By Mike Montemarano, Associate Editor11.09.20
If any category in health and wellness has been required to adapt the most to radical changes COVID-19 has imposed on day-to-day life, it’s the sports/fitness industry. With a segment so heavily integrated into in-person athletic endeavors at gyms and competitions, how consumers incorporate nutraceuticals into their fitness routines is drastically different than it was a year ago. Likewise, the sports nutrition industry has observed some major changes in terms of attributes consumers are seeking from their dietary supplements.
Independent of the pandemic, the market has been experiencing some fundamental changes over the past 10-20 years that have resulted in a more all-encompassing picture of sports nutrition. In the past, the predominant focus of companies rested almost entirely on competitive or extreme athletes, rather than the everyday consumer or gym-goer looking for help in attaining personal wellness goals.
At the American Herbal Products Association’s (AHPA) Sports Nutrition Congress, held online this year, experts offered insights on research, supply chains, marketing, regulations, and other issues.
Top Level Trends
Tom Vierhile, vice president of strategic insights for market research firm Innova Market Insights, discussed sports nutrition trends found from consumer surveys and product launches.
Demand for clean-label products is becoming synonymous with plant-based, Vierhile said, as more consumers perceive plant-based ingredients to be “cleaner” or more health-promoting. In terms of sports nutrition, this concept can be seen in one of the most popular product types: protein shakes. Vegetarian is now one of the fastest-growing claims in sports nutrition product launches, according to Vierhile, overtaking both heart health and joint health claims. Soy protein isolate, which is highly valued for containing all nine amino acids, remains a clear winner used four times as frequently as its closest competitor, pea protein isolate. However, the jury is still not out on a number of competing ingredients, including chia, rice, and mushroom proteins.
“Plant-based won’t lose its foothold on the market,” Vierhile said. “People question the safety of animal product production these days as a result of COVID-19 to a certain extent, and the primary driver of veganism is health, while environmentalism plays a smaller part but certainly has something to do with it.”
“People are closing the door on animal-based ingredients when it comes to innovation,” Vierhile continued. “Other consumers may be looking at the plant-based space for the first time, and may see cardiovascular benefits in plant-based dieting. Increasing the capacity of the cardiovascular system is extremely important during the COVID-19 pandemic.”
Arla Foods Ingredients’ Mathias Toft Vangsoe said new opportunities are largely being propelled by a broadening of the sports nutrition category as a whole.
Sales of staples like protein bars, shakes, and powders, as well as non-protein sports nutrition products, were outpacing growth in gym memberships before 2020, by comfortable margins.
“These products now have a natural health halo, and people are trying to stay fit and exercise more than ever,” he said, describing fitness as a “new social class” much less constrained by age. This widening consumer base, he said, is a key driver in new delivery formats. A broad desire for snacks, cereal bars, and cookies from the more generalized functional foods consumer is also translating to sports nutrition product launches.
Selling to Stalwarts
While the sports nutrition industry is democratizing, and including different age groups and fitness levels, what can be said of new developments for sports nutrition stalwarts? According to Jack Gayton, senior buyer for The Vitamin Shoppe’s sports nutrition department, this specialty consumer base is leaning heavily into nutritional support in light of the limitations COVID-19 may be placing on their regimens. They also appear to be more well-read on any given product’s efficacy.
This year has been a positive for protein, Gayton said, especially plant-based, which grew 80% in sales by volume this year. He also noted significant gains for creatine, and double-digit growth in the testosterone-booster space, which has seen a great deal of product launches following clean-label and plant-based trends, as opposed to complex and questionable ingredients often scrutinized by anti-doping agencies.
For both traditional sports nutrition consumers and casual participants, energy has become a dominant trend. Anything to combat fatigue for the purposes of workout preparation or recovery is still a leading application in 2020. However, ingredients with narrow functions in terms of performance, such as lesser-known amino acids, have seen only marginal sales growth this year.
Finding the Right Formula
For Dr. James DiNicolantonio, director of scientific affairs for ingredient distributor AIDP, innovation doesn’t always entail a major disruption. “One can improve on currently-existing technologies, create new categories, formulate unique combinations of ingredients, or come up with a unique or convenient delivery method for any given ingredient,” he said, pointing to examples such as Magtein, a branded magnesium ingredient formulated to cross the blood-brain barrier.
Brands can also focus on potency, he said, as is the case with a number of AIDP’s sports nutrition ingredients. While certain products may appear conventional at face value, ramping up efficacy can make a world of difference. Expending resources into identifying novel ingredients may not necessarily have the payoff that synergistic combinations of well-researched ingredients have when it comes to developing a new product with a specific goal in mind.
Those working with more novel ingredients have a much greater burden of proof when it comes to substantiation, which can be great for a brand’s reputation if done the right way.
Sara Perez Ojalvo, director of research and development for Nutrition 21, described how to navigate challenges in ensuring that novel ingredients have staying power. Patent protection measures are an important first step to safeguard returns on investment into research. The patent application process allows for proactive approaches, with a three-year window permitted between receipt of a patent license and the development and commercialization of a product in the U.S.
For brands specializing in novel ingredients, it’s important to simplify; compounding on clinical substantiation is a better strategy than casting a wide net with a hefty portfolio of ingredients whose validity can be called into question.
“Do less and make fewer bets,” said Aaron Heidebreicht, vice president, FDMC and specialty, North America for Nutrabolt. Known for pre-workout brands C4, Xtend, and Cellucor, Nutrabolt found success by simplifying its portfolio and focusing on high-potential products, by reinvesting in research, and fine-tuning formulations.
“Discipline is key,” said Heidebreicht. “Don’t let temptations pose as opportunities. There will always be a new ingredient popping up, but you should lean into what’s tried and true, and build a brand block in retail that tells a story of that scientific accuracy and safety.”
Model Research
An ingredient’s journey should never end at commercialization, according to Hame Persaud, executive vice president of HP Ingredients, which continually looks for cost-effective ways to reaffirm clinical evidence and investigate new health applications.
“As a boutique supplier, we have two or three ingredients which we research as much as we can,” Persaud said. “We conduct dozens of trials for each ingredient we produce, to provide better protection for each of our claims […] To push science in a cost-effective way, you need to focus on context and relevance. We work to receive both grants and investments; sometimes financing comes from governments, or we co-finance research with other institutions. We take the view that we’re in for the long haul. Breakthroughs are certainly important to receive big dividends down the line, but our research provides us with a halo effect, going beyond science for science’s sake.”
Richard Kreider, executive director of the Exercise and Sports Nutrition Lab at Texas A&M University, described the advantages sports nutrition companies have seen in conducting research alongside academic institutions.
Benefits include access to a large pool of experts in the field, and extremely expensive academic facilities, along with a great degree of independence to the work being done. “Bridging brands and suppliers to academia gives them greater credibility, especially if these companies develop long-term relationships with universities, and research can be conducted independently,” Kreider said. Whether a trial is financed through a fee for service or grant, or a multi-year master agreement, at the end of the day, a supplier will own the IP. Companies also have the option of planning out a series of studies in which research can evolve, and new ideas can be implemented, through long-term agreements.
“A hybrid model, which combines in-house and outsourced research, is a model that’s worked for myself and other colleagues, and can offer the best of both worlds,” said Hector Lopez, CMO and partner of the Center for Applied Health Sciences. “Flexible licensing can mitigate both the risk and cost of research, and a brand can get involved very early or later on, depending how much risk they wish to take. This model allows you to leverage skill sets and trade secrets of smaller IP development firms, and they won’t have to hire new personnel or research staff, freeing up a brand to focus on marketing or distribution.”
“You can mitigate the potential loss of sole ownership of IP from start to finish,” Lopez continued. “There are competitive advantages lost if IP leaks, but there are things you can do to prevent this from happening.”
Given that academic research financed by sports nutrition companies is still driven by market demand and the need to reach consumers, Chris Lockwood, PhD, adjunct science editor for Bodybuilding.com, called for academia and marketing to bridge certain gaps in communication to benefit the end consumer.
“One of the biggest complaints within the industry is that research doesn’t clearly communicate safety and efficacy, and that academics don’t understand industry compliance whatsoever,” Lockwood said. “It’s an entirely different soapbox compared to researchers who investigate consumer products and make claims intended for widespread understanding. We as an industry can do a better job of synergizing; researchers often want to impress other PhD peers more than an audience of consumers or a company. Today, it’s less brands and more raw material suppliers who are investing in research, and many brands formulate with raw materials coming from India, China, and Japan, with most of the research being done on diseased populations, without DSHEA (Dietary Supplement Health and Education Act) compliance or other regulatory obligations.”
Compliance: High Standards & Vital Partnerships
Historically, the sports nutrition market has been subject to more unique standards of compliance and regulatory scrutiny than most other segments of the nutraceuticals industry.
The high-profile consequences of product safety, efficacy, and risk of adulteration when used by athletes is also reflected in perceptions of everyday consumers, who have become more discerning and demanding of brands.
Paul Klinger, business development director for LGC Science, said his company’s products are for more than just elite athletes. “Health-minded consumers care about quality assurance because they want to be safe, and you should absolutely sell safety. Our demographics are expanding to include active lifestyle and healthy living consumers, who choose brands based on credibility, confidence, and reputation. High school athletes are using our supplements for the first time.”
It’s been more than 25 years since the passage of DSHEA. According to David Trosin, managing director of health sciences certifications at NSF International, “In many regards, it seems like we’re at ground zero in terms of compliance. We often become a scapegoat; athletes caught using banned substances rarely do the right thing and admit guilt, and it’s often supplements that are pointed to. Sixty-six Olympians and pro athletes tested positive for adulterated supplements this year alone. The world is shrinking, influencers are global, and regional and global online retailers aren’t constrained by borders. Information is more accessible, global supply chains remain unknown in most cases, and NSF has tripled the number of its banned substances over the past decade. As soon as you find one substance, two more pop up; the cheaters are a step ahead.”
Third-party testing can help companies navigate the challenges and obstacles to reaching a gold standard of compliance. Ultimately though, there are no corners to cut when it comes to verifying the quality, authenticity, and legality of of products.
Douglas Kalman, vice president of scientific affairs for Nutrasource, described the value of product certifications and why they are becoming increasingly important to compete in today’s market.
“Certifications can focus on both competitive athletes and any engaged consumers,” he said. “Beyond testing for a widening list of banned substances, certifications can establish truth to label claims, affirm that the price of a product is fair, and adhere to the growing number of global agency guidelines necessary to meet anti-doping rules. Certifications for broader consumers can appeal to demands for non-GMO, clean label, and transparent labels. Guidance and product testing for label validation has meaning, and companies have an obligation to verify the identity of every ingredient, which is crucial in botanicals comprised of stems, leaves, and other aerial parts, each with unique bioactive compounds.”
Moreover, certifiers know when a relatively innocuous plant-based supplement will set off alarms, either because a substance is similar enough to one that is banned, or because something as simple as spinach extract can contain trace but detectable amounts of banned compounds.
In a global economy, successful companies must be fully adept at navigating a patchwork of regulatory frameworks, organizational guidelines, and quality standards, which is best left to those with worldly experience in compliance, Kalman said.
Third-party testing labs can confirm products are free from adulterants, contaminants, and banned substances. They can also verify product degradation over time, and confirm that compendial and lab-verified methodologies are used to ensure a precise analysis.
It’s rare to find one compendial method that works with every dietary supplement ingredient, said Darryl Sullivan, chief science officer and director of regulatory affairs at Eurofins. Amino acids and proteins, for instance, are notorious for interfering with chromatography, and having people in the process of certification who understand the challenging, complex matrices of testing is represented in gold-standard certifications. Opting for speed or low cost ahead of commericalization will cost a company in the long run, once products are independently tested and cross-referenced against competitors.
Oliver Catlin, president and co-founder of the Banned Substances Control Group, listed a number of ingredients he believes will pose the greatest challenge to supplement manufacturers in the years to come. Some nootropic supplements on the market today contain illegal ingredients, including noopept and piracetam, he said, along with performance enhancing drugs such as SARMS, GHRPs, ecdysterone, phenylethylamine derivatives, and more. Ecdysteroids, which are present in about 12% of plants used in dietary supplements, are also cause for concern, Catlin said.
“Popeye might have had some trouble due to the fact that ecdysterone is a primary ingredient in spinach extract,” he said. “Even something as simple as gum arabic, a widely-used filler, could have banned substances in it. And this is only the tip of the iceberg. We’re well-alerted to all of the big surprises that lay ahead in the botanicals arena, what’s still on the monitoring list, and anything that could be a problem during a drug test.”
Adverse event reporting (AER) is another important issue, and an area FDA inspectors will often target. Attorneys Rick Collins, partner at Collins Gann McCloskey and Barry PLLC; Jay Manfre, chief legal officer of Redcon1; and John Venardos, global regulatory and government affairs consultant at Venardos and Associates, said a solid standard operating procedure must be fully intact. All employees in a company’s customer service department must be trained in how to deal with phone and e-mail correspondence with a consumer regarding an adverse event, knowing never to offer medical advice, and recording as much medical information as possible, with an ideal follow-up period of at least one year.
On the topic of influencers and claims, “It’s especially dangerous to retweet, repost, or share an influencer’s post,” Collins said. “Doing so, and even liking a post on social media, implies that a company is making an express claim that the influencer’s claim was truthful and not misleading, and that it has clinical substantiation. Companies need to monitor endorsements with influencers they contract, with a standard operating procedure that influencers are obligated to work under. A ‘results aren’t typical’ disclaimer used to be a cover that companies constantly used, but the FTC stated, restated, and restated again that these technicality disclosures aren’t acceptable. Any claim an influencer makes must reflect typical results that a consumer can expect to see from a product.”
Independent of the pandemic, the market has been experiencing some fundamental changes over the past 10-20 years that have resulted in a more all-encompassing picture of sports nutrition. In the past, the predominant focus of companies rested almost entirely on competitive or extreme athletes, rather than the everyday consumer or gym-goer looking for help in attaining personal wellness goals.
At the American Herbal Products Association’s (AHPA) Sports Nutrition Congress, held online this year, experts offered insights on research, supply chains, marketing, regulations, and other issues.
Top Level Trends
Tom Vierhile, vice president of strategic insights for market research firm Innova Market Insights, discussed sports nutrition trends found from consumer surveys and product launches.
Demand for clean-label products is becoming synonymous with plant-based, Vierhile said, as more consumers perceive plant-based ingredients to be “cleaner” or more health-promoting. In terms of sports nutrition, this concept can be seen in one of the most popular product types: protein shakes. Vegetarian is now one of the fastest-growing claims in sports nutrition product launches, according to Vierhile, overtaking both heart health and joint health claims. Soy protein isolate, which is highly valued for containing all nine amino acids, remains a clear winner used four times as frequently as its closest competitor, pea protein isolate. However, the jury is still not out on a number of competing ingredients, including chia, rice, and mushroom proteins.
“Plant-based won’t lose its foothold on the market,” Vierhile said. “People question the safety of animal product production these days as a result of COVID-19 to a certain extent, and the primary driver of veganism is health, while environmentalism plays a smaller part but certainly has something to do with it.”
“People are closing the door on animal-based ingredients when it comes to innovation,” Vierhile continued. “Other consumers may be looking at the plant-based space for the first time, and may see cardiovascular benefits in plant-based dieting. Increasing the capacity of the cardiovascular system is extremely important during the COVID-19 pandemic.”
Arla Foods Ingredients’ Mathias Toft Vangsoe said new opportunities are largely being propelled by a broadening of the sports nutrition category as a whole.
Sales of staples like protein bars, shakes, and powders, as well as non-protein sports nutrition products, were outpacing growth in gym memberships before 2020, by comfortable margins.
“These products now have a natural health halo, and people are trying to stay fit and exercise more than ever,” he said, describing fitness as a “new social class” much less constrained by age. This widening consumer base, he said, is a key driver in new delivery formats. A broad desire for snacks, cereal bars, and cookies from the more generalized functional foods consumer is also translating to sports nutrition product launches.
Selling to Stalwarts
While the sports nutrition industry is democratizing, and including different age groups and fitness levels, what can be said of new developments for sports nutrition stalwarts? According to Jack Gayton, senior buyer for The Vitamin Shoppe’s sports nutrition department, this specialty consumer base is leaning heavily into nutritional support in light of the limitations COVID-19 may be placing on their regimens. They also appear to be more well-read on any given product’s efficacy.
This year has been a positive for protein, Gayton said, especially plant-based, which grew 80% in sales by volume this year. He also noted significant gains for creatine, and double-digit growth in the testosterone-booster space, which has seen a great deal of product launches following clean-label and plant-based trends, as opposed to complex and questionable ingredients often scrutinized by anti-doping agencies.
For both traditional sports nutrition consumers and casual participants, energy has become a dominant trend. Anything to combat fatigue for the purposes of workout preparation or recovery is still a leading application in 2020. However, ingredients with narrow functions in terms of performance, such as lesser-known amino acids, have seen only marginal sales growth this year.
Finding the Right Formula
For Dr. James DiNicolantonio, director of scientific affairs for ingredient distributor AIDP, innovation doesn’t always entail a major disruption. “One can improve on currently-existing technologies, create new categories, formulate unique combinations of ingredients, or come up with a unique or convenient delivery method for any given ingredient,” he said, pointing to examples such as Magtein, a branded magnesium ingredient formulated to cross the blood-brain barrier.
Brands can also focus on potency, he said, as is the case with a number of AIDP’s sports nutrition ingredients. While certain products may appear conventional at face value, ramping up efficacy can make a world of difference. Expending resources into identifying novel ingredients may not necessarily have the payoff that synergistic combinations of well-researched ingredients have when it comes to developing a new product with a specific goal in mind.
Those working with more novel ingredients have a much greater burden of proof when it comes to substantiation, which can be great for a brand’s reputation if done the right way.
Sara Perez Ojalvo, director of research and development for Nutrition 21, described how to navigate challenges in ensuring that novel ingredients have staying power. Patent protection measures are an important first step to safeguard returns on investment into research. The patent application process allows for proactive approaches, with a three-year window permitted between receipt of a patent license and the development and commercialization of a product in the U.S.
For brands specializing in novel ingredients, it’s important to simplify; compounding on clinical substantiation is a better strategy than casting a wide net with a hefty portfolio of ingredients whose validity can be called into question.
“Do less and make fewer bets,” said Aaron Heidebreicht, vice president, FDMC and specialty, North America for Nutrabolt. Known for pre-workout brands C4, Xtend, and Cellucor, Nutrabolt found success by simplifying its portfolio and focusing on high-potential products, by reinvesting in research, and fine-tuning formulations.
“Discipline is key,” said Heidebreicht. “Don’t let temptations pose as opportunities. There will always be a new ingredient popping up, but you should lean into what’s tried and true, and build a brand block in retail that tells a story of that scientific accuracy and safety.”
Model Research
An ingredient’s journey should never end at commercialization, according to Hame Persaud, executive vice president of HP Ingredients, which continually looks for cost-effective ways to reaffirm clinical evidence and investigate new health applications.
“As a boutique supplier, we have two or three ingredients which we research as much as we can,” Persaud said. “We conduct dozens of trials for each ingredient we produce, to provide better protection for each of our claims […] To push science in a cost-effective way, you need to focus on context and relevance. We work to receive both grants and investments; sometimes financing comes from governments, or we co-finance research with other institutions. We take the view that we’re in for the long haul. Breakthroughs are certainly important to receive big dividends down the line, but our research provides us with a halo effect, going beyond science for science’s sake.”
Richard Kreider, executive director of the Exercise and Sports Nutrition Lab at Texas A&M University, described the advantages sports nutrition companies have seen in conducting research alongside academic institutions.
Benefits include access to a large pool of experts in the field, and extremely expensive academic facilities, along with a great degree of independence to the work being done. “Bridging brands and suppliers to academia gives them greater credibility, especially if these companies develop long-term relationships with universities, and research can be conducted independently,” Kreider said. Whether a trial is financed through a fee for service or grant, or a multi-year master agreement, at the end of the day, a supplier will own the IP. Companies also have the option of planning out a series of studies in which research can evolve, and new ideas can be implemented, through long-term agreements.
“A hybrid model, which combines in-house and outsourced research, is a model that’s worked for myself and other colleagues, and can offer the best of both worlds,” said Hector Lopez, CMO and partner of the Center for Applied Health Sciences. “Flexible licensing can mitigate both the risk and cost of research, and a brand can get involved very early or later on, depending how much risk they wish to take. This model allows you to leverage skill sets and trade secrets of smaller IP development firms, and they won’t have to hire new personnel or research staff, freeing up a brand to focus on marketing or distribution.”
“You can mitigate the potential loss of sole ownership of IP from start to finish,” Lopez continued. “There are competitive advantages lost if IP leaks, but there are things you can do to prevent this from happening.”
Given that academic research financed by sports nutrition companies is still driven by market demand and the need to reach consumers, Chris Lockwood, PhD, adjunct science editor for Bodybuilding.com, called for academia and marketing to bridge certain gaps in communication to benefit the end consumer.
“One of the biggest complaints within the industry is that research doesn’t clearly communicate safety and efficacy, and that academics don’t understand industry compliance whatsoever,” Lockwood said. “It’s an entirely different soapbox compared to researchers who investigate consumer products and make claims intended for widespread understanding. We as an industry can do a better job of synergizing; researchers often want to impress other PhD peers more than an audience of consumers or a company. Today, it’s less brands and more raw material suppliers who are investing in research, and many brands formulate with raw materials coming from India, China, and Japan, with most of the research being done on diseased populations, without DSHEA (Dietary Supplement Health and Education Act) compliance or other regulatory obligations.”
Compliance: High Standards & Vital Partnerships
Historically, the sports nutrition market has been subject to more unique standards of compliance and regulatory scrutiny than most other segments of the nutraceuticals industry.
The high-profile consequences of product safety, efficacy, and risk of adulteration when used by athletes is also reflected in perceptions of everyday consumers, who have become more discerning and demanding of brands.
Paul Klinger, business development director for LGC Science, said his company’s products are for more than just elite athletes. “Health-minded consumers care about quality assurance because they want to be safe, and you should absolutely sell safety. Our demographics are expanding to include active lifestyle and healthy living consumers, who choose brands based on credibility, confidence, and reputation. High school athletes are using our supplements for the first time.”
It’s been more than 25 years since the passage of DSHEA. According to David Trosin, managing director of health sciences certifications at NSF International, “In many regards, it seems like we’re at ground zero in terms of compliance. We often become a scapegoat; athletes caught using banned substances rarely do the right thing and admit guilt, and it’s often supplements that are pointed to. Sixty-six Olympians and pro athletes tested positive for adulterated supplements this year alone. The world is shrinking, influencers are global, and regional and global online retailers aren’t constrained by borders. Information is more accessible, global supply chains remain unknown in most cases, and NSF has tripled the number of its banned substances over the past decade. As soon as you find one substance, two more pop up; the cheaters are a step ahead.”
Third-party testing can help companies navigate the challenges and obstacles to reaching a gold standard of compliance. Ultimately though, there are no corners to cut when it comes to verifying the quality, authenticity, and legality of of products.
Douglas Kalman, vice president of scientific affairs for Nutrasource, described the value of product certifications and why they are becoming increasingly important to compete in today’s market.
“Certifications can focus on both competitive athletes and any engaged consumers,” he said. “Beyond testing for a widening list of banned substances, certifications can establish truth to label claims, affirm that the price of a product is fair, and adhere to the growing number of global agency guidelines necessary to meet anti-doping rules. Certifications for broader consumers can appeal to demands for non-GMO, clean label, and transparent labels. Guidance and product testing for label validation has meaning, and companies have an obligation to verify the identity of every ingredient, which is crucial in botanicals comprised of stems, leaves, and other aerial parts, each with unique bioactive compounds.”
Moreover, certifiers know when a relatively innocuous plant-based supplement will set off alarms, either because a substance is similar enough to one that is banned, or because something as simple as spinach extract can contain trace but detectable amounts of banned compounds.
In a global economy, successful companies must be fully adept at navigating a patchwork of regulatory frameworks, organizational guidelines, and quality standards, which is best left to those with worldly experience in compliance, Kalman said.
Third-party testing labs can confirm products are free from adulterants, contaminants, and banned substances. They can also verify product degradation over time, and confirm that compendial and lab-verified methodologies are used to ensure a precise analysis.
It’s rare to find one compendial method that works with every dietary supplement ingredient, said Darryl Sullivan, chief science officer and director of regulatory affairs at Eurofins. Amino acids and proteins, for instance, are notorious for interfering with chromatography, and having people in the process of certification who understand the challenging, complex matrices of testing is represented in gold-standard certifications. Opting for speed or low cost ahead of commericalization will cost a company in the long run, once products are independently tested and cross-referenced against competitors.
Oliver Catlin, president and co-founder of the Banned Substances Control Group, listed a number of ingredients he believes will pose the greatest challenge to supplement manufacturers in the years to come. Some nootropic supplements on the market today contain illegal ingredients, including noopept and piracetam, he said, along with performance enhancing drugs such as SARMS, GHRPs, ecdysterone, phenylethylamine derivatives, and more. Ecdysteroids, which are present in about 12% of plants used in dietary supplements, are also cause for concern, Catlin said.
“Popeye might have had some trouble due to the fact that ecdysterone is a primary ingredient in spinach extract,” he said. “Even something as simple as gum arabic, a widely-used filler, could have banned substances in it. And this is only the tip of the iceberg. We’re well-alerted to all of the big surprises that lay ahead in the botanicals arena, what’s still on the monitoring list, and anything that could be a problem during a drug test.”
Adverse event reporting (AER) is another important issue, and an area FDA inspectors will often target. Attorneys Rick Collins, partner at Collins Gann McCloskey and Barry PLLC; Jay Manfre, chief legal officer of Redcon1; and John Venardos, global regulatory and government affairs consultant at Venardos and Associates, said a solid standard operating procedure must be fully intact. All employees in a company’s customer service department must be trained in how to deal with phone and e-mail correspondence with a consumer regarding an adverse event, knowing never to offer medical advice, and recording as much medical information as possible, with an ideal follow-up period of at least one year.
On the topic of influencers and claims, “It’s especially dangerous to retweet, repost, or share an influencer’s post,” Collins said. “Doing so, and even liking a post on social media, implies that a company is making an express claim that the influencer’s claim was truthful and not misleading, and that it has clinical substantiation. Companies need to monitor endorsements with influencers they contract, with a standard operating procedure that influencers are obligated to work under. A ‘results aren’t typical’ disclaimer used to be a cover that companies constantly used, but the FTC stated, restated, and restated again that these technicality disclosures aren’t acceptable. Any claim an influencer makes must reflect typical results that a consumer can expect to see from a product.”