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In the July 2023 print issue, Vitamin Retailer (VR) reached out to an expert panel about leadership, challenges and opportunities in the natural products industry, and here’s a continuation of what they had to say.
THE PANEL:
Corinna Bellizzi, Head of Sales & Marketing – US Nutraceuticals Division, Örlö Nutrition & VAXA Technologies, Wilmington, DE, https://orlonutrition.com
Ramona Billingslea, Marketing Manager, Betsy’s Health Foods, Spring, TX, https://betsyhealth.com
Blake Ebersole, President & Founder, NaturPro Scientific, Carmel, IN, http://naturproscientific.com
Jim Emme, CEO, NOW Health Group, Bloomingdale, IL, www.nowfoods.com
Jonathan Emord, President & Principal, Emord & Associates, Clifton, VA, https://emord.com
Karen Howard, CEO, Executive Director, Organic & Natural Health Association, Washington, D.C., https://organicandnatural.org
Mark LeDoux, Chairman & CEO, Natural Alternatives International, Carlsbad, CA, www.nai-online.com
Catherine Kwik-Uribe, PhD, Vice President of Scientific & Regulatory Affairs, Nutrition21, Saddle Brook, NJ, https://nutrition21.com
Betsy Lehrfeld, Board Chair, Citizens for Health, Washington, D.C., https://citizens.org
Len Monheit, CEO, Industry Transparency Center and Executive Director of the Global Prebiotic Association, Chicago, IL, https://itcstrategy.com
Steve Mister, President & CEO, CRN, Washington, D.C., https://crnusa.org
Elan Sudberg, CEO, Alkemist Labs, Garden Grove, CA, www.alkemist.com
Kyle Turk, Director of Government Affairs, Natural Products Association (NPA), Washington, D.C., www.npanational.org
Rob Verkerk, PhD, Executive and Scientific Director, Alliance for Natural Health USA and International, Edinburg, VA, https://anh-usa.org
VR: What’s going on with NMN? What do retailers need to be aware of?
LeDoux: Under strict interpretation of recent FDA activities, it appears that supplements containing NMN (a derivative of niacin found in natural metabolic processes in the human body) may be considered by the agency as inappropriate, while still allowing NMN to be present in non-supplement food forms, think protein or meal-replacement powders or RTD preparations – a matter which is somewhat confusing from a logical perspective.
Verkerk: Supplement companies have made significant business investments researching, marketing and selling NMN to consumers. That’s being rewarded by good sales, rave reviews, and many happy citizens who are winding back the years, probably taking pressure off groaning health care services. Yet, the FDA is in the process of allowing a pharmaceutical company to create a monopoly on NMN that will drive up the price of this ingredient and make it harder for consumers to access and benefit from. We recently joined with the Natural Products Association (NPA) to submit a Citizen’s Petition to the FDA urging the agency to reverse its determination that NMN is not a legal dietary supplement.
Turk: Absent any safety concerns retailers should continue to sell NMN. In March, the NPA submitted a citizen’s petition requesting a reevaluation of NMN by the FDA or an exercise of enforcement discretion on the drug exclusion clause for NMN. The agency does not have the statutory authority to reverse course on the NDI for NMN as a dietary supplement. Just like in the case of NAC, our citizen’s petition gives the industry a platform to work the agency on resolving this issue. Make no mistake, NPA will use every resource available to right this wrong.
Monheit: Despite initial acceptance of an NDIN, FDA later withdrew this acceptance and determined the drug exclusionary principle applied. for retailers, this means that FDA does not consider NMN as a lawful dietary ingredient so products containing it should not be sold.
Emord: FDA has deemed it unlawful for sale under the drug exclusion provision of DSHEA, which is further proof of the draconian abuse that provision is causing. Congress should revoke the provision.
Kwik-Uribe: Despite efforts by consumers, companies, and trade associations over the past few months, the FDA, disappointingly, has not changed their position. This feels like another attack on an industry that works to bring new innovations to market to support affordable, safe products that can maintain and improve their health. It is important for all parts of the supplement industry—from suppliers and distributors to brands and even consumers to work together, now more than ever, to ensure these products remain available and accessible to all the millions of consumers who use them daily to support their health.
Emme: The sale of NMN has been stopped by Amazon, and we have heard that the FDA is not issuing certificates of free sale for export of NMN products, which essentially stops the sale of NMN from the United States to other countries. We at NOW are not offering any NMN products, yet there are some brands still offering them to retailers. There is a citizens’ petition in place to stop the bans on the sale of NMN which is the same process that began with NAC. There is more yet to come before the final disposition of NMN is determined once and for all.
Mister: Despite FDA’s warning letters to several companies, there has been no official final agency action on this matter and there is no public indication that FDA has been willing to support its position with any enforcement activity. Purportedly, Amazon has announced it is removing all NMN supplements from its platform, but we believe that action is premature. With citizen petitions pending on this issue leaving this an open matter at FDA, companies should take that into consideration when determining if they will continue to offer NMN to their customers until the citizen petitions are resolved.
Billingslea: Because the FTC is over-reaching, we’ve seen the largest retailer, Amazon, decide to strip their site of the NMN products rather than contest the FTC’s actions. Having no skin in the game, they are quick to cover their bases, not caring what consumer rights might be trampled upon.
VR: Regarding the FDA, do you see a way forward for CBD as a dietary supplement ingredient? Please elaborate and indicate what retailers should prepare for.
Howard: As the states move forward with efforts to legalize marijuana, Congress will continue to be pressured to resolve the myriad of issues associated with cannabis, hemp and CBD. At the end of the day, the law should, and could, allow for full spectrum products. However, the FDA’s ultimate goal is most likely comprehensive cannabis legislation.
Until Congress actually legalizes marijuana, FDA could use such legislation language to promulgate regulations that allow for CBD and serve as a starting point to standardize the approach to cannabis legalization. A close, in-between the line, read of FDA’s denial indicates that is what FDA wants. Hemp and CBD give them the runway to develop the ultimate structure of how all these products are regulated.
Verkerk: The FDA has indicated it would like to heavily regulate CBD and group it with other cannabis-derived products, instead of more appropriately undergoing a rulemaking process to permit CBD in supplements. In our view, the FDA clearly has an interest in restricting or banning CBD supplements due to the existence of an FDA-approved CBD drug, Epidiolex. Due to the FDA’s lack of action, ANH believes this is an issue where Congress needs to act to legally permit CBD and related, non-psychoactive cannabinoids in dietary supplements.
Ebersole: The way forward is to acknowledge CBD like any other ingredient. Assess the safety and maximum dosage based on the GRAS and/or NDI standard for the dosages that have already been determined as safe. And acknowledge that a safe supplement dosage is going to be lower than an effective drug dosage.
Mister: FDA made apparent in January it has no intention of moving forward with a pathway for CBD in dietary supplements on its own. So, the action has moved back to Congress to direct the agency how it should establish an orderly over-the-counter marketplace with appropriate guardrails. Fortunately, one already exists: the dietary supplement category. As a botanical extract, CBD unmistakably qualifies as a dietary ingredient, and the safeguards that FDA claims to want for consumers — GMPs, adverse event reporting, oversight of labeling, the ability to limit unsafe levels — have already been established for supplements. CRN is working to build support on Capitol Hill for legislation that will mandate FDA properly treat CBD and other cannabinoids as dietary ingredients.
Emme: The future of a positive decision from the FDA is very uncertain. There are companies who are trying to get CBD approval and guidelines included in the next farm bill, but this seems unlikely at this time. The House and the Senate are fully occupied with getting the debt ceiling raised and a budget passed before the campaign season starts in August of this year, so the probability of a CDB solution coming out of Capitol Hill this year is very unlikely, in our view.
Emord: FDA is generally loathe to act against CBD. It has become ubiquitous in the market and, so, it will be difficult politically for the agency to force that free bird back into shackles.
Sudberg: It’s messy. Clearly the CBD flash in the pan has since expired, leaving a few legacy brands still standing along with the strongest and most science backed newer brands. Having started AHPA’s cannabis committee I would never have predicted the path Cannabis took but feel confident that eventually it will be considered a dietary supplement.
Monheit: FDA has moved this issue back to Congress so that’s where next steps must occur. At the same time, FDA has continued to message its concerns and belief that the path forward for CBD containing products is solely through the drug route. Cited reasons include cumulative consumption, absence of safety data (especially long-term) and by all appearances, an industry-unacceptable interpretation of DSHEA. In fact, under such interpretations, one could argue that traditional botanicals such as kava would not even cross the threshold were it presented today, certainly not the intention of the framers of DSHEA.
In the July 2023 print issue, Vitamin Retailer (VR) reached out to an expert panel about leadership, challenges and opportunities in the natural products industry, and here’s a continuation of what they had to say.
THE PANEL:
VR: What’s going on with NMN? What do retailers need to be aware of?
LeDoux: Under strict interpretation of recent FDA activities, it appears that supplements containing NMN (a derivative of niacin found in natural metabolic processes in the human body) may be considered by the agency as inappropriate, while still allowing NMN to be present in non-supplement food forms, think protein or meal-replacement powders or RTD preparations – a matter which is somewhat confusing from a logical perspective.
Verkerk: Supplement companies have made significant business investments researching, marketing and selling NMN to consumers. That’s being rewarded by good sales, rave reviews, and many happy citizens who are winding back the years, probably taking pressure off groaning health care services. Yet, the FDA is in the process of allowing a pharmaceutical company to create a monopoly on NMN that will drive up the price of this ingredient and make it harder for consumers to access and benefit from. We recently joined with the Natural Products Association (NPA) to submit a Citizen’s Petition to the FDA urging the agency to reverse its determination that NMN is not a legal dietary supplement.
Turk: Absent any safety concerns retailers should continue to sell NMN. In March, the NPA submitted a citizen’s petition requesting a reevaluation of NMN by the FDA or an exercise of enforcement discretion on the drug exclusion clause for NMN. The agency does not have the statutory authority to reverse course on the NDI for NMN as a dietary supplement. Just like in the case of NAC, our citizen’s petition gives the industry a platform to work the agency on resolving this issue. Make no mistake, NPA will use every resource available to right this wrong.
Monheit: Despite initial acceptance of an NDIN, FDA later withdrew this acceptance and determined the drug exclusionary principle applied. for retailers, this means that FDA does not consider NMN as a lawful dietary ingredient so products containing it should not be sold.
Emord: FDA has deemed it unlawful for sale under the drug exclusion provision of DSHEA, which is further proof of the draconian abuse that provision is causing. Congress should revoke the provision.
Kwik-Uribe: Despite efforts by consumers, companies, and trade associations over the past few months, the FDA, disappointingly, has not changed their position. This feels like another attack on an industry that works to bring new innovations to market to support affordable, safe products that can maintain and improve their health. It is important for all parts of the supplement industry—from suppliers and distributors to brands and even consumers to work together, now more than ever, to ensure these products remain available and accessible to all the millions of consumers who use them daily to support their health.
Emme: The sale of NMN has been stopped by Amazon, and we have heard that the FDA is not issuing certificates of free sale for export of NMN products, which essentially stops the sale of NMN from the United States to other countries. We at NOW are not offering any NMN products, yet there are some brands still offering them to retailers. There is a citizens’ petition in place to stop the bans on the sale of NMN which is the same process that began with NAC. There is more yet to come before the final disposition of NMN is determined once and for all.
Mister: Despite FDA’s warning letters to several companies, there has been no official final agency action on this matter and there is no public indication that FDA has been willing to support its position with any enforcement activity. Purportedly, Amazon has announced it is removing all NMN supplements from its platform, but we believe that action is premature. With citizen petitions pending on this issue leaving this an open matter at FDA, companies should take that into consideration when determining if they will continue to offer NMN to their customers until the citizen petitions are resolved.
Billingslea: Because the FTC is over-reaching, we’ve seen the largest retailer, Amazon, decide to strip their site of the NMN products rather than contest the FTC’s actions. Having no skin in the game, they are quick to cover their bases, not caring what consumer rights might be trampled upon.
VR: Regarding the FDA, do you see a way forward for CBD as a dietary supplement ingredient? Please elaborate and indicate what retailers should prepare for.
Howard: As the states move forward with efforts to legalize marijuana, Congress will continue to be pressured to resolve the myriad of issues associated with cannabis, hemp and CBD. At the end of the day, the law should, and could, allow for full spectrum products. However, the FDA’s ultimate goal is most likely comprehensive cannabis legislation.
Until Congress actually legalizes marijuana, FDA could use such legislation language to promulgate regulations that allow for CBD and serve as a starting point to standardize the approach to cannabis legalization. A close, in-between the line, read of FDA’s denial indicates that is what FDA wants. Hemp and CBD give them the runway to develop the ultimate structure of how all these products are regulated.
Verkerk: The FDA has indicated it would like to heavily regulate CBD and group it with other cannabis-derived products, instead of more appropriately undergoing a rulemaking process to permit CBD in supplements. In our view, the FDA clearly has an interest in restricting or banning CBD supplements due to the existence of an FDA-approved CBD drug, Epidiolex. Due to the FDA’s lack of action, ANH believes this is an issue where Congress needs to act to legally permit CBD and related, non-psychoactive cannabinoids in dietary supplements.
Ebersole: The way forward is to acknowledge CBD like any other ingredient. Assess the safety and maximum dosage based on the GRAS and/or NDI standard for the dosages that have already been determined as safe. And acknowledge that a safe supplement dosage is going to be lower than an effective drug dosage.
Mister: FDA made apparent in January it has no intention of moving forward with a pathway for CBD in dietary supplements on its own. So, the action has moved back to Congress to direct the agency how it should establish an orderly over-the-counter marketplace with appropriate guardrails. Fortunately, one already exists: the dietary supplement category. As a botanical extract, CBD unmistakably qualifies as a dietary ingredient, and the safeguards that FDA claims to want for consumers — GMPs, adverse event reporting, oversight of labeling, the ability to limit unsafe levels — have already been established for supplements. CRN is working to build support on Capitol Hill for legislation that will mandate FDA properly treat CBD and other cannabinoids as dietary ingredients.
Emme: The future of a positive decision from the FDA is very uncertain. There are companies who are trying to get CBD approval and guidelines included in the next farm bill, but this seems unlikely at this time. The House and the Senate are fully occupied with getting the debt ceiling raised and a budget passed before the campaign season starts in August of this year, so the probability of a CDB solution coming out of Capitol Hill this year is very unlikely, in our view.
Emord: FDA is generally loathe to act against CBD. It has become ubiquitous in the market and, so, it will be difficult politically for the agency to force that free bird back into shackles.
Sudberg: It’s messy. Clearly the CBD flash in the pan has since expired, leaving a few legacy brands still standing along with the strongest and most science backed newer brands. Having started AHPA’s cannabis committee I would never have predicted the path Cannabis took but feel confident that eventually it will be considered a dietary supplement.
Monheit: FDA has moved this issue back to Congress so that’s where next steps must occur. At the same time, FDA has continued to message its concerns and belief that the path forward for CBD containing products is solely through the drug route. Cited reasons include cumulative consumption, absence of safety data (especially long-term) and by all appearances, an industry-unacceptable interpretation of DSHEA. In fact, under such interpretations, one could argue that traditional botanicals such as kava would not even cross the threshold were it presented today, certainly not the intention of the framers of DSHEA.
