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Quality assurance, compliance, risk management, and best practices were on the minds of 80 quality professionals who convened at the Capsugel Quality Summit in late August.

At Capsugel’s Quality Summit, Experts Focus on the Way Forward for Dietary Supplement Quality Control

Capsules can improve the stability, bioavailability, and taste-masking of some of the most popular weight-management ingredients. 

How Capsules Solve Delivery Challenges of Today’s Most Popular Weight-Management Ingredients

Capsule colors enable brands to communicate and connect with consumers.

Tablet and Capsule Colors: Multifunctional Purpose

Capsule options are satisfying today’s dietary supplement formulation-and consumer-needs.

Dietary Supplements: Cutting-Edge Capsules

 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

Topic

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

are all the rage in 2025. According to Grand View Research, the global gummy market is expected to grow at 11.8% per year through to 2030, with evolving consumer preferences driving this uptick in popularity. Gummies are also expanding beyond the children’s nutrition market and into adult nutrition, with adults now representing the core consumer base for gummy supplements. With their candy-like taste and texture, gummies improve the experience of taking supplements for consumers, offering an easier-to-swallow alternative to tablets and capsules. As gummies soar in popularity, contract manufacturers are increasingly offering gummy supplements as one of the many services within their portfolios. Here are just some of the emerging trends in gummies that contract manufacturers are witnessing.

Gummy supplements are rapidly expanding into nearly every healthy category. Michelle Herrera, head of market intelligence at gummy contract manufacturer Funtrition (Miramar, FL), says consumers are increasingly interested in not only preventative nutrition, but also nutritional products that help meet nutritional requirements that cannot be met through diet. Herrera notes that gummies offer indulgence, convenience, and nutrition, and can be adapted to any category.

“We’re observing significant interest in gummy formats across several key health categories,” Herrera says. “Some trending this year include mental health and sleep, women’s health, fitness and performance, and metabolism support.”

Gummies are increasingly popular for sleep and relaxation products, Herrera says, addressing a growing need for stress management and mental well-being. Meanwhile, women’s health gummies are catering to specific needs like hair care, nail care, skincare, and reproductive health. Among active consumers, gummies are gaining traction for fitness-oriented products like hydration solutions, electrolyte products, and targeted micronutrient delivery. Finally, Herrera explains, metabolism-boosting gummies are growing as a portable and convenient way to support peak energy, cardiovascular health, and digestive balance. Meanwhile, Angie Rimel, marketing communications manager, North America, for Gelita (Sioux City, IA), says that gummy formats are also growing in sectors like vitamins and minerals, immune health, and heart health.

Rimel says that brands who are developing gummy products often seek a mix of both turnkey and custom options depending on the brand’s unique needs and market goals. Turnkey services, for instance, are particularly appealing to customers that are new to the industry and who want to launch a new product quickly. Meanwhile, established brands or brands targeting niche markets typically prefer a custom formulation.

“Custom formulations offer creative and unique products that cater to specific consumer needs or preferences,” Rimel says. “This includes flavor profiles and specific health benefits.”

Rimel says that contract manufacturers are even offering application-specific gummy solutions for brands who know exactly what they want. She points to Gelita’s branded Verisol HST as an example, which is a gelatin solution for nutricosmetic gummies that leverages bioactive collagen peptides to support skin, hair, and nail health.

In addition to custom and turnkey solutions, some contract manufacturers are also offering a middle solution. Rosella Del Vecchio, marketing director at Funtrition, says this approach enables brands to stand out without fully investing in custom development. Funtrition’s semi-custom solutions enable brands to modify key elements like flavors, ingredients, and dosages while leveraging preexisting formulations. Del Vecchio notes that a semi-custom solution is a cost-effective way to create product differentiation without the extended lead times or higher research and development costs of a fully bespoke product.

The soaring popularity of gummies is attracting new brands into the gummy space; however, these customers often come to contract manufacturers with a variety of misconceptions about gummies. Del Vecchio says that the most common misconception among brands is that gummies are “just candy with supplements added.” In reality, gummies require precise formulation and ingredient interaction to ensure stability, efficacy, and proper nutrient delivery, she explains.

Another common misconception among brands is that all gummy manufacturers are the same. Many new customers assume that any manufacturer can produce high-quality, stable gummies, however, Del Vecchio says that specific expertise is required to ensure bioavailability, shelf stability, and regulatory compliance.

“Customers also often think that customization is always better,” Del Vecchio notes. “While a unique formula may seem more appealing, it often involves longer research and development timelines, higher minimum order quantities, and additional stability testing. In many cases, leveraging proven formulations with minor modifications is a smarter go-to-market strategy.”

While gummies were originally conceived as a children’s product, gummy supplements are now mainstream and popular among consumers of all ages. That means brands need to be prepared to market gummy supplements to consumers across the entire lifespan, not just children. Rimel says brands can market to older consumers by emphasizing that gummies are easier to swallow than pills, as older consumers may have difficulty swallowing.

“Older consumers are also health-conscious and look for products with natural ingredients,” Rimel explains. “Gelatin is natural and familiar, and it combines multiple benefits and functionalities into a single ingredient.”

Critics of alternative dosage formats like gummies have often noted that traditional gummy supplements have a high sugar content. As consumers increasingly look to reduce their sugar intake, low-sugar gummy options are trending upward. Herrera says that contract manufacturers like Funtrition are leveraging innovative sweeteners to bridge the gap between taste and nutrition, offering guilt-free indulgence. This includes formulating with natural sweeteners like fibers, allulose, and stevia.

Meanwhile, contract manufacturers are introducing other low-sugar technologies that maintain taste. Gelita recently introduced its branded Soluform gelatin, an innovative gelatin that enables gummy formulations with reduced sugar content and an enriched collagen concentration. Soluform maintains gelatin’s one-of-a-kind texture while also providing an abundance of flavor.

Contract manufacturers have stepped up their gummy game in response to strong demand for tasty, low-sugar gummy options that can handle a diverse range of ingredients. With more brands choosing gummies as their preferred delivery method, gummy contract manufacturers are also introducing more flexible manufacturing options that bridge the gap between turnkey and custom solutions. As gummies continue to grow in popularity, expect contract manufacturers to offer even more diverse options to brands looking to get in on the gummy craze.

Grand View Research. “Gummy market size, share & trends analysis by product (vitamins, minerals, dietary fibers), by ingredient (gelatin, plant-based gelatin substitutes), by end-use (adults, kids), by distribution channel, by region, and segment forecasts, 2024-2030.” 

https://www.grandviewresearch.com/industry-analysis/gummy-market-report

Emerging trends in the contract manufacturing of gummy supplements.


A gaggle of gummies

Mysterious gases, dark corners teeming with strange lifeforms and tantalizing secrets that scientists spend their entire careers working to decode; are we talking about a distant alien planet, or the human digestive system? Though they represent opposite ends of the micro- to macroscopic scale, the fields of gastroenterology and astronomy have a surprising amount in common, not least their tendency to cause confusion. Just as questions persist surrounding the inner workings of outer space, many consumers remain unclear on the topic of their gut health, and how best to support it. One clear fact is that ‘good’ bacteria, or probiotics, are key to strengthening and diversifying the gut microbiome, which in turn can support our well-being.

 Holding with the comparisons to space travel, probiotics are the rocket that transports us to reduced gastric discomfort,

 but whether literal or figurative, they need the right fuel: prebiotics. These less well-known, yet equally essential cousins, act as catalysts for the beneficial bacterial strains on which our guts depend. Prebiotics officially recognized by the Scientific Association for Probiotics and Prebiotics (ISAPP) and the Global Prebiotic Association (GPA) include chicory fiber and other dietary fibers like inulin, resistant starches, certain oligosaccharides and polyphenols.

 Polyphenols, a category of plant-based molecules, may be the next big thing in the nutraceutical industry, thanks to their capacity to support gut health and potential to meet evolving consumer preferences.

Read on as we embark on a journey into the vast potential of polyphenols as prebiotic rocket fuel, and the latest scientific research set to blast the topic into a whole new frontier of opportunity.

Before anything else, let’s go over some essential definitions. For 30 years, scientists, nutritionists and governing bodies have tried to establish a single description of the features that constitute a prebiotic, with little success. Until late 2024, the closest to a unified definition was “a substrate that is selectively utilized by host microorganisms conferring a health benefit.”

 As our understanding of prebiotics and their effects on the body has developed however, so too has the official definition. In recognition of locations of action outside the intestine, the GPA recently recommended that the previous standard of selectivity should be removed, and put forward a new definition for prebiotics: “a compound or ingredient that is utilized by the microbiota producing a health or performance benefit.”

 Happily, the definition of polyphenols – “a diverse class of secondary plant metabolites possessing unique chemical structures and varying functions”

 – has been less controversial, but even more obscure to the general public.

Straightforward explanations like this provide essential context, but in isolation they’re not the most effective route to consumer engagement. Interest in both prebiotics and polyphenols has expanded over the last decade, but according to data from the International Food Information Council (IFIC) only a quarter of survey respondents actively try to consume prebiotics, compared with the almost 40% who state they are increasing their consumption of probiotics.

 It’s clear further work is needed to wake consumers up to the benefits of focusing as much on the ‘fuel’ as the rocket itself.

With this in mind, what are the advantages functional food and supplements brands could highlight to raise awareness and demonstrate the value of prebiotics? The most obvious answer is digestive health support, specifically stimulating the growth of beneficial bacterial strains,

 the production of gut-barrier enhancing short-chain fatty acids (SCFAs)

and the reduction of complaints such as gas, bloating and abdominal pain.

 But in today’s disease-conscious climate however, it’s prebiotics’ impact on immune responses that offers particular promise – and it’s here that polyphenols truly step into the spotlight.

We tend to think of immunity primarily in the context of white blood cells, but with its highly sensitive “pathogen recognition patterns,” the colonic epithelium (the lining of the large intestine) arguably plays an even greater role in rallying the body’s defense system. However, disease, stress and the effects of a poor diet can all impact the integrity and thickness of its mucosal lining, leading to the overgrowth of “bad” bacteria (dysbiosis) and “leaky gut” syndrome.

 An unbalanced gut microbiome and compromised epithelial layer can lead to increased inflammation, metabolic disturbances and—most pertinently—a weakened or overactive immune response.

As non-digestible substances, prebiotics pass from the stomach to the large intestine, where they help re-establish the immune-supporting function of the gut’s mucosal barrier, guard against the production of damaging free radicals by reducing oxidative stress, and create optimal conditions for the growth of ‘good’ bacteria at the expense of less beneficial strains.

While several categories of prebiotics have been shown to impart such effects, emerging research points to polyphenols—such as those derived from European black elderberry (

) fruit—as particularly effective in promoting the growth of the essential strains 

 In addition to the beneficial effects of its anthocyanin content on microbial diversity,

the flavonoids present in black elderberry can bind directly to the virus particles, preventing them from attaching to red blood cells to replicate.

Though elderberries have been a feature in traditional cold and flu remedies for hundreds of years, their status as a prebiotic ingredient with legitimate immunostimulant properties

 is a relatively recent development. Now however, with a growing body of scientific evidence behind them, anthocyanin-standardized black elderberry extracts offer nutraceutical brands a unique opportunity to address some of the modern world’s most fundamental health concerns, just as consumers are truly starting to take notice.

In theory, a balanced diet, rich in high-fiber foods, such as lentils, bananas and oats, is enough to keep prebiotic levels stable. But the realities of everyday life often leave even otherwise healthy digestive systems hungry for support.

Much of the issue comes down to a serious diversity problem. As much as three quarters of the world’s food is derived from only 12 plants and five animal species

 and this homogenous dietary palate is generating generally weaker gut microbiomes that are more susceptible to dysbiosis and diseases.

Consumers are of course seeking answers to this bad gut feeling, even if many aren’t fully aware of the science underlying prebiotics’ effects on digestive health, immunity and metabolism.

 Given this lack of knowledge, secondary factors such as convenience, naturalness and environmental credentials become equally powerful purchase drivers.

Indeed, in a survey of major supplement producers, 88% stated customer expectations were ‘very’ or ‘fairly’ important in motivating companies to adopt more sustainable production practices.

 effective is another key factor, with the pervasive attitude being that such products are healthier, safer and better for the environment—but also potentially less powerful than synthetic alternatives.

 Trend data like this paints a clear picture; shoppers feel that something crucial is missing from their diets, and want to turn to natural solutions to fill the gap but are skeptical regarding their effectiveness. With their fruit origins and built-in consumer trust, polyphenols were already set to address conscious consumer preferences, and now exciting clinical data is also emerging to bolster their status as natural powerhouses. 

Science spotlight: Black elderberry extract, good bacteria and a better gut feeling

Until relatively recently, the microbiota-directed effects of European black elderberry extract have remained somewhat of a mystery —one that researchers at Johannes Kepler University, Austria were determined to bring into the light through an investigation into the effects of a three-week supplementation with black elderberry extract on a group of healthy adults.

Participants were asked to keep a diary of digestive symptoms, beginning three weeks prior to supplementation and extending three weeks after, data from which was compared to weekly biospecimen testing and three evenly-spaced blood tests. From weeks four to seven, the participants ingested a daily dose of 600 mg of a standardized black elderberry extract (ElderCraft; manufactured by Iprona and distributed in the U.S. by Artemis International) which was assessed to contain 18% polyphenol content per dose, equivalent to that of 30 g of raw fruit.

The introduction and withdrawal of the intervention at weeks four and seven of the trial produced significant changes in the measures of microbial α- and β-diversity found within participants’ biospecimen samples. Overall, 92 bacterial taxa (identified at the species level) were assessed to be differentially abundant in samples pre-, during- and post-intervention weeks compared with the participants’ median microbial abundance at baseline.

 Since these sudden changes in diversity closely aligned with the ingestion of black elderberry extract, researchers surmised that supplementation with this polyphenol-rich ingredient produced a relevant microbiome-shaping capacity—in short, demonstrating its value as a prebiotic ingredient.

Like the countdown to ignition at a rocket launch, there’s a point in time just before an ingredient catapults into the mainstream that’s especially valuable to nutraceutical producers. Polyphenols like European black elderberry extract are the latest solution to enter in this dynamic phase in market relevance—offering the exciting potential to nourish the gut, naturally. This intersection between powerful yet lesser-known, novel yet unintimidating, is rich in possibilities for supplement producers and health-conscious consumers alike, and one worth seizing before the fuse runs down and this prebiotic rocket fuel truly ignites the sector.

Patel R.M.; Denning PW. Therapeutic use of prebiotics, probiotics, and postbiotics to prevent necrotizing enterocolitis: what is the current evidence? 

(1),11-25. DOI: 10.1016/j.clp.2012.12.002. PMID: 23415261; PMCID: PMC3575601.

Selvaganapathi G.; Jinat Ahmed J.A.; Mathialagen, A.G.; Dinesh, M.; Azra, N.; Harikrishnan, T.; Kohila, J.R.; Fathy, L.; et al. Meta-Analysis Study the Role of Probiotics Treatment in Irritable Bowel Syndrome (1990-2017). 

Lefevre M.; Racedo, S.M.; Ripert, G.; Housez, B.; Cazaubiel, M.; Maudet, C.; Justen, P.; Marteau, P.; Urdaci, M.C. Probiotic strain 

 CU1 stimulates immune system of elderly during common infectious disease period: a randomized, double-blind placebo-controlled study. 

Baião, R.; Capitão, L.P.; Higgins, C.; Browning, M.; Harmer, C.J.; Burnet, P.W.J. Multispecies probiotic administration reduces emotional salience and improves mood in subjects with moderate depression: a randomised, double-blind, placebo-controlled study. 

 (8), 3437-3447. DOI: 10.1017/S003329172100550X

Global Prebiotic Association. Prebiotic Resources. 

https://prebioticassociation.org/prebiotic-resources/

Deehan, E.C.; Antwan, S.A.; Witwer, R.S.; Guerra, P.; John,, T.; Monheit, L. Revisiting the Concepts of Prebiotic and Prebiotic Effect in Light of Scientific and Regulatory Progress—A Consensus Paper From the Global Prebiotic Association. 

, 15 (12), 100329. DOI: 10.1016/j.advnut.2024.100329.

Rodríguez-Daza, M.C.; Pulido-Mateos, E.C.; Lupien-Mielleur, J.; Guyonnet, D.; Desjarddins, Y.; Roy, D. Polyphenol-Mediated Gut Microbiota Modulation: Toward Prebiotics and Further. 

International Food Information Council. 2021 Food & Health Survey. May 19, 2021. https://foodinsight.org/2021-food-health-survey/

Yoo, S.; Jung, S.; Kwak, K.; Kim, J. The Role of Prebiotics in Modulating Gut Microbiota: Implications for Human Health. 

International Journal of Molecular Sciences

Vulevic J.; Tzortzis G.; Juric A.; Gibson G.R. Effect of a prebiotic galactooligosaccharide mixture (B-GOS®) on gastrointestinal symptoms in adults selected from a general population who suffer with bloating, abdominal pain, or flatulence. 

Reider, S.; Watschinger, C.; Längle, J.; Pachmann, U.; Przysiecki, N.; Pfister, A.; Zollner, A.; Tilg, H.; Plattner, S.; Moschen, A.R. Short- and Long-Term Effects of a Prebiotic Intervention with Polyphenols Extracted from European Black Elderberry—Sustained Expansion of 

Swaminathan, K; Dyason, J.C.; Maggioni, A.; Von Itzstein, M.; Downard, K.M. Binding of a natural anthocyanin inhibitor to influenza neuraminidase by mass spectrometry. 

(20), 6563-6572. DOI: 10.1007/s00216-013-7068-x

Roschek, B.; Fink, R.C.; McMichael, M.D.; Li, D.; Alberte, R.S. Elderberry flavonoids bind to and prevent H1N1 infection 

 (10), 1255-61. DOI: 10.1016/j.phytochem.2009.06.003.

Kinoshita, E.; Hayashi, K.; Katayama, H.; Hayashi, T.; Obata, A. Anti-influenza virus effects of elderberry juice and its fractions beyond. 

Heiman, M.L.; Greenway, F.L. A healthy gastrointestinal microbiome is dependent on dietary diversity. 

(5), 317-320. DOI: 10.1016/j.molmet.2016.02.005

Industry Transparency Center. 2023 Consumer Functional Food and Beverage User Report-General. p. 19, 35, 37-9, 41-2, 46, 47.

International Alliance of Dietary/Food Supplement Associations. How the Food Supplement Sector is Embracing Environmental Sustainability. 

https://www.iadsa.org/sustainability-report

Simão, S.A.V.; Rohden, S.F.; Pinto, D.C. Natural claims and sustainability: The role of perceived efficacy and sensorial expectations. 

, 505-517. DOI: 10.1016/j.spc.2022.09.026.

Explore the prebiotic health benefits of polyphenols and the positive impact they may have on digestive and immune health. Polyphenols, such as those found in European black elderberry, may be an ideal solution for manufacturers trying to break into the digestive health space. 

Polyphenols: The next generation of prebiotics is ready for liftoff

The gut health category is growing and getting more sophisticated. Learn the gaps and best practices in microbiome research to inform your research and development.

https://www.nutritionaloutlook.com/no_w/gut-health

Scientific literature about the gut microbiome continues to grow, leading to rapid new product development. Let’s explore some of this scientific literature to take stock of what is known so far, and what remains to be known. Inform your gut microbiome research and new product development with the latest developments in research best practices and microbiome benefits.

Explore gaps in microbome research to inform future studies and expand knowledge

Learn best practices for microbome research to develop more reliable research and new products

Review the science behind microbiome supportive ingredients to ensure products are developed on a sound scientific foundation.


Postdoctoral Researcher
UC Los Angeles

Dr. Tatiana Diacova completed her PhD at UC Davis in Nutritional Biology. Dr. Diacova is now a Postdoctoral Researcher at UC Los Angeles. She has served on the IAFNS Best Practices for Diet-Gut Microbiome Research committee that recently published an umbrella review discussing best practices, considerations and gaps in knowledge for diet-gut microbiome studies. Tatiana has also recently completed two human trials exploring the effects of walnut and olive oil polyphenols on cardiometabolic health and the gut microbiome. She is currently serving as a Co-Investigator on several additional RCTs aiming to determine the effects of watermelon and pecan food components on whole-body antioxidant capacity, metabolic and gut health.




Scientific Director
International Probiotics Association

Jessica A. Younes, PhD has been IPA's Scientific Director since 2018, bringing both commercial and academic scientific expertise from international biotic supplement, pharmaceutical, and nutrition sectors. She specializes in women’s health and holds a PhD in Medical Microbiology and an MSc Nutrition and Nutraceutical Sciences. Spearheading IPA’s efforts to protect the scientific integrity of the biotic family, she additionally drives a proactive scientific agenda and helps to define and solidify the scientific identity and reputation for the Association. Passionate about all things related to microbes, products, and people, but especially the strategic and responsible translation of biotic science. When you speak with her next, ask this question: “which biotic would win at a game of chess”? You might just be surprised at her answer. 

Webinar Date/Time:
Wed, May 28, 2025 1:00 PM EDT

Webcasts: Health Focus

Gut Health, Under the Microscope

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.

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

Missy Lowery

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