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IADSA Creates a Global Guide for Good Manufacturing Practices for Dietary Supplements

Global Regulations: IADSA Creates a Global Guide for Good Manufacturing Practices for Dietary Supplements

 and reminds us to soak in all the amazing achievements women have made to the nutraceutical space.

 is putting the spotlight on women by compiling women-related content, new and old. From research to health and wellness, women are such an important part of the nutraceutical space that 

is dedicated to covering closely. Enjoy International Women’s Day 2025!

Read more on women-led omega-3 research advances wellness for all women’s life stages.

Highlighting research on women's health and wellness, part I

In this compilation, we present recent research on menstruation and skin health. Check out studies on pain management, natural supplements for skin appearance, and even stress and sleep support.

Celebrating International Women's Day: Highlighting research on women's health and wellness, Part II

In the second part of our research spotlight, we present recent research on pregnancy and menopause.

To celebrate International Women's Day (March 8) we are highlighting articles and roundtables, produced in partnership with Women in Nutraceuticals, on women’s health research and the role of women leaders driving innovation and equity in the industry.

Stay tuned for more International Women's Day-themed content! We will be updating this landing page throughout this week.

International Women’s Day. International Women’s day 2025 campaign theme: Accelerate action 

Check out our exciting 2025 International Women's Day coverage!

Women In Nutraceuticals

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Nutritional Outlook celebrates International Women's Day 2025

OmniActive Health Technologies (Bridgewater, NJ and Mumbai, India) has announced a partnership with the Council for Responsible Nutrition (CRN; Washington, D.C.) to educate and raise awareness about the role of lutein and zeaxanthin in supporting maternal and fetal health during pregnancy among obstetricians, gynecologists, and other maternal healthcare practitioners. This knowledge will be shared at The American College of Obstetrics and Gynecology’s (ACOG) Annual Clinical & Scientific Meeting. OmniActive is 

one of six companies CRN has partnered with

 to showcase the latest research and developments in prenatal nutrition through a specially designed “Prenatal Nutrition Center” at the conference. 

“It’s wonderful to have OmniActive as one of our featured partners during the ACOG annual event to help spread the word on the importance of prenatal nutrition,” said Andrea Wong, PhD, senior vice president, Scientific & Regulatory Affairs for CRN, in a press release. “CRN continues our efforts in supporting supplement manufacturers and ingredient suppliers in bringing clinically studied products to consumers to help meet their nutritional needs. Advancing awareness at the physician’s level is a huge part of this equation and this meeting is an effective way of reaching them.”

Citing market research from SkyQuest Technology, OmniActive explains in its press release that prenatal supplement sales were estimated to be at $740 million in 2023 and projected to rise to $1.4 billion by 2031. Similarly, a recent 

 found that about 60% of gynecologists think that 80-100% of their pregnant patients take dietary supplements. There is therefore a great deal of opportunity to grow and advance this category. Lutein and zeaxanthin are known for their support of eye health, but these benefits are relevant during pregnancy as well, says Deshanie Rai, PhD, FACN, vice president of Global Science, Regulatory and Advocacy at OmniActive Health Technologies.

“Current evidence supports the preferential accumulation of lutein and zeaxanthin in the human eye and neural tissues during pregnancy, especially during the third trimester. This suggests that lutein may play a functional and protective role in infant visual and cognitive development. As part of our Lutein for Every Age campaign, our goal is to help educate healthcare practitioners on this latest nutritional science research and the benefits of achieving adequate dietary lutein during pregnancy,” said Rai, in a press release. “OmniActive is proud to partner with the CRN Foundation’s Prenatal Nutrition Centre to promote awareness among healthcare practitioners on the nutritional relevance of lutein for both mom and baby.”

The educational initiative, “Lutein for Every Age,” focuses on raising awareness of early and consistent lutein and zeaxanthin intake to help support eye, cognitive, and general health throughout life, explains OmniActive. The AOCG meeting is taking place from May 17-19, 2024 in San Francisco, CA.

OmniActive Health Technologies has announced a partnership with the Council for Responsible Nutrition to educate and raise awareness about the role of lutein and zeaxanthin in supporting maternal and fetal health during pregnancy among obstetricians, gynecologists, and other maternal healthcare practitioners. 

OmniActive partners with CRN to raise awareness about macular carotenoids for prenatal health

On March 10th, 2025, HHS Secretary Robert F. Kennedy Jr. instructed the acting FDA commissioner to explore potential rulemaking to eliminate the self-affirmed pathway for establishing a substance as Generally Recognized as Safe (GRAS). Under the current GRAS system, companies can independently determine that a substance is safe for use in food without requiring formal FDA approval, as long as there is consensus among qualified experts. Eliminating this pathway would require companies to notify the FDA before marketing substances as GRAS—a rule that the FDA has previously acknowledged exceeds its statutory authority. Regardless, any attempt to change the GRAS framework is likely to face significant challenges, including strong industry resistance and resource constraints, making both rulemaking and broader legislative reform difficult to achieve. Past attempts to review all GRAS substances have proven cumbersome, and some of the most concerning substances, such as color additives, are already excluded from the self-GRAS process. Given these challenges, the FDA may be better served by focusing its efforts on identifying and banning the highest-risk substances rather than eliminating the self-GRAS pathway entirely.

The concept of GRAS dates back to the passage of the Food Additives Amendment to the FDCA (Federal Food, Drug, and Cosmetic Act) in 1958. The act gave the FDA the authority to regulate food additives to ensure they are safe for human consumption. However, recognizing that many substances used in food (example common spices, salt) had long been safely consumed, Congress created the GRAS exemption, allowing certain substances to bypass the food additive approval process.

The FDA first published a list of generally recognized as safe (GRAS) substances in the Federal Register of December 9, 1958. This list came to be called the GRAS list. The current GRAS list appears as Parts 182, 184, and 186 of the Code of Federal Regulations (CFR).

FDA Removes Cyclamate; Nixon Orders Comprehensive Review

The FDA removed cyclamate salts from the GRAS list after studies linked them to an increased risk of bladder cancer in laboratory animals. In response, President Nixon ordered the FDA to reassess the safety of all GRAS substances under modern scientific standards to ensure they remained safe.

The FDA launched a full-scale review of all presumed GRAS substances. This involved evaluating the scientific evidence supporting each substance’s safety and determining if it should retain GRAS status. The FDA introduced a petition-based process, allowing manufacturers to seek confirmation of GRAS status. However, the process was highly time-consuming, taking up to 6 years (72 months) for the FDA to respond to a single petition.

After more than a decade, the FDA determined that the petition-based GRAS review process was unsustainable. The agency stopped conducting active GRAS reviews but continued to respond to petitions on a case-by-case basis when submitted by manufacturers.

Proposed Rule for Voluntary GRAS Notification

To reduce the regulatory burden and accelerate the review process, the FDA introduced a voluntary GRAS notification program through a proposed rule.

Under this system, companies could independently determine that a substance was GRAS based on publicly available scientific evidence and the consensus of qualified experts. Companies could notify the FDA of their determination, and the FDA would evaluate the evidence. If the FDA had no questions or objections, the company could proceed with marketing the substance without waiting for formal FDA approval. The FDA took about an average of 5 months (162 days) to respond. The FDA believed this would encourage companies to notify them rather than relying solely on self-affirmation.

FDA Issues GRAS Final Rule Formalizing the Notification Procedure

The FDA issued the GRAS final rule formalizing the GRAS notification program, clarifying that GRAS status must be supported by publicly available evidence and the consensus of qualified experts. The FDA retained the right to challenge a substance’s GRAS status if new scientific evidence raised safety concerns.

However, companies could still market substances as GRAS without notifying the FDA, provided they could demonstrate expert consensus on safety.

FDA’s rulemaking authority is derived from the FDCA and other statutes enacted by Congress. The FDA has the authority to issue regulations and guidelines to implement and enforce the provisions of these laws, but its rulemaking power is limited to the scope of authority expressly granted by Congress. The FDA cannot unilaterally impose new statutory requirements, eliminate existing exemptions, or fundamentally change the intent and purpose of a statute without Congressional approval. Here, the primary question remains: would requiring FDA approval for all GRAS substances effectively dismantle the GRAS exception altogether?

This issue touches on the broader statutory authority of the FDA and the legislative intent behind the creation of the GRAS exception—an issue the FDA has previously addressed and concluded is beyond their statutory authority. During the 2016 GRAS rulemaking, some commenters urged the FDA to require companies to notify the agency when concluding that a substance is GRAS. In response, the FDA stated that it does not have “express statutory authority” to mandate GRAS notifications. The FDA explained that when Congress established the premarket approval requirement for food additives in the 1958 amendment, it deliberately excluded substances that are GRAS under their intended use from the definition of “food additive.” This exclusion reflected Congress’s determination that certain substances intentionally added to food do not need FDA premarket approval to ensure safety. The FDA, in both its 1997 proposed rulemaking and 2016 rulemaking, has acknowledged that manufacturers have been able to independently determine GRAS status without notifying the FDA, as permitted by statute. Thus, the FDA only has statutory authority to modify or clarify the criteria for determining GRAS status and the scientific basis for such determinations. Requiring FDA approval for all GRAS substances would effectively redefine “food additive” under the FDCA and close the GRAS exemption—something that would require an amendment to the FDCA.

Furthermore, Congress’s intent to maintain the GRAS exception was reinforced by the Food and Drug Administration Modernization Act (FDAMA) of 1997, which amended Section 409 of the FD&C Act to create a mandatory food-contact notification program for human food. Yet, Congress did not amend section 409 to require a mandatory premarket GRAS notification process.

To amend the FDCA and eliminate GRAS, Congress follows an extensive process that includes drafting, committee review, debate, voting, and presidential approval. Similarly, any change from the FDA will require formal rulemaking under the Administrative Procedure Act, which involves publishing a proposed rule, allowing public comments, and issuing a final rule based on feedback. Through either avenue, both the FDA and Congress would face many challenges:

Industry resistance and lobbying efforts:

Powerful lobbying groups would resist eliminating self-GRAS, citing increased costs and supply chain disruptions. This could lead to delays through political debates, legal challenges, and potential legislative actions, further hindering the FDA’s efforts to implement any such proposed rule. Furthermore, legal challenges from industry stakeholders on constitutional grounds could tie up the proposed rule in litigation for years, further delaying its implementation and possibly forcing revisions or abandonment of the proposal.

A cost-benefit analysis would be needed to weigh public health benefits against the economic burden on the food industry. Eliminating self-GRAS would increase compliance costs, testing expenses, and product development delays, particularly harming smaller companies and startups, potentially stifling innovation and consolidating market power among larger manufacturers.

Shifting safety assessments to the FDA would require more staff, funding, and scientific review capacity, leading to longer approval times, increased costs, and internal resistance due to resource constraints, undermining the FDA’s efficiency. Historical precedent, such as President Nixon’s call for a comprehensive GRAS review, shows that reviewing every GRAS substance would be burdensome given current staffing and budgetary constraints.

Executive Order 14192 and the Trump administration’s focus:

Executive Order 14192, titled “Unleashing Prosperity Through Deregulation” mandates that for every new regulation issued, federal agencies must identify and eliminate at least ten existing regulations. Eliminating self-GRAS would also contradict the current administration’s stance on reducing regulatory burdens and promoting business-friendly policies.

In an announcement video posted on X, the HHS Secretary specifically mentioned concerns over Red 40, Yellow 5, and Yellow 6 in the U.S., misclassifying them as “generally recognized as safe” (GRAS). However, color additives are not classified under GRAS, as they are all subject to FDA approval. Under the FDCA, all color additives, as well as new uses for listed color additives, must be approved by the FDA before they can be used in foods, drugs, cosmetics, or certain medical devices, or applied to the human body. There is no GRAS provision for color additives within the statutory definition. This distinction is critical, as it underscores a common misconception about the regulatory framework surrounding these substances and highlights ongoing challenges in achieving scientific consensus. Even FDA-approved substances, such as artificial colorants, may face conflicting scientific assessments as new research emerges—Red Dye No. 3, for example, was recently banned. Thus, many of the most pressing public health concerns regarding food additives, such as food dyes, cannot be resolved simply by eliminating the self-GRAS process.

State actions, such as West Virginia’s recent ban on these color additives, further complicate public discourse. States have the authority to impose stricter regulations based on their own health and safety concerns, even when substances are federally approved. While the FDA may deem these dyes safe, some states, citing studies linking the dyes to behavioral issues in children, have opted to impose bans. This creates a fragmented regulatory environment, where food manufacturers must navigate a patchwork of regulations.

The underlying scientific and regulatory conflict persists, regardless of whether self-GRAS is eliminated. The tension between state and federal regulation complicates efforts to ensure consistent and reliable food safety standards. A more effective solution may not be the elimination of self-affirmed GRAS, but rather a continuous, rigorous scientific evaluation of potentially harmful substances. This approach should include regular inspection and consistent enforcement by FDA to ensure that all substances used in food products are safe, even for those that have not been formally notified to the FDA.

At this stage, nothing has changed. The self-affirmed pathway for GRAS is far from being eliminated. Challenges related to FDA rulemaking authority, industry resistance, and resource limitations will delay any major changes to the current framework. However, companies may encounter increased litigation and heightened regulatory scrutiny, particularly for those that have self-affirmed GRAS for certain substances. To prepare for potential legal and regulatory challenges, companies that have self-affirmed GRAS status can:


Ensure that the scientific data supporting each self-affirmed GRAS substance is comprehensive, up-to-date, and robust enough to withstand legal and regulatory challenges.

Be prepared to conduct additional studies to address emerging safety concerns or evolving public health debates that could arise.

Monitor and prepare for regulatory and legal changes:

Regularly review internal processes to ensure compliance with existing regulations and proactively prepare for potential future changes to avoid disruptions and maintain customer confidence.

If you have any questions about GRAS, Food Additives, Color Additives, New Dietary Ingredient Notifications, contact Talati Law Firm PLLC at 

HHS and FDA consider major changes amid legal and industry pushback.

The GRAS system at a crossroads

As the sports nutrition category expands, more consumers—not just athletes and highly active individuals—are looking for ways benefits from these supplements can apply to everyday life. In turn, manufacturers looking to offer consumers new products have several ways to explore this expansion of the category.

As Laura Kunces, PhD, RD, CSSD, vice president of medical strategy at Thorne, explains in an interview with 

, “Everyone has a different definition of performance. It can be defined as your job you need to do, whether that is being a professional athlete or an athletic professional, or even just a general human being; there are numerous areas of overlap.” Nonathletes can benefit from performance supplements in some instances, she adds, due to health issues, changes in stages of life, genetic concerns, or gaps in diets.

Similarly, Susan Hewlings PhD, RD, co-founder of Substantiation Sciences, sees the new reach of the category as an opportunity. “This opens the door for formulating and marketing because it targets active people which can also include people who are trying or wish they were more active,” she explains. “This is in contrast to the ‘athletes’ that sports nutrition used to target. These people were more serious, more hard-core and very focused on performance and recovery. The active consumer has a broader area of interest and is trying to fit working out into their everyday responsibilities. This opens the door to many more categories, and with small changes more closely mirrors the general population but still has a sports and active vibe to the messaging.” One example Hewlings provides the is the goal of offsetting muscle loss due to aging, which is less about “gains” and more about remaining active in the long-term.

Ingredients like protein and creatine which have historically been associated with enhancing the performance of athletes can still benefit consumers with different active nutrition goals, Hewlings explains. Additionally, she points out, protein and creatine have an established record of safety. Notably, based on data from SPINS from the 52 weeks ending October 6, 2024, creatine was among the top 10 ingredients in the performance category of the mainstream multioutlet channel, with $51,573,676 in sales, a 46.5% increase from the previous year. Additionally, creatine is starting to be recognized by women as important to their unique physiology, Kunces notes.

“Ingredients rarely have one purpose,” Kunces explains. “Take collagen for example. Popular in the skin health industry, it’s a staple for athletes, but also in the aging population too. The same goes for electrolytes, creatine, fish oil, and many more nutrients that have benefits that extend beyond the field or the gym. Educating the consumer on why they need it, the research on doses and timing for their desired use cases, and meeting them with the right format (powder, capsule, etc.) is the bigger challenge.”

Nutrition and diet education can also be an important factor in supplementation choice. As a recently published 

noted, even among athletes, inadequate nutrition is occasionally replaced by supplementation as compensation. The review also noted prior studies demonstrating that protein and creatine were commonly used by athletes to enhance muscle repair and performance, with other supplements being vitamin D and vitamin C.

Carbohydrates do not necessarily get enough recognition as a sport ingredient, Hewlings suggests, as they are necessary for fuel for active people and can provide B vitamins and fiber. Vitamin D is also important not just for immunity support, but for recovery and muscle heath in extensive training. Kunces also identifies vitamin D, along with magnesium, as overlooked and that most Americans are insufficient or deficient in, while athletes may want to consider higher levels.

Kunces identifies curcumin as another ingredient for athletes and non-athletes to consider. “It helps to maintain a healthy inflammatory response in the whole body – including muscles, joints, GI tract, liver, brain, [and] nerves,” she explains. “Inflammation doesn’t have to be caused by physical exercise, as we see so many environmental, lifestyle, and dietary factors causing inflammation in the body.”

Whey protein is also becoming more in-demand, she adds. “People are recognizing the benefits of having protein at every meal to help stabilize metabolism, improve satiety, and meet nutritional needs with a convenience product,” Kunces explains. “Also, when protein is mixed with other powder nutrients like creatine, fiber, magnesium, it’s an easy way to build a personalized nutrition smoothie for anyone’s needs.”

The formulation of these kinds of products requires different considerations of consumer needs, though efficacy and compliance are the most important, Kunces explains. “High-quality, research backed, and sustainable ingredients that can then be put into the right format for user convenience while making sure it tastes good are all key pieces to the consideration puzzle.” Factors such as age group, health goals, health conditions, medications, and interactions with other formulations are also to be taken into account when formulating for certain populations.

“Match your science to your population,” Hewlings suggests. Ensure the research supports the claims for the target population and that the mechanisms of action are sensible.

Hopper, C.; Mooney, E.; Mc Cloat, A. Nutritional Intake and Dietary Knowledge of Athletes: A Scoping Review. 

Athletes and nonathletes alike can benefit from supplements that support muscles, energy, and nutrients for a variety of activities.

Formulating for everyday performance

The ingredient most synonymous with energy is caffeine. Based on data from SPINS from the 52 weeks ending October 6, 2024, caffeine was featured in the top 10 ingredients in the energy category of the natural channel, with 23.9% sales growth for a total of $2,292,775 in sales. In the performance category of the mainstream multioutlet channel, caffeine also ranks in the top ten with $22,923,614 in sales, a 3.6% increase from the previous year. Additionally, within the mainstream channel, caffeine is among the 25 top-selling functional ingredients, but did experience a 7.6% decrease in sales. Despite its importance and popularity as an energy ingredient, within the energy category of the natural channel, for example, other ingredients such as B vitamins outsell caffeine. Therefore, a successful energy product requires more than the reliable boost of caffeine as consumer seek healthier energy solutions.

 on energy drinks noted that the most prevalent ingredients out of the top 75 selling drinks in the U.S. in 2021 were caffeine, sugar, B vitamins, electrolytes, and taurine. Typically, energy is sourced from stimulants such as caffeine, though this comes with drawbacks. Anxiety, jitters, and sleep disturbances are common effects from caffeine that consumers seek to avoid, especially if their goal is increased concentration. As 

 has shown, adolescents and pregnant women are more sensitive to the effects of caffeine, which can pose dangers to health. Even long-term use of energy drinks in older adults resulted in negative cardiovascular effects.

Overall, as Susan Hewlings PhD, RD, co-founder of Substantiation Sciences explained in an interview with 

, “The term ‘energy’ needs to be carefully considered…it is most often associated with the acute ‘awakening’ you get from caffeine and other stimulants but that is not always what consumers are seeking. Many want more of a long term offset to chronic fatigue or an increased motivation or an increased focus.”

Caffeine for quick and easy energy, though common and readily accessible, may not be a suitable choice for all consumers. Alternative ingredients have been emerging with the potential to help consumers achieve their energy goals. For example, Hewlings notes that the caffeine metabolite paraxanthine is processed quickly and does not result in jitters. Additionally, theacrine is similar to caffeine, without the addictive effects.

Aside from alternatives to caffeine and stimulants as an energy source, there are alternate mechanisms of action for energy production in the body. “Part of the challenge in this space is one of identity and differentiation,” Hewlings explains. “I suggest knowing what ‘energy’ you are targeting because they have different mechanisms of action and will therefore require a different ingredient. Typically, when consumers are seeking a caffeine alternative they are seeking to avoid side effects which are very individual.”

Laura Kunces, PhD, RD, CSSD, vice president of medical strategy at Thorne, explains that deciding on an energy source may take a holistic approach for the consumer, and can involve examining diet and nutrition intake as well as overall health and goals. Deciding on a supplement goes deeper than a conventional stimulant. “Differences in energy production can be realized at the cellular, tissue, and organ levels influencing actual energy production and our perception of feeling energized,” Kunces says. “Some supplements provide direct energy in the form of calories. Examples are macronutrients like carbohydrates, fat, or protein. Some help maintain the structure and function of a cell so it can properly do its job, like DHA or iron. Some supplements can work to mitigate the underlying issue that is preventing proper energy production.”

Carbohydrates, a common dietary source of energy, for example, “provide direct energy (calories) and break down into glucose for quick entrance into the bloodstream. They can provide significant ATP for the functioning body,” explains Kunces.

Other ingredients may be effective at supporting both mental and physical energy. “Creatine is a key component of the phosphocreatine system, helping the muscles create and regenerate the energy demands for a few seconds of intense movements, from hoisting a kid to your shoulders to doing a back flip. Intense cognitive thinking requires the same energy system, so creatine also plays a role in mental energy needs during periods of high demand, like at work or driving a car,” Kunces explains.

Additionally, some supplements such as B-vitamins and the amino acid beta-alanine provide indirect energy, but help energy metabolism or delay fatigue. Vitamins B

 in particular help convert carbs, fat, and protein into usable energy. Others support the transport of oxygen through the body by maintaining red blood cell structure. Nicotinamide riboside (NR), a form of B

 and a precursor to NAD+, also supports energy production. Finally, Acetyl-L-carnitine helps with focus, and mental clarity by supporting mitochondrial energy production.

Apart from micro and macronutrients, Kunces notes a few lesser-known sources of indirect energy: the herb Greek mountain tea, Lion’s mane mushrooms, and Alpha-GPC. She says that Greek mountain tea can support mental alertness by promoting blood flow to the brain, Lion’s mane supports cognition by helping stimulate the growth of neurons, and Alpha-GPC, popular with athletes, promotes physical stamina through human growth hormone production support.

Furthermore, when combined, many of the aforementioned ingredients may complement one another to provide a greater impact on energy. “A good multivitamin that contains a B-vitamin complex, magnesium, and iron can help make sure that food is broken down for energy, ATP is biologically active, and oxygen is being transported to aid in cellular respiration in the mitochondria,” Kunces explains “NR and polyphenols like resveratrol can help increase NAD+ levels and activate sirtuins that use the NAD to improve mitochondrial efficiency and output. L-carnitine with omega-3s, and alpha-lipoic acid can help enhance fat metabolism and mitochondrial efficiency. Electrolytes with water as hydration is key to maintaining metabolic processes.”

There are various mechanisms of action through which energy can be produced. Additionally, the way energy is experienced can differ depending on its source. More considerate energy options will allow consumers to achieve their energy goals with health in mind.

Antonio, J.; Antonio, B.; Arent, SM.; Candow, DG.; Escalante, G.; Evans, C.; Forbes, S.; Fukuda, D.; Gibbons, M.; Harty, P.; et al. Common Questions and Misconceptions About Energy Drinks: What Does the Scientific Evidence Really Show? 

With sustained interest in energy, alternatives to the typical caffeine and other stimulants can offer consumers a more personalized approach with fewer side effects.

Energy alternatives to adapt to consumer needs

It used to be that there was a cold and flu season. Dropping temperatures in fall and winter would create the right conditions for viruses to proliferate. The COVID-19 pandemic has largely upended this concept since peaks in infection can happen throughout the year. Therefore, immune health as a dietary supplement category is changing; not just when people take these products, but also how they are integrated into their supplement regimen.

“[Consumer] behavior has changed since COVID in that rather than taking immune supplements acutely to address poor immune health and related conditions, they are now looking for products that support immune health as an important component of those that enhance general wellbeing,” explains Irfan Qureshi, ND, global head of product development at Metagenics. “Increasingly, consumers are equating immune health with daily wellness, and this is fantastic news for companies that promote the use of supplements as a critical part of a daily care regimen since it suggests consumers are broadly open to a proactive approach to health,”

Alice Mintz, director of brand strategy at the market research firm SPINS believes that immune health is taking a couple of different paths in the nutritional industry. While it is not the fastest growing health focus anymore, she explains, formats such as wellness shots are allowing consumers to more seamlessly integrate immune health benefits into their daily lives. Mintz also points out that zinc incorporation is one way manufacturers are infusing immune benefits into products that may not necessarily be marketed toward immune health specifically. There is also an opportunity to “refresh the familiar” as Mintz calls it.

As an example, Mintz points to the relationship between citrus products like orange juice and vitamin C, which is associated with immune health benefits. “And so now, when we...understand how there’s this connection point between fruit functionality [and health], how can you bring that narrative back in a way that is contemporary and driving home the functionality aspect,” says Mintz.

What this comes down to is ease of use. Now, more than ever, consumers want to be able to seamlessly incorporate these products into their lives, and alternative dosage formats are a great way to do this. “We continue to see increasing adoption of sensory formats, like gummies, outpacing growth for powders which used to be the first big sensory format in the need state,” says Daniel Renteira, director of innovation, MegaFood. “Another trend we saw was the increasing numbers of consumers buying multi-ingredient solutions that provided a combination of ingredients with C, D, and zinc as the mainstays in typical formulas.” These multiple ingredient solutions are also leading consumers to seek out products providing multiple benefits to meet their interests of supplementing for overall wellbeing.

Qureshi mentions that consumers are becoming more informed about ingredients for immune health, actively seeking out ingredients like vitamin C, vitamin D, and zinc. They are also focused on learning more about ingredients outside of the vitamin space in search of other options. For example, there has been an increased interest for botanicals and mushrooms due to the immune benefits they provide and are also found to be good complimentary ingredients with vitamins and minerals. These include ingredients such as elderberry, echinacea, Andrographis, 

“Immune products are increasingly featuring biotics (pro, pre, and post). Probiotics for immune health are well established in market, but postbiotics such as tributyrin & yeast fermentates have grown significantly popular recently,” says David Gunderman, PhD, principal of nutrition science at MegaFood, “Botanicals continue to proliferate with consumers and manufacturers expanding from terrestrial plant life to embrace immune-supporting algae like sea moss and bladderwrack sourced from the ocean. Such ingredients would only complement the existing immune health ingredients such as vitamins C, D and zinc as they function on distinct but complementary cellular pathways.”

“Of further note, consumers are certainly looking at products that address benefit platforms of interest to their daily experience. There is an essence of personalization that comes along with this in that consumers will gravitate towards products they feel best address their needs on a holistic level,” says Qureshi. “An example would be a multivitamin specific to a particular gender or age category that supports immune health, mood, and heart health. The more that companies can address the needs of specific segments, the greater a product will resonate with consumers and the more successful a product line is bound to be.”

There are also important synergies that exist between immune health and other health focuses. The body’s immune system is very interconnected and may be more sensitive to the overall health of the individual. “Deficits in nutrients, and sleep can negatively impact immune health,” says Gunderman. “Even stress, both physically and chemically can suppress immunity, whereas good mental health can enhance immune function. Thus, supplements that address sleep, stress or overall wellbeing may also be inadvertently supporting a healthy immune system.”

“Moreover, the role of the digestive system and its impact on immune health has garnered extra attention recently as we learn more about the link between the gut and immune function,” he adds. “A healthy gut microbiome is essential for a healthy immune system with microbes modulating inflammatory responses and promoting the production of immune cells.”

As consumers take a more holistic approach to their wellbeing, there is value in incorporating immune supportive ingredients into supplement formulations that encompass a range of benefits. There are natural synergies that exist between ingredients and health targets that can translate into innovative and effective products. Additionally, more convenient dosage formats encourage compliance with routine supplementation.The immune health space may be changing, but the need for these ingredients and products is not going away.

With a growing demand in multi-ingredient and multi-benefit formulas, manufacturers should explore synergies between ingredients and broader health categories as immune health becomes part of consumers’ daily health maintenance rather than a seasonal concern.

Sam Jennings

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