Chocolate is an unusual ingredient in that it is considered a decadent indulgence while also carrying a healthy halo that makes it a not-so-guilty pleasure. While sugar-rich options are a favorite, more gourmet, cocoa-rich dark chocolate options offer a compromise between indulgence and health. You may have even noticed more dark chocolate options of your favorite chocolate treats.

“The increase in dark chocolate has to do with the increasing demand for options that are better for overall health,” explains Marcela Jaramillo, vice president of marketing at chocolates manufacturer Luker Chocolate (Bogotá, Colombia). “Chocolate is credited with extensive health benefits particularly related to its antioxidant content, and these are particularly more present in high-cocoa-content chocolates.”

Jaramillo adds, “With a higher consumer focus on plant-based diets, dark chocolate has also become a great option for a diet-friendly treat. The market is also offering more variety in dark chocolates, particularly in the premium segment, thus allowing consumers to try different origins and venture into more sophisticated creations.”

According to Barry Callebaut’s report “Top Chocolate Trends: 2023 & Beyond,” citing data from Euromonitor, the chocolate confectionery market is expected to be worth over $128 billion in global retail sales by the end of 2023. By 2025, there is expected to be a 1.9% compound annual growth rate in volume. This same report explains that 54% of North American consumers enjoy moments of indulgence during which they pay little to no attention to nutritional intake. Additionally, 59% actively seek out premium versions of their favorite chocolate, up 10% from the previous two years. Balance is key, it seems, as the same reports states that 73% of U.S. consumers agree that there is a place for chocolate in a healthy diet.

Manufacturers can use a variety of methods to accommodate health-conscious consumers seeking indulgence. For example, sugar reduction is something they are highly receptive to and actively seek out on nutrition facts panels. According to Barry Callebaut, 48% of North American consumers want low-sugar chocolate, which is up by 17% compared to two years ago. Over the last five years, sugar-free chocolate has doubled in sales, now worth $260 million in retail sales.

Portion size is another way to control how healthy or unhealthy one’s chocolate intake can be perceived, according to Luker’s Jaramillo. “Smaller portion sizes are always an excellent choice for those looking to indulge in better-for-you treats. Our 0.28-oz (8 g) bar is perfectly sized for an indulgent, single bite,” Jaramillo says. “Alternative sweeteners such as allulose or maltitol have gained popularity in the chocolate confectionery category and make for tasty options for consumers who cannot consume sugar or wish to reduce their caloric intake. These sugar-free chocolate options provide a guilt-free indulgence while fully satisfying cravings.”

Thom King, CEO of Icon Foods (Portland, OR), points out that the type of sweetener you use in your chocolate product may impact how it can be labeled. “So technically, if chocolate doesn’t contain sugar, it doesn’t fall under the standard of identity the U.S. Food and Drug Administration has for chocolate,” King explains. “So chocolate has to have a sweetener in it that is classified as a carbohydrate.”

Allulose would fall into this category of a carbohydrate. However, if a product does not have a sweetener classified as a carbohydrate, it would have to be labeled as “chocolate flavored” rather than chocolate. Offering smaller, bite-sized portions also offers some flexibility to the manufacturer. Luker Chocolate explains in a blog post

 that bite-sized snacks allow brands to “experiment with new flavors and ingredients without the risk of a large-scale product launch.”

For those who are vegan or interested in eating less animal-based products, Luker also offers oat milk chocolate as a plant-based alternative to everyone’s favorite milk chocolate. These fall under the company’s line of “Balance” products that provide a healthier and label-friendly alternative to traditional chocolate products.

And for those looking for a good vehicle for functional ingredients, chocolate may be a good fit as well. “Consumers want more nutritional and functional benefits from the foods they eat, and chocolate is a great carrier as it is able to improve the overall taste experience and can be easily used in snacking, drinking, and baking products,” Jaramillo says. “Protein additions, particularly plant-based, are what we are seeing as more interesting to consumers, with fibers and adaptogens close behind.”

As consumers continue to embrace chocolate, so too should manufacturers, who can take advantage of its versatility to leverage current market trends.

The rise of bite-sized chocolates: opportunities to grow in better-for-you segments. Luker Chocolate. October 18, 2023. Accessed October 31, 2023. 

https://www.lukerchocolate.com/en/chocolate-and-portfolio/bite-sized-chocolate-portions/

Articles

Chocolate is a versatile solution for health-conscious consumers who still want an indulgent treat. 

Sinlessly sweet: Trends in healthy chocolate

There is no shortage of stressors that hurt our quality of life and impact our interpersonal relationships. Economic uncertainty is a big one. According to a survey from the American Psychological Association (APA), 83% of U.S. adults cite inflation as a source of stress, and 57% indicated that having enough money to pay for things in the present is their main source of financial stress.

 According to this same survey, 27% of adults say the stress they experience makes them unable to function. Of these, 46% of them are under the age of 35. Seventy-six percent have even said their stress has impacted their health, resulting in headache (38%), fatigue (35%), feeling nervous or anxious (34%), and/or feeling depressed or sad (33%).

A study published in 2020 found that rates of anxiety have been growing since 2008, particularly among younger people.

 According to the study, which uses data from the National Survey on Drug Use and Health (NSDUH), the prevalence of anxiety increased from 5.12% in 2008 to 6.68% in 2018. For respondents between the ages of 18 and 25, the prevalence of anxiety rose from 7.97% to 14.66%, a more rapid increase compared to respondents 26-34 and 35-49 years old.

While serious mental health issues should be addressed by health professionals, many people do feel that changes in lifestyle and diet can have a positive impact on their mental health. According to the Healthy Minds Monthly poll from the American Psychiatric Association, 80% of adults between the ages of 18 and 34 said they felt very or somewhat knowledgeable about the relationship between diet and mental health.

 When asked whether they changed their diets, 66% said they drank more water, 50% said they were eating more fruits, 53% said they were eating more vegetables, 36% said they were avoiding processed food, 28% reduced alcohol consumption, and 25% said they were eating more whole grains. Another poll taken ahead of the start of 2023 found that people were making resolutions to make changes that positively impact their mental health.

 These included exercising more, meditating, taking a break from social media, and seeing a mental health professional.

Clearly, stress is having a negative impact on people’s lives, and they want to do something about it. While reducing stress in one’s life requires a variety of lifestyle interventions such as exercise and changing one’s diet, dietary supplements can be one way to address the stress in our lives. According to a recent survey of 3,192 U.S. adults from the Council for Responsible Nutrition (CRN; Washington, DC), 74% of consumers report taking dietary supplements, and 92% agree that taking dietary supplements is essential for maintaining one’s health.

When it comes to stress, botanicals offer a diverse range of ingredient solutions, and market research suggests that consumers are actively buying herbal supplements. According to 

 retail sales of herbal supplements totaled an estimated $12.350 billion, a 9.7% increase in total sales compared to the previous year.

 this was the second strongest increase in sales growth behind a record-breaking 17.3% increase in 2020 from 2019.

The Herb Market Report states that the ingredient with the greatest amount of sales growth (225.9%) that year in the mainstream multioutlet channel was the herb ashwagandha 

 Sales have slowed down in subsequent years, but the surge demonstrated a renewed interest in an established herb as awareness grows about its stress-support benefits.

 Ashwagandha is classified as an adaptogen. This class of ingredients is known to support the body’s ability to adapt to stressors, physical and psychological, making these ingredients popular for use in products across multiple categories, including sports nutrition and cognitive health.

Research has found that in both animal and human trials, ashwagandha has been able to significantly reduce biomarkers and symptoms of stress. One way the herb can impact stress is through attenuating the increase of glucocorticoids cortisol and corticosterone.

 These are the major stress hormones of humans and rodents, respectively, that are elevated during periods of stress and play. Ashwagandha may also mitigate stress through the modulation of the immune system. Animal models have shown that ashwagandha may stimulate the immune system and reduce inflammation, reducing immune and inflammatory biomarkers that were otherwise increased during stressful stimuli.

Another promising adaptogenic herb that may offer support for stress and mood is bacopa 

This herb may be better associated with cognitive health, but a growing body of evidence suggests it may benefit stress and mood as well. Based on data from SPINS from the 52 weeks ending October 30, 2022, bacopa is among the top-selling herbs in the cognitive health category in both the natural and mainstream multioutlet channels, growing in sales by 20% and 10.6%, respectively, compared to the previous year. Preclinical research shows that bacopa may have neuroprotective properties. For example, a rodent study found that in rats exposed to chronic and unpredictable stress conditions, the herb was associated with the upregulation of brain-derived neurotrophic factor (BDNF) as well as the receptor TrkB signaling pathway to activate cAMP response element-binding protein (CREB), resulting in neurogenesis and neuroprotection.

A recent human study investigating the impacts of a branded bacopa extract found that in adults with self-reported poor sleep, those taking the extract reported improvements in emotional well-being based on a Short Form-36 Health Survey.

While more research is required to understand the herb’s impact on stress, it’s promising that consumers are already buying bacopa as a way to support their brain health. They may therefore be receptive to using it to support stress as well, or perhaps even already experiencing those benefits.

Based on preclinical data and its use in traditional medicine, holy basil, also known as tulsi, has the potential to support a wide range of health outcomes, including metabolic health, cardiovascular health, as well as neurocognition.

 As an adaptogen, much of these benefits may have to do with the herb’s inhibition of inflammatory pathways. One double-blind, placebo-controlled study evaluated the herb’s impact on stress-related symptoms over the course of six weeks.

 Results showed that subjects taking a proprietary holy basil extract saw significant reductions in stress-related symptom scores for forgetfulness, sexual problems of recent origin, frequent feeling of exhaustion, and frequent sleep problems of recent origin. Total symptoms scores were also significantly reduced in subjects taking the extracts, with the experimental group experiencing a 39% improvement in controlling general stress compared to placebo.

A more recent study, also conducted in humans, found that supplementation with a different holy basil extract over eight weeks significantly reduced Perceived Stress Scale scores by 37%, Athens Insomnia Scale scores by 48%, as well as salivary cortisol levels and salivary alpha-amylase (sAA), compared to placebo.

 According to the researchers, the reduction in sAA and salivary cortisol may indicate that holy basil may have a “buffering effect” in response to acute stressors on the sympathoadrenal medullary system (SAM) and hypothalamus-pituitary-adrenal (HPA) axis, respectively.

 has been gaining traction in the sports nutrition category, supporting physical endurance and recovery. That said, our minds require some endurance as well. A randomized, double-blind, placebo-controlled, parallel-group study found that supplementation with a proprietary rhodiola extract helped improve symptoms of stress-related fatigue.

 In the study, 60 subjects between the ages of 20 and 55 were given either the extract or placebo daily for 28 days. Results showed that compared to placebo, subjects taking the rhodiola extract saw significant improvements in fatigue, based on Pines’ Burnout Scale scores, and attention, based on indices of the Conners’ Computerized Continuous Performance Test II. Subjects taking the extract also saw significant changes in their cortisol response to awakening stressors compared to placebo.

A more recent open-label study saw similar results in subjects with burnout, justifying further research investigating the herb for this purpose.

 In that study, 118 subjects with comparable stress burdens such as caring for a handicapped or elderly family member with dementia, and suffering from burnout symptoms, were administered a daily dose of a branded rhodiola extract for 12 weeks. Results showed that subjects experienced a significant improvement in the Numerical Analogue Scales (NAS) of subjective stress symptoms, including anxiety, exhaustion, feeling of heteronomy, impairment of concentration, irritability, loss of zest for life, and somatic symptoms. The greatest improvements were in the first week but continued until 12 weeks. The most obvious changes were in exhaustion, impaired concentration, and somatic symptoms. All subscores of the Perceived Stress Questionnaire (PSQ) also significantly improved, with the greatest changes at 12 weeks for the subscores of lack of joy, tension, and fatigue. For Burnout Screening Scales (BOSS I and BOSS II), global scores and all subscales saw improvements at week 8 to week 12 for subjects taking the rhodiola extract.

One potential mechanism for the herb’s stress-support benefits is the activation of heat shock protein 70, which is a stress-sensor protein that inhibits the expression of the NO synthase II gene to reduce nitric oxide (NO) production. It also interacts with glucocorticoid receptors to affect levels of circulating cortisol.

The researchers explain that preventing a stress-induced increase in NO, and the associated decrease in ATP production, can result in an increase of performance and endurance. Additionally, rhodiola may also interact with the HPA axis to limit the release of glucocorticoids.

Another promising ingredient for stress support is saffron extract, produced from the dried stigma of 

 L., which is a perennial herb member of the Iris family.

 A recent randomized, placebo-controlled, double-blind, parallel group design study found that a proprietary saffron extract was able to reduce subclinical depressive symptoms and increase resilience to stressors. In the study, 56 healthy subjects between the ages of 18 and 54 were given either the saffron extract or placebo for eight weeks. Researchers assessed the extract’s effects on subjective anxiety, stress, and depressive feelings with a battery of questionnaires, as well as acute effects in response to laboratory-based psycho-social stressors.

Results showed that subjects taking the saffron extract saw a significant reduction in Profile of Mood State-2 (POMS) Depressive subscales, but no significant difference was seen in the score for POMS Total Mood Disturbance. They also saw a significant improvement in the social relationships domain of the World Health Organization (WHO) Quality of Life survey. Compared to placebo, subjects taking the saffron extract also had higher social relationship scores 56 days post-supplementation. When it came to the response to acute stressors, subjects taking the saffron extract experienced no change in heart rate variability. This is significant because the placebo group experienced a reduction in heart rate variability, which is a sign of stress being experienced. For example, when the autonomic nervous system activates the fight or flight response, it increases heart rate, reducing heart rate variability.

The researchers say that saffron may act on similar neurotransmitter systems as pharmacological treatments of depression, and the effects saffron has on heart rate variability in response to stressors may be attributed to activity in the parasympathetic nervous system (a part of the autonomic nervous system). The extract may also act on GABAergic systems, the researchers explained.

Fact is, the world is a stressful place, and consumers are looking for ways to reduce their stress and improve their quality of life. They are already receptive to herbal supplements as a means to support a number of health outcomes, and stress is no different. The body of research on herbs and their ability to support stress is promising and continues to grow.

American Psychological Association. Stress in America 2022: Concerned for the future, beset by inflation. October 2022. Accessed October 9, 2023. 

https://www.apa.org/news/press/releases/stress/2022/concerned-future-inflation

Goodwin, R. D.; Weinberger, A. H.; Kim, J. H.; Wu, M.; Galea, S. Trends in anxiety among adults in the United States, 2008-2018: rapid increases among young adults. 

American Psychiatric Association. Four in five Americans would change their diets to improve mental health, but they rate other life factors as more impactful. April 11, 2023. Accessed October 10, 2023. 

https://www.psychiatry.org/News-room/News-Releases/APA-Poll-Diet-and-Mental-Health

American Psychiatric Association. Americans anticipate higher stress at the start of 2023 and grade their mental health worse. December 21, 2022. Accessed October 10, 2023. 

https://www.psychiatry.org/news-room/news-releases/americans-anticipate-higher-stress-at-the-start-of

Krawiec, S. Latest CRN consumer survey finds that three quarters of Americans take dietary supplements. 

. October 6, 2023. Accessed October 10, 2023. 

https://www.nutritionaloutlook.com/view/latest-crn-consumer-survey-finds-that-three-quarters-of-americans-take-dietary-supplements

Smith, T.; Resetar, H.; Morton, C. U.S. sales of herbal supplements increase by 9.7% in 2021. 

https://www.herbalgram.org/resources/herbalgram/issues/136/table-of-contents/hg136-feat-hmr/

Grebow, J. Ashwagandha’s sales growth slows down: 2023 Ingredient trends for food, drinks, dietary supplements, and natural products. 

. January 23, 2023. Accessed October 11, 2023. 

https://www.nutritionaloutlook.com/view/ashwagandha-s-sales-growth-slows-down-2023-ingredient-trends-for-food-drinks-dietary-supplements-and-natural-products

Speers, A. B.; Cabey, K. A.; Soumyanath, A.; Wright, K. M. Effects of 

 (ashwagandha) on stress and the stress-related neuropsychiatric disorders anxiety, depression, and insomnia. 

Brimson, J. M.; Brimson, S.; Prasanth, M. I.; Thitilertdecha, P.; Malar, D. S.; Tencomnao, T. The effectiveness of 

 (Linn.) Wettst. as a nootropic, neuroprotective, or antidepressant supplement: analysis of the available clinical data. 

Kumar, S.; Mondal, A. C. Neuroprotective, neurotrophic and anti-oxidative role of 

 on CUS induced model of depression in rat. 

Lopresti, A. L.; Smith, S. J.; Ali, S.; Metse, A. P.; Kalns, J.; Drummond, P. D. Effects of a 

 extract (Bacognize) on stress, fatigue, quality of life and sleep in adults with self-reported poor sleep: a randomised, double-blind, placebo-controlled study. 

Jamshidi, N.; Cohen, M. M. The clinical efficacy and safety of tulsi in humans: a systematic review of the literature. 

Saxena, R. C.; Signh, R.; Kumar, P.; Megi, M. P. S.; Saxena, V. S.; Geetharani, P.; Allan, J. J.; Venkateshwarlu, K. Efficacy of an extract of 

 (OciBest) in the management of general stress: a double-blind, placebo-controlled study. 

Lopresti, A. L.; Smith, S. J.; Metse, A. P.; Drummond, P. D. A randomized, double-blind, placebo-controlled trial investigating the effects of an 

 (holy basil) extract (HolixerTM) on stress, mood, and sleep in adults experiencing stress. 

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Olsson, E. M.; Schéele, B.; Panossian, A. G. A randomised, double-blind, placebo-controlled, parallel-group study of the standardized extract shr-5 of the roots of 

in the treatment of subjects with stress-related fatigue. 

Kasper, S.; Dienel, A. Multicenter, open-label, exploratory clinical trial with 

 extract in patients suffering from burnout symptoms. 

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Panossian, A.; Wikman, G.; Sarris, J. Rosenroot (

): traditional use, chemical composition, pharmacology and clinical efficacy. 

Jackson, P. A.; Forster, J.; Khan, J.; et al. Effects of saffron extract supplementation on mood, well-being, and response to a psychosocial stressor in healthy adults: a randomized, double-blind, parallel group, clinical trial. 

Brennan, D. What is heart rate variability? 

. April 12, 2021. Accessed October 20, 2023. 

https://www.webmd.com/heart/what-is-heart-rate-variability

Consumers are actively trying to manage their stress in the face of economic and global instability. Herbal supplements may be an intervention they’re looking for.

In the growing stress-relief category, herbs and botanicals offer a diverse range of ingredient solutions

The Federal Trade Commission is eyeing an update of its Green Guides, having sought public comment in December 2022 on a variety of potential changes to its guides on the use of environmental claims. This is the fourth time the Green Guides have been revised since their introduction in 1992, and the revision was prompted by a growing consumer consciousness around sustainability.

While the Green Guides are still under review, public comments on the guides closed in April 2023.

 It can thus be expected that the Green Guides update is close. Here are just some of the changes that experts say we can expect from a revised Green Guides.

While the contents of the final rule aren’t yet known, experts say we can expect new standards for “recyclable” claims. FTC seems particularly interested in recyclability, says Robert Marriott, director of regulatory affairs at the American Herbal Products Association (Silver Spring, MD). At present, marketers can make unqualified “recyclable” claims when recycling facilities are available to 60% of consumers where the product is sold, Marriott explains. Now, though, FTC is considering whether these products are actually recycled.

“The agency is also considering changes to its ‘compostable’ and ‘degradable’ claims, among others,” Marriott notes. “This has opened the door to new guidance on ‘organic’ and ‘sustainable’ claims.”

Dietary supplement companies should review their current label claims to ensure they know the practical recycling capacity of products labeled as recyclable, Marriott cautions. Similarly, brands making “degradable” or “compostable” claims should maintain documentation of how their products deteriorate, particularly with respect to any special conditions that products may require to break down, he says. If any such special conditions apply, they should be conspicuously disclosed in any label claims.

“Companies selling in the state of California should also pay close attention to the ongoing enactment of SB 343, a law setting standards for which products can be labeled as recyclable,” Marriott adds. “State programs like the one in California are likely to have a significant influence on the federal rule when it is finalized.”

FTC, in seeking public comment for the updated Green Guides, requested information from companies relating to a variety of specific claims in the environmental category. These claims relate specifically to climate-friendly statements, according to attorney Justin Prochnow of Greenberg Traurig LLP (Denver, CO).

“In particular, claims about carbon offsets and recyclability are the areas that will almost certainly include new or additional criteria for making claims,” Prochnow says. “This additional inquiry from FTC likely reflects the agency’s perception that there has been an increase in such claims made in advertising, as well as potential for consumer confusion.”

Prochnow notes that a variety of other “green” claims are also in FTC’s crosshairs. Claims like “ozone friendly,” “degradable,” and “recycled content” are likely to receive additional scrutiny.

The best strategy for responding to the new Green Guides, Prochnow says, is to be as specific as possible in any kind of environmental advertising you do. FTC now takes the position that green claims are unqualified claims, which means those claims are very hard to substantiate, he explains.

“Plaintiffs’ lawyers have followed suit with frequent litigation over ‘recyclable’ claims in particular,” Prochnow says. “This has been especially true of the mini-coffee brew-at-home cup category, where the small cups are often not recyclable in all recycling facilities.”

While no specific law mandates recyclability disclosures, Prochnow says the risk of class action lawsuits dictates that companies should provide such recyclability disclosures in order to avoid expensive litigation. It’s almost certain that any revisions to the Green Guides will reinforce the notion that unqualified environmental claims can be misleading, he says; thus, claims should be appropriately qualified in order to avoid confusing consumers.

The potential upcoming revisions to FTC’s Green Guides pose potential legal risks for brands and marketers. With new standards for recyclability claims, additional criteria around carbon offset claims, and an increased focus on substantiation, brands should invest in marketing audits to ensure their advertising is compliant with the new Green Guides. While the Green Guides are still under review by the agency, brands should act now to prepare for the likely changes—or risk being caught flat-footed.

FTC seeks public comment on potential updates to its “Green Guides” for the use of environmental marketing claims. News release. Federal Trade Commission. December 14, 2022. 

https://www.ftc.gov/news-events/news/press-releases/2022/12/ftc-seeks-public-comment-potential-updates-its-green-guides-use-environmental-marketing-claims

Proposed rule: Guides for the use of environmental marketing claims. December 20, 2022. 

https://www.federalregister.gov/documents/2022/12/20/2022-27558/guides-for-the-use-of-environmental-marketing-claims

Here’s what brands can likely expect from an updated Green Guides.

The FTC might revise its Green Guides. Here’s what you need to know.

Nutrition research has advanced tremendously in the last 50 years. But is the state of the science good enough yet to provide ironclad health recommendations that will actually optimize public health, including the effects of dietary supplementation?

This question was posed at this year’s “

” conference hosted by the Council for Responsible Nutrition (CRN; Washington, DC) in Dana Point, CA, on October 3. In honor of the supplement trade association’s 50

anniversary, the theme of this year’s annual scientific conference examined how far nutrition and supplement research has come, and where it still needs to go.

From Disease Prevention to Optimal Health

A century ago, nutrition scientists were primarily focused on solving micronutrient deficiencies to prevent diseases like goiter (with supplemental iodine), rickets (with vitamin D), and, later, neural tube defects (with folic acid), pointed out “Science in Session” speaker Jeffrey Blumberg, PhD, research professor at the Friedman School of Nutrition Science and Policy at Tufts University. These scientists learned that supplementing diets deficient in these nutrients could help prevent certain diseases. By the 1950s, the notion of eating fortified foods, or even taking supplement pills (beginning with yeast tablets and cod liver oil), became widespread, Blumberg explained. At the same time, policymakers sought to take this information to make public health recommendations, giving birth to concepts such as recommended dietary allowances (RDAs) and dietary reference intakes (DRIs) in the U.S.

Researchers also began establishing a hierarchy of scientific evidence with the goal that dietary recommendations would be based on rigorous scientific evidence, with the weakest types of evidence (expert opinions, case reports, animal studies, etc.) at the bottom of the hierarchy. “This was the basis of evidence-based medicine,” Blumberg said. Meanwhile, the toolbox also expanded thanks to advances in genomics, nutritional biochemistry, molecular nutrition, computing power, and statistical modeling.

Fast forward to today, and widespread diseases resulting from micronutrient deficiencies have largely been eradicated in the U.S. Today, the focus for Americans isn’t eradicating disease but rather 

public health. In this vein, researchers and policymakers still seek to use scientific evidence to make nutrient intake recommendations.

But how robust and reliable is that science today? To be sure, many gains have been made in the past century, pointed out “Science in Session” speaker Paul Coates, former director of the Office of Dietary Supplements (ODS) at the National Institutes of Health (NIH) and currently adjunct professor at the School of Public Health at Indiana University Bloomington. For instance, U.S. government agencies like NIH, ODS, FDA, USDA, and the National Institute of Standards and Technology (NIST) have worked together over decades to develop analytical methods and reference materials that have helped improve the scientific tools for designing and conducting nutrition studies.

For ODS, Coates added, the push for more robust research on the safety and efficacy of supplements stemmed from public health concerns, such as the concerns over ephedra products back in 1999. Back then, he said, most of the evidence of the effects of ephedra’s effects was largely anecdotal, and there were suggestions that ephedra could be harmful. During this time, Congress directed ODS to study the impact and risks of ephedra, and ODS began working with other agencies to develop analytical methods and reference materials to better do so.

“We learned the strategy for evaluating evidence—all of the evidence—related to the health effects of dietary interventions, including both interventional and observational data,” Coates said. He added that in later years, ODS would go on to apply this scientific rigor to evaluating the effects of other kinds of nutrients, including omega-3 fatty acids, B and D vitamins, and calcium. When it came time to study vitamin D, for instance, scientists addressed the current “unreliable array of methods for the measurement of vitamin D status in populations,” he explained. ODS created a vitamin D standardization program and collaborated with governments from other countries to build better methods. This “resulted in a standardization of the way we think about the measurement of vitamin D status,” he said.

“It gave us the confidence to be able to say, ‘We need to evaluate all of the evidence to effectively inform research public policy and health practices,’” said Coates, who headed ODS for 19 years. It also empowered FDA regulators to “clamp down” on ingredients of concern, such as ephedra.

Agencies and researchers are now better equipped with tools to measure nutrient status in the public and to study the potential benefits of supplements. This has led to the development of some public health recommendations. “I think the most important thing that ODS evolved itself to do is how do we translate the results of research for policymakers, for clinicians, and especially for the public,” Coates said.

Unsurprisingly, more research is needed. “There’s still a paucity of evidence regarding the health effects of not all, but some, supplements," he said. "There’s still not much progress on updating the dietary supplement reference intakes for most vitamins and minerals, something that I find challenging.”

Another problem? “Research funding for dietary supplements is still an issue,” he said. “Only a minority of companies are willing or able to invest in research…Federal funding is still meager compared to the other research priorities. Unfortunately, that’s also true for most of nutrition science. It’s paltry compared to the amount of money spent on the purchase of dietary supplement products by the U.S. public.”

The early days of nutrition research led to some broad public health recommendations, such as the EARs, which address the health needs of an average population. “We’re really interested in averages and apply standard deviation and covering 97% or 98% of the population,” Blumberg explained.

But among those average recommendations, a campaign for personalized nutrition is growing. The thought is that dietary and supplementation recommendations must take into account individualized nutrient status and health needs, which differ between individuals depending on genetics, lifestyle, and environment.

Are today’s nutrition research and scientific tools reliable enough to make accurate health recommendations for the public, let alone for individuals?

Most of the “Science in Session” speakers agreed that we still have a long way to go in this quest. At the forefront is a need for better biomarkers. Without determining the right biomarkers to measure, and the reliability and significance of those biomarkers, we can’t properly measure individuals’ nutrient status, nor can we judge the effects of interventions in clinical trials and come out with solid outcomes, no matter what other tools we have at our disposal.

“We have to be very thoughtful about this,” said Blumberg during a panel discussion. “I see too many people saying, ‘Let’s just throw all these bricks in a pile, and AI machine learning will give us the answer.' But I think the old phrase is, ‘Garbage in, garbage out.’ If you’re not really thoughtful about picking which biomarkers you’re going to use, and knowing that you can measure them reliably, you just end up with a mess. AI is not going to solve that problem for you.”

Understanding the complexity of diets is also a challenge whether you’re designing studies or picking biomarkers, said “Science in Session” speaker Regan Bailey, associate director of the Precision Nutrition Institute for Advancing Health Through Agriculture and a professor of nutrition at Texas A&M University. Nutrition science must take into account all of the factors that can impact nutrition status and health, including what an individual eats and whether there are “substitution effects,” “synergies,” or “antagonism,” Bailey said.

“With diet,” she said, “it’s really complicated.” She continued: “What I’m saying is that we can’t just look at one nutrient and one outcome. We have to look at all dietary exposures together.”

She emphasized the need to establish “some kind of integrated biomarker of nutritional exposures that we can then tie to what we’re 

“I think there have been tremendous advances,” she added, “but we need to come up with a way to look at nutrition status as a whole. If something is high, something else is probably low, and so looking at the constellation of markers, particularly that status rather than the one in isolation, [is important].”

Better biomarkers will result in better data, the panelists pointed out. Without them, we can’t properly advise the public on what they should eat and how they should supplement to maintain optimal health. As of now, Blumberg said, “I don’t think we’re adequately collecting the data that we really need…and so it’s really hard to be consistent, maintain programs and funding…”

This need is also on the radar of the government agencies that fund nutrition research. “Science in Session” speaker Wendy Weber, branch chief of Clinical Research in Complementary and Integrative Health Branch, Division of Extramural Research at NIH’s National Center for Complementary and Integrative Health (NCCIM), said that when NCCIM decides on which studies to fund, the agency’s goal is now “whole-person health and whole-person research.” She explained that NCCIM is not only looking at how various methods and technologies can be used in concert to study health; the agency is also looking at how it studies health, period.

“A lot of these factors—the psychological, nutritional, the physical aspects of this—often go together, and we’re very interested in this idea of multicomponent interventions,” Weber said. “It’s not just one thing. There’s not one magical answer.”

Weber added that one of NCCIM’s priorities today is also funding research on “those earlier building blocks,” meaning the foundational study tools and earlier-stage research studies that can lay the groundwork for larger studies. Previously, she said, “a lot of those earlier steps were missed before we jumped into those largely trials…”

The agency is also prioritizing reliable biomarkers as one of the early building blocks. Weber described these as “reproducible biological signatures.”

Until we strengthen nutrition science tools, we can’t make more advanced recommendations for public and personalized health. And we see resulting confusion today, including conflicting information in the public and the media about what to eat and what not to eat. Bailey said that “it’s really hard for consumers to get behind what kind of advice they should have.”

“We really need to take a break and do good science,” she added.

If personalized nutrition is to become the next step in public and personal healthcare, we need to make sure we’re laying a strong groundwork for the science. “We have these public health recommendations,” Bailey said. “Precision nutrition is really that interface. We know if we can identify people who are going to respond to the same way to a diet, then we can make actual recommendations towards reducing that risk for primary and for secondary prevention.”

Blumberg concluded: “Now is the time to pause. Now is the time to admit that we know next to nothing about how we implement precision nutrition…”

Nutrition research has advanced in 50 years. But is it good enough to make solid dietary supplement recommendations for public health today? CRN’s “Science in Session” addressed the need for better biomarkers and a holistic approach.

Is nutrition science reliable enough to make solid public and personalized health recommendations?

When the Agriculture Improvement Act of 2018—a.k.a. the 2018 Farm Bill—effectively legalized hemp-derived cannabidiol (CBD), it planted the seeds of what would soon sprout into a robust field of functional foods and supplements designed to deliver the cannabis plant’s health-and-wellness benefits.

 do was clarify which of hemp’s constituent cannabinoids 

 CBD are fair game for food, drink, and supplement formulation.

So when one cannabinoid in particular—delta-8 THC—started appearing in everything from gummies to baked goods, 

 when adverse events involving those products swiftly followed, the compound caught regulators’ attention, for all the wrong reasons.

It caught industry’s attention, too. For while fly-by-night manufacturers happy to play fast-and-loose with cannabis law may not think twice about the harm that suspicious cannabinoids can inflict on both consumers’ health and their own reputations, reputable brands 

. And they’re looking to regulators for guidance on how to proceed.

Chemically speaking, delta-8 tetrahydrocannabinol is an isomer of the delta-9 THC that gets the credit—or blame—for producing cannabis’s psychoactive effects. And though delta-8 THC occurs naturally in the cannabis plant at levels so low as to be insignificant, it, too, is psychoactive.

Granted, delta-8 THC produces a markedly less-potent intoxication than does delta-9; nevertheless, notes Shawn Hauser, partner, Vicente LLP (Denver), and co-chair of the firm’s hemp and cannabinoids department, “As with delta-9 THC, consumers enjoy the psychoactive, intoxicating, and sometimes stress-relieving effects of delta-8, and many enjoy the ‘milder’ high.”

Thus those same consumers—in contravention of what Hauser describes as “outdated laws criminalizing marijuana and denying consumers safe access to marijuana products”—have fueled what appears to be a burgeoning market for delta-8 THC and other hemp-derived intoxicants.

And while the size of that market defies precise determination “given the complex regulatory framework” surrounding cannabis-product sales, Hauser says, she points to a 

report indicating that in 2023 alone, delta-8 THC has already generated $2 billion in revenue.

That makes delta-8 THC a potentially serious business—in more ways than one. After all, says Ashish R. Talati, partner, Amin Talati Wasserman (Chicago), despite popular demand for the cannabinoid, “The legality of delta-8 THC under controlled-substances laws remains an open question.”

It all goes back to the 2018 Farm Bill, which defines legal hemp as “the plant 

. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 [THC] concentration of not more than 0.3% on a dry weight basis.”

While that spells out limits for the delta-9 isomer, it stays mum on delta-8. Moreover, a Drug Enforcement Administration (DEA) interim final rule issued in 2020 clarifies that 

 synthetically derived THC—even if synthesized from natural precursors such as hemp-derived CBD—qualifies as a Schedule I controlled substance. And as Hauser points out, most commercial delta-8 THC is synthetically derived.

“DEA has declined to significantly enforce this position and instead has largely deferred to states in regulating delta-8 and other cannabinoids,” she notes. And while she and others expect the 2023 Farm Bill to further clarify synthetic cannabinoids’ regulatory standing, “Given USDA’s jurisdictional limitations,” she says, “it’s uncertain whether and to what extent such will be addressed.”

And that’s just DEA’s position; other regulators have strong feelings about delta-8 THC, too. For example, Talati notes, “While delta-8 THC’s legal status is somewhat grey under the controlled-substances laws, it’s more black and white when it comes to FDA.”

Specifically, FDA currently considers delta-8 THC a “food additive” when formulated into a conventional food or beverage product. But FDA also deems any food additive to be prima-facie unsafe unless the agency has approved it for its intended use prior to its being marketed in a product. So by that logic, Talati explains, “Since delta-8 THC is not approved for use in any conventional food, foods containing it are considered adulterated by the FDA.”

And that brings us back to those adverse-event reports.

“With consumers demanding cannabis products, but with many not having access to marijuana in many states,” Hauser notes, “delta-8 is showing up in products in all forms of retail venues—gas stations, convenience stores, vape shops, dispensaries—as well as online.”

And as FDA reported in a consumer update titled “5 Things to Know About Delta-8 Tetrahydrocannabinol—Delta-8 THC,” the agency fielded 104 adverse-event reports in patients who ingested delta-8 THC products between December 1, 2020, and February 28, 2022, 55% of which required intervention or hospital admission, and 66% of which involved delta-8 THC delivered via food.

The reason these products are apparently causing such harm, speculation goes, owes to the extraction process used to create most commercial delta-8 THC—a process that Hauser says “poses substantial consumer risk unless producers comply with certain safety standards.”

As Hauser explains, these aren’t the typical extraction and isolation methods used to produce garden-variety CBD, as they involve “complex and advanced chemistry more akin to the creation of pharmaceutical active ingredients.”

Thus, she continues, “For legitimate public-safety reasons, the production of these ingredients requires significant controls and characterization of safety and toxicological risks, including compliance with cGMPs. State regulatory agencies are ill-equipped to regulate production at this level, and a limited number of products in the industry currently comply with these standards.”

Another safety risk on FDA’s radar involves the slipshod label declarations on delta-8 THC products—declarations that not only “likely expose consumers to much higher levels of the substance than are naturally occurring in hemp cannabis raw extracts,” the agency’s consumer guidance warns, but that likely 

 expose those consumers to higher levels of delta-8 THC than the labels actually declare.

As Hauser says, “Consumers should be aware that the majority of delta-8 products on the market have labeling that misstates the amount of THC” and that may not disclose the presence of unidentified compounds also possibly involved in adverse events—oversights that she believes “reflect that safety concerns can arise from the unregulated and unsafe manufacturing of products with these synthetics.”

And while brands that get popped for formulating with such ingredients risk civil and criminal penalties for violating both FDA and FTC regulations “as well as applicable state laws” and product-liability suits, Hauser believes that a more rational system would head off such violations before they happen.

So if she wrote the laws, “All cannabis, hemp, and marijuana would be legal for medical and adult use, and subject to reasonable product-safety regulations at the federal level,” she says.

Short of that, she continues, “I think delta-8 THC highlights the need for a modernized regulatory structure for foods and dietary supplements at the federal level, as it challenges the legal and functional integrity of the current framework and of FDA’s resources to enforce it—which framework many argue is outdated anyway and must be modernized to fulfill its intent in ensuring consumer safety.”

And that job, she notes, falls to lawmakers. “While FDA has exercised minimal enforcement and issued consumer advisories highlighting the illegality of delta-8 THC under the Federal Food, Drug, and Cosmetic Act, as well as its public-safety concerns, it has limited resources and has been clear that it believes Congress needs to develop a new regulatory framework to regulate hemp-derived cannabinoids.”

She advocates for a scientific and data-driven approach, especially in light of the legitimate safety concerns surrounding novel synthetic cannabinoids. And the good news? “Reasonable, commonsense frameworks and solutions already exist in established standards and regulations to address how to ensure products are evaluated and regulated to keep consumers safe,” she concludes. “Without such standards, we risk consumer safety, as well as industry’s advancement and credibility. It’s important that the hemp and cannabis industries work together, with a focus on product and consumer safety, to achieve federal and state reforms.”

Sabaghi, D. Delta-8 THC generated $2 billion in revenue in two years, report finds. 

https://www.forbes.com/sites/dariosabaghi/2023/01/16/delta-8-thc-generated-2-billion-in-revenue-in-2-years-report-finds/?sh=3da77fbe4a62

FDA. 5 things to know about delta-8 tetrahydrocannabinol–Delta-8 THC. Updated May 4, 2022. 

https://www.fda.gov/consumers/consumer-updates/5-things-know-about-delta-8-tetrahydrocannabinol-delta-8-thc#:~:text=66%25%20described%20adverse%20events%20after,confusion%2C%20and%20loss%20of%20consciousness

The spotlight on delta-8 THC is heating up. Where will regulators ultimately land in regard to this controversial cannabinoid?

Crazy 8s: Does delta-8 THC threaten the supplement industry?

Demand for organic supplements is soaring. One market report by Transparency Market Research expects the organic sports supplement market alone to reach a $3.7 billion valuation by 2031.

 As more consumers reach for organic products overall, demand for certified-organic supplements will only grow.

Consumers aren’t just scrutinizing ingredients anymore; they’re now looking for fully organic supplements, from excipients to fillers. Given the options on the market today, is creating certified-organic supplements easy or difficult?

Formulating Organic Supplements Isn’t Easy

While there exists considerable consumer demand for organic supplements, formulators can still find it challenging to source the necessary materials. Saumil Maheshvari, senior vice president of business development for organic-ingredients supplier Orgenetics (Los Angeles, CA), says there’s a supply shortage of certified-organic botanicals.

Not only that, other complex market factors may influence access to organic materials. For instance, Maheshvari says, “We need to balance the need for some of these organic botanicals for food or culinary aspects versus the supplement industry. And with extracts, we need more botanicals per kilogram of extract as compared to what’s needed for food.”

While it is challenging to acquire the necessary raw materials, Maheshvari says more supply is coming online every year. There are also more production efficiencies being discovered all the time as more farmers learn organic practices.

Another complicating factor that hinders organic supplement development is that for some ingredients, there simply aren’t any organic options available. Silvi Siddhu, global director, nutraceuticals, for Univar Solutions (Downers Grove, IL), says that it’s easier to obtain 95%-organic ingredients than it is to obtain 100%-organic ingredients.

What are some of the challenges and pitfalls of making certifiably organic products?

Nutritional Outlook Vol. 26 No. 9

Sinlessly sweet: Trends in healthy chocolate

In the growing stress-relief category, herbs and botanicals offer a diverse range of ingredient solutions

The FTC might revise its Green Guides. Here’s what you need to know.

Is nutrition science reliable enough to make solid public and personalized health recommendations?

Crazy 8s: Does delta-8 THC threaten the supplement industry?

Is creating certified-organic supplements difficult?

Got product reviews? What to know about FTC’s new Endorsement Guides

Asia Pacific is a promising market for plant-based meat

How does FTC’s new Health Products Compliance Guidance affect natural product companies?

Gummy supplements: So much innovation is yet to come, one expert writes