Book Extracts (OBX) announced its founding membership in ONE HEMP, a coalition of top CBD industry stakeholders to support Congress and the U.S. Food and Drug Administration through a science and data-backed approach to arrive at sensible dietary supplement regulation.
ONE HEMP unites leading CBD industry stakeholders in a pivotal moment to work toward more stringent regulatory standards, including independent third-party testing and accurate labeling. As a founding member, OBX is joined in the coalition by BayMedica, Charlotte’s Web, Hemp Beverage Alliance, Kazmira, MAD TASTY, and WYLD, among numerous others. ONE HEMP took a milestone step by submitting to Congressional leaders comprehensive new insights and safety studies in response to a Request for Information from the House and Senate committees of jurisdiction. ONE HEMP is confident that the time for federal CBD policy reform has arrived during this Congressional session and is fully prepared to be the leading subject-matter resource for bipartisan action to support Congress and collaborate with the FDA.
ONE HEMP will offer policymakers a science-backed and safety-minded industry resource for the development of a regulatory approach that aligns with the need to ensure access for the more than 45 million Americans who rely on the benefits of CBD every day, including seniors, families, athletes, military veterans, and others. With ONE HEMP, OBX will continue to offer Congress science-backed policy solutions, including an FDA mandate to regulate hemp-derived products through the existing regulatory framework for dietary supplements. ONE HEMP advocates for industry requirements to disclose hemp-derived product warning statements, addressing the FDA’s public risk concerns and product safety and non-impairment recognition at certain dose levels based on credible scientific data.
Part 2: Supplement Access, Safety, and CBD
Part 3: Communication, Education, and Trust
Part 4: Advanced/Advancing Technologies and Research
Part 5: Advocating Best Practices
Part 6: Business Trends and Innovation
NW: FDA has questioned the legality of several ingredients sold in the dietary supplement marketplace in the context of the drug preclusion clause of DSHEA (the Dietary Supplement Health and Education Act). Meanwhile, the state of New York recently restricted access to certain weight loss and muscle building products from people under 18. How do you see the balance of access and safety in today’s dietary supplement marketplace? How do you think the collective industry should approach these issues?
Steve Mister, President and CEO, Council for Responsible Nutrition (CRN): What’s happening in New York with weight loss and sports nutrition products, and what’s going on at FDA regarding drug preclusion are two very different initiatives with very different objectives, and very different players who are pushing these agendas. But I think it’s very astute to note that both would affect access to dietary supplements.
Ensuring consumers have easy access to a broad range of safe and effective supplements has been the challenge for this industry going back before DSHEA, and it certainly has pervaded in the 30 years since DSHEA was passed.
It’s particularly concerning that New York’s legislature would put age restrictions on weight loss and sports nutrition products without a sound reason for doing so. The proponents of this measure insist there is a causal connection with these products. Yet there is absolutely no evidence proving these products cause eating disorders and body dysmorphia, which are both very complex issues with a multitude of social and psychological causes. Our products are simply not to blame for this, but we are being scapegoated by the proponents.
Meanwhile, here in Washington, FDA is using drug preclusion to tilt the balance of innovation in favor of the pharmaceutical firms instead of incentivizing innovation for supplements when they broadly construe drug preclusion to essentially give the drug side of the marketplace a monopoly on ingredients that have been in our space for years.
Something is out of whack which is why we filed our citizen petition and that’s why we are meeting with FDA so we can discuss other solutions. It’s also why we are working on legislation that would change the statute and revise drug preclusion. But both issues have a potential negative impact on access.
"Unfortunately, the legislation will ultimately do more harm than good, jeopardizing consumer access to the safe, beneficial, and well-regulated dietary supplements that millions of New Yorkers rely on every day to support their overall health and wellness."
— Duffy MacKay, Consumer Healthcare Products Association
Duffy MacKay, Senior Vice President, Dietary Supplements, Consumer Healthcare Products Association (CHPA): CHPA was disappointed to see the New York State legislation signed into law, no matter how well-intentioned it might have been. We urged Governor Kathy Hochul to take a more balanced approach on this issue since the bill’s overly broad language will not just affect dietary supplements that are marketed for weight loss, but also other products that utilize a particular set of ingredients, including many used in popular supplements unrelated to weight loss.
Unfortunately, the legislation will ultimately do more harm than good, jeopardizing consumer access to the safe, beneficial, and well-regulated dietary supplements that millions of New Yorkers rely on every day to support their overall health and wellness.
Daniel Fabricant, PhD, President and CEO, Natural Products Association (NPA): The industry has a great deal of apathy, making us vulnerable to state attacks and the coming federal attacks. Companies are happy to spend more and more money on marketing, sponsorships, and frills. Still, the industry’s lack of spending and involvement dedicated to public policy is quite deficient and is starting to come home to roost.
We know that the industry has a wonderful safety record, and we view these attacks as unfounded. While we view the industry’s critics as not a real threat, and frankly, times have been good ... because things have been so successful, the behavior has been representative of a “why does my company need to be involved” mindset. When we look at it, the majority of the industry has never contributed to advancing public policy initiatives and politics, or reached out to those who are in office to help us fight off these attacks—let alone met with their elected officials to put a name with a face—yet (companies) expect that everything will turn out okay on its own.
The government can and will change your business faster than anything else, and the changes they want aren’t going to help to grow the industry. The collective approach must be involvement, and involvement like other industries that face these threats. Whether they align with our values or not, we must fight like they do tactic-wise. Just (recently) in Massachusetts, we were told the strategies used for tobacco should be used (against) our industry—let that sink in. While we know we aren’t tobacco, if we’re going to be viewed by our critics in that regard, how are we going to stave off the attacks by responding with lesser firepower?
As for DSHEA reform, the only (changes) that people should be looking at are fixes to the drug preclusion criteria. Otherwise, DSHEA has struck the appropriate balance between access and choice.
"State restrictions on products ... are generally ineffective, but legislatures feel the need to 'act' to protect young people ... As always, education is a more effective approach, but it is seldom the primary approach to balance safety and access to products that may not be appropriate for younger people."
— Loren Israelsen, United Natural Products Alliance
NW: A number of food additives deemed safe decades ago are coming under increased scrutiny. California’s Food Safety Act has banned several substances—and FDA recently followed suit by proposing a federal ban on brominated vegetable oil (BVO) while also announcing a review of other additives. What do you make of this development and tension between states and FDA?
Daniel Fabricant: This happened at the state level first and now is at the federal level, which is the tail wagging the dog. These issues should be federal as that’s where the expertise is, and these are items in interstate commerce. These issues shouldn’t be political, as in this case; BVO was politicized in California, and now, because of that, the federal government is doing an about-face when for 40-50 years it was “safe.”
This, along with the age-restriction bills, makes the case for state pre-emption being a top, if not the top, priority. The industry needs one clear regulator, not 51.
Loren Israelsen: California’s recent Food Safety Act banning some pretty nasty food additives was a great start, and, in my judgment, FDA should have done so some time ago. We now see FDA beginning to reexamine old (50- to 60-year-old) food safety reviews that are no longer valid, given the change in demographics, new industrial processes used to make food additives, and effects on young children and the unborn. Safe food is not static, and today there are many food additives that should be removed from the market. If California has to nudge FDA to get the job done, so be it.
Steve Mister: It’s not surprising that when states perceive FDA is not moving quick enough and not being aggressive enough in reviewing science, they decide to step into that vacuum and take action themselves. I think that’s what we saw recently in California and other states that are even now still looking at titanium dioxide. FDA should be the lead dog when it comes to reviewing the safety of food chemicals, so FDA should be doing more. They recently said they will be evaluating the titanium dioxide citizens petition that was filed.
What they’re doing with brominated vegetable oils is demonstrating federal sovereignty, and that’s what they should be doing. These kinds of decisions need to be made by FDA. They are the experts on food and chemicals, and should be making decisions for the entire nation. If you don’t have a central authority making these decisions based on science, you get very politicized responses from the states, along with a patchwork of different laws where an ingredient might be available in some places and not in others. That makes it very difficult for manufacturers to have a single distribution program for all of their products, or they simply will have to pull an ingredient off the market in every state just because it’s been banned in one state. And that’s not the way we should be governing this country.
Duffy MacKay: CHPA remains concerned with any state action on FDA-approved color additives, as differing state-by-state regulatory standards have the potential to weaken our nation’s food system and safety efforts. Industry and consumers rely on FDA to maintain a strong, science-driven, national food safety focus. It is not sustainable to fluctuate to the whims of individuals and groups like EDF (Environmental Defense Fund) that rely on weak science to bend state laws, or by petitioning FDA to ban ingredients.
FDA’s proposed ban of BVO, recently announced by the new Deputy Commissioner for Human Foods, Jim Jones, will hopefully send a message to state legislators that this issue is best handled through uniform standards at the federal level. CHPA is actively engaged with FDA on the proposed reorganization of the Human Foods Program, which includes the establishment of the Office of Food Chemical Safety, Dietary Supplements, and Innovation, designed to streamline the process for assessing chemicals in the food supply, which should further raise the confidence of state lawmakers that FDA is the appropriate regulator to assess the safety of food.
"The net effect of FDA inaction has caused the hemp industry, including farmers, processors, manufacturers, and retailers to languish. The industry was predicted to grow to $20 billion but instead has failed to hit that mark and is in a holding pattern."
— Sibyl Swift, cbdMD, Inc.
CBD
NW: The ultimate fate of CBD is still uncertain. FDA continues to express safety concerns and has requested a new regulatory pathway from Congress, which has more pressing matters to address right now. The market has clearly suffered as a result. How are you navigating this stalemate and what are your expectations at this point?Sibyl Swift, PhD, Chief Science Officer and VP of Regulatory Affairs, cbdMD, Inc./CBD Industries, LLC: The net effect of FDA inaction has caused the hemp industry, including farmers, processors, manufacturers, and retailers to languish. The industry was predicted to grow to $20 billion but instead has failed to hit that mark and is in a holding pattern.
States have stepped up by passing legislation to provide consumers access to hemp-derived products while ensuring they are protected from harm. In doing so, there is now a patchwork of state laws that are well-intentioned, but cause confusion and hinder responsible manufacturers from producing products when they must comply with varied state standards, rather than one federal standard. The lack of action has also led to the proliferation of unregulated products, which raise quality and safety issues and are often confused with hemp-derived cannabinoid products. FDA action would include the removal of those products from the market and access to safe, efficacious products.
We take an active role in advocating for clarity at the federal level and educating our customers with information backed by science. We work with our trade associations, the Natural Products Association and the U.S. Hemp Roundtable, and also independently, to elevate the profile of this issue in Congress. We provided written testimony to the Oversight Committee Hearing in July 2023 and submitted a response to the Congressional RFI (Request for Information) in August 2023. We have chosen to lead by example and invest in science and quality to ensure our customers have access to safe, naturally derived products for everyday health and wellness.
Nicole Brown, Chief Innovation Officer, Open Book Extracts (OBX): Since the inception of Open Book Extracts in 2019, the company has served as a leader in the hemp-based CBD market, prioritizing science, safety, and responsible commerce. In response to the persisting stalemate for CBD industry regulations, in September Open Book Extracts (OBX) announced its founding membership in ONE HEMP, a coalition of top CBD industry stakeholders to support Congress and the U.S. Food and Drug Administration through a science and data-backed approach to arrive at sensible dietary supplement regulation.
ONE HEMP unites leading CBD industry stakeholders in a pivotal moment to work toward more stringent regulatory standards, including independent third-party testing and accurate labeling. As a founding member, OBX is joined in the coalition by BayMedica, Charlotte’s Web, Hemp Beverage Alliance, Kazmira, MAD TASTY, and WYLD, among numerous others. ONE HEMP took a milestone step by submitting to Congressional leaders comprehensive new insights and safety studies in response to a Request for Information from the House and Senate committees of jurisdiction. ONE HEMP is confident that the time for federal CBD policy reform has arrived during this Congressional session and is fully prepared to be the leading subject-matter resource for bipartisan action to support Congress and collaborate with the FDA.
ONE HEMP will offer policymakers a science-backed and safety-minded industry resource for the development of a regulatory approach that aligns with the need to ensure access for the more than 45 million Americans who rely on the benefits of CBD every day, including seniors, families, athletes, military veterans, and others. With ONE HEMP, OBX will continue to offer Congress science-backed policy solutions, including an FDA mandate to regulate hemp-derived products through the existing regulatory framework for dietary supplements. ONE HEMP advocates for industry requirements to disclose hemp-derived product warning statements, addressing the FDA’s public risk concerns and product safety and non-impairment recognition at certain dose levels based on credible scientific data.
