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The discretion period would last 180 from the time a final guidance is published.

New draft guidance says FDA will exercise enforcement discretion for overdue NDI notifications

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, an MJH Life Sciences brand, provides insights and industry updates critical to manufacturers of dietary supplements, healthy foods, and nutritious beverages. 

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ADM (Chicago) is increasing starch production at its facility in Marshall, MN, in order to meet growing demand for ingredients for food and beverages. Expansion is scheduled to be completed in the second half of 2023.

“Three years ago, we announced that we would be phasing out production of high-fructose corn syrup at Marshall and expanding starch production to support increasing demand for products like sustainable packaging,” explained Chris Cuddy, president of ADM’s Carbohydrate Solutions business, in a press release. “In the short time since then, demand has continued to expand, both for food and beverage customers as well as for the broad array of plant-based products that make up our fast-growing BioSolutions platform. This significant capacity expansion will help ensure that we can continue to meet our customers’ needs across this portfolio.” The BioSolutions platform spans everything from packaging to personal care.

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Expansion is scheduled to be completed in the second half of 2023.

ADM increases starch production at Minnesota facility

Early estimates just released by the American Herbal Products Association (AHPA; Silver Spring, MD) put the dietary supplement industry’s initial cost of complying with the requirements of new legislation for mandatory product listing (MPL) at nearly $20 million. The “Dietary Supplement Listing Act of 2022” (S. 4090) 

 Senators Dick Durbin (D-IL) and Mike Braun (R-IN) in April would require every dietary supplement sold in the U.S. to be listed in a federal database, which 

 such as product names, ingredient lists, copies of labels, allergen statements, and structure/function claims.

AHPA says its $20 million estimate covers only the cost of preparing product listings (including data entry) and “does not include associated training costs or other year-over-year costs of continuing compliance.”

It notes, “AHPA staff are continuing to gather data from members of industry to refine this projection.”

In a press release, AHPA’s director of regulatory affairs, Robert Marriott, said, “We are conducting this study because the fundamental question of cost has been missing from the mandatory product listing conversation to date. This information is essential for all stakeholders to weigh the supposed benefits of MPL against its costs to the industry.”

Mandatory product listing requirements could cost dietary supplement industry $20 million for initial compliance, AHPA estimates

stating that the agency will, “for a limited time and in limited circumstances,” exercise enforcement discretion while companies submit overdue new dietary ingredient (NDI) notifications. The discretion period would last 180 from the time a final guidance is published. The agency is now 

 on the draft guidance until July 19, 2022.

Section 413(a)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that manufacturers or distributors of a new dietary ingredient that has not been present in the food supply or has not been on the market in a dietary supplement before October 15, 1994, (the date the Dietary Supplement Health and Education Act passed creating the requirement for NDI notification) must first submit an NDI notification to FDA containing data on the ingredient’s “reasonable expectation of safety” at least 75 days before introducing the NDI into interstate commerce.

 that it believes a large number of supplement companies have not submitted required NDI notifications. The new draft guidance states, “In 1994, there were about 4,000 products on the market; according to recent estimates, there are over 50,000—and possibly as many as 80,000 or more—products available to consumers. Although not every dietary supplement requires an NDI notification, we estimate that more than 4,600 notifications should have been submitted and were not. Despite the expanded marketplace, however, we have received only about 1,200 NDI notifications since DSHEA’s enactment.”

FDA says it will now exercise a 180-day enforcement discretion period, once final guidance is published in the 

 to allow companies that should have submitted notifications time to submit them. This enforcement discretion period is meant to “encourage firms to correct past failures to submit an NDI notification,” the guidance says.

Companies submitting late notifications are required to submit the required NDI notification information as well as “a copy of the current label for the dietary supplement,” the guidance states. Also, it adds, “Since your product is already on the market, we suggest that you also include any evidence related to the history of your product’s use since it has been on the market, including any customer complaints, adverse events (whether serious or non-serious) associated with the product.”

FDA’s draft guidance says that, “In general, FDA intends to exercise enforcement discretion if you submit to us the NDI notification required by 21 CFR 190.6…within 180 days following the publication of a notice in the 

 announcing that the final version of this guidance document is available, and if you can show that the dietary supplement that is the subject of your notification was marketed in the United States as of May 20, 2022.

It expands: “This enforcement discretion policy relates solely to the timing of the requirement to fil an NDI notification…In other words, we generally do not intend to take enforcement action based on a failure to comply with the requirement to file an NDI notification in a timely fashion against firms marketing products within the scope of this enforcement discretion policy.” Notably, it says, the discretion period does not extend to ingredients FDA considers to be adulterated or non-supplement ingredients.

In an FDA press release, Cara Welch, PhD, director of the Office of Dietary Supplement Programs in FDA’s Center for Food Safety and Applied Nutrition (CFSAN), stated, “We remain committed to a flexible framework for dietary supplements that ensures the safety of these products for consumers. The resulting notifications the agency receives through this period of enforcement discretion will help increase the amount of safety information we have about NDI-containing dietary supplements in the marketplace.”

FDA also said it is creating a “new submission type through the CFSAN Online Submission Model” where companies can submit these “late notifications.”

The draft guidance adds: “FDA recognizes that not every dietary supplement containing an NDI is subject to the notification requirement in section 413(a)(2) of the FD&C Act. However, we are aware that some manufacturers and distributors have marketed ingredients and products that are subject to this requirement without having submitted the required notification. A number of firms have told us informally that they realize they should have previously submitted notifications and have this information ready to be submitted, but they are afraid of drawing attention to themselves with a late submission. As part of our ongoing efforts to manage safety risks and to promote risk-based regulation and transparency, we are informing manufacturers, distributors, and other interested persons that we intend to implement a limited enforcement discretion period regarding the requirement to file an NDI notification…”

The draft guidance also warns that FDA might not be able to respond within 75 days of receiving an NDI notification. By law, companies that submit the required notifications can proceed to market after 75 days of notifying FDA, regardless of whether the agency has sent a response. The guidance states that “although we expect to confirm receipt of your submission within 75 days after we receive it, we do not anticipate being able to complete our scientific evaluation and provide a response within 75 days after receipt.”

The Council for Responsible Nutrition (CRN; Washington, D.C.) is applauding FDA for giving companies an amnesty period, though notes that FDA is not without fault when it comes to a lack of a lack of NDINs. "Unfortunately, the concerns the agency expressed are partially of its own making by failing to provide a clear direction for when an NDI notification is required and failing to enforce the existing requirements," said Steve Mister, CEO of CRN, in a press release. "FDA has refused to develop an authoritative list of grandfathered ingredients — or to accept as authoritative — the well-documented lists developed by the industry. Eleven years after FDA first proposed a draft guidance to clarify when an ingredient qualifies as ‘new,’ consumers and industry alike are still waiting for the agency to finalize that guidance."

As a solution, CRN reiterated its support for a master file system to "to protect ingredient innovation and incentivize firms to submit NDI notifications with the assurance that their intellectual property would be protected." 

 this solution alongside the Consumer Healthcare Products Association (CHPA; Washington, D.C.) and the United Natural Products Alliance (UNPA; Salt Lake City, UT), but FDA declined to provide the enforcement necessary to make the system work. 

"FDA cannot expect firms to submit their safety dossiers and manufacturing processes for possible objection when it provides neither meaningful consequences for the failure to file nor a clear roadmap for when an NDI notification is necessary," said Mister. "Enforcement discretion would be better enacted after the above issues are resolved.”

Updated on Thursday, May 19 at 5:29 PM EST

NDI notifications: New FDA draft guidance says agency will exercise enforcement discretion for a “limited time” so supplement companies can submit overdue notifications

 compared the serum calcium levels following consumption of calcium carbonate and natural marine collagenic bone powder made from bone meal derived from Atlantic salmon, called CalGo, which is manufactured by Hofseth BioCare (Ålesund, Norway). In the randomized, double-blind, placebo-controlled study, 12 post-menopausal women between the ages of 55 and 75 were divided into two groups. Group A received four tablets containing 500 mg of CalGo the first day, and the blood was sampled the second day. After a seven-day washout period, the subjects in group A were then given four tablets of 250 mg of calcium carbonate, each, and have their blood samples collected the next day. Group B underwent a similar protocol but in reverse, first receiving calcium carbonate, then switching to CalGo after the seven day washout period.

Results showed that significant increases in serum calcium were experienced when subjects took CalGo, compared to baseline values and calcium carbonate consumption. The day after supplementation with calcium carbonate, subjects saw no significant increases in serum calcium, while 24 hours after consumption of CalGo, subjects saw a significant increase in serum calcium levels by 1.28%.

“At Hofseth BioCare, we understand fresh thinking is crucial to progression and we remain steadfast in our mission to forge a new era in nutrition – one that is sustainable, traceable and most importantly, evidenced and effective,” said Crawford Currie, MBBS, head of medical R&D at Hofseth BioCare, in a press release. “These findings strengthen a growing body of evidence that CalGo is a promising ingredient in sustaining bone health, with both preventative and remedial benefits. Further clinical research studies are ongoing and we are excited to discover the full potential of our naturally-inspired nutritional innovations.”

Currie C et al. “A randomized, blinded, calcium-carbonate controlled cross over study of serum calcium levels 24 hours after CalGo oral supplementation in post-menopausal women.” 

Biomedical Journal of Scientific & Technical Research

, vol. 41, no. 2 (January 26, 2022): 32581-32585, 

http://dx.doi.org/10.26717/BJSTR.2022.41.006583

A recent study compared the serum calcium levels following consumption of calcium carbonate and natural marine collagenic bone powder made from bone meal derived from Atlantic salmon, called CalGo, which is manufactured by Hofseth BioCare

Natural marine collagenic bone powder may increase serum calcium better than calcium carbonate, says recent study

Deep Dive into Postbiotics: Definition and Benefits

Bioiberica (Barcelona) debuted two new branded ingredients during May’s Vitafoods Europe trade show. The two ingredients, DAOgest and Dermial, target digestive health and skin health, respectively.

DAOgest is based on the enzyme diamine oxidase (DAO), which improves histamine digestion. Histamine is present in foods such as alcoholic and fermented beverages, dried fruits, avocados, processed meats, and shellfish. “Histamine intolerance affects an estimated 1%-3% of the global population, causing them to experience allergy-like symptoms after consuming histamine-rich foods,” explained Jaume Reguant, Bioiberica’s healthcare director, in a press release.

Bioiberica says that so far there are limited nutritional tools available to mitigate histamine intolerance. DAOgest is a natural extract the company says is effective at a low dosage of 4.2 mg per serving.

The other new ingredient, Dermial for skincare, is described as “the first hyaluronic acid matrix ingredient of its kind” that helps moisturize skin and maintain skin health. Dermial contains a combination of three naturally occurring ingredients: hyaluronic acid (60%-75% content), glycosaminoglycans (contains at least 10%, and includes dermatan and chondroitin sulfate), and hydrolyzed collagen (contains at least 5%). “Together, they work in synergy to enable the development of cutting-edge products that nourish, hydrate, and replenish the skin,” the firm says.

Bioiberica recently announced the results of a new preclinical study on Dermial showing that oral supplementation of the ingredient “increased type I collagen production by almost half—an observation not seen with standard hyaluronic acid from fermentation or extraction origin.” This study was presented at the Experimental Biology Congress in April.

 study compared supplementation with Dermial to supplementation with standard hyaluronic acid (HA) from fermentation (HA-F) and extraction (HA-E). It evaluated effects on type I collagen production, human dermal fibroblasts (HDF) cell proliferation, and human epidermal keratinocytes (HEK) cell migration. It found that compared to the other ingredients, Dermial 1) significantly stimulated the synthesis of type I collagen by 48% (an effect not observed with HA-F and HA-E), 2) supported cell proliferation of HDF cells at 24 hours at a rate (1.18%) significantly higher than HA-F and HA-E, and 3) increased the migration of HEK cells by 103% (unlike HA-F and HA-E).

The company concluded, “These data reveal that Dermial has a superior effect on inducing the synthesis of type I collagen, cell proliferation of HDF, and cell migration of HEK, compared to standard HA from either fermentation or extraction origin. This indicates that Dermial brings powerful regenerative activity to the dermis and epidermis layers of the skin and supports the maintenance and functionality of the dermis better than standard HA.”

Daniel Martinez Puig, Bioiberica’s head of R&D, human health, added in a press release, “Previous studies have revealed the ingredient’s mechanism of action, ability to be absorbed in the body, and safety when taken orally. But now, we can also confirm that Dermial offers greater efficacy compared to standard HA—a highly sought ingredient in the nutricosmetic market by both formulators and consumers alike.”

Dermial is said to be effect at a low 60 mg/day dose, have good organoleptic features, and has Novel Food and GRAS status. It is a nutricosmetic ingredient suited for dietary supplements and functional foods.

DAOgest is designed to help consumers sensitive to histamine in foods, while Dermial is described as a “first of its kind” hyaluronic acid “matrix” ingredient with a new study showing it outperforms standard hyaluronic acid.

Bioiberica launches new skin health, digestive health ingredients at Vitafoods 2022

The Council for Responsible Nutrition (CRN; Washington, D.C.) is pushing back against mischaracterization of dietary supplements as dangerous and adulterated. A recent study published in the 

 assessed the US. Food and Drug Administration’s (FDA) Tainted Supplements Databased between the years of 2007 and 2021. Its assessment found that 1068 products were found to be adulterated with active pharmaceutical ingredients (APIs), with sexual enhancement and weight loss supplements being the most common culprits. Phosphodiesterase-5 inhibitors were the most common APIs found in sexual enhancement products, and sibutramine, a drug removed from the market due to cardiovascular adverse events, was the most common adulterant API in weight loss products. However, the study did find that muscle-building dietary supplements while commonly adulterated prior to 2016 did not have additional adulterated product identified since 2017.

CRN has taken issue with the study and the media attention surrounding it for being misleading. “Unfortunately, media coverage about this study, and even the study author’s interpretation of the findings, does not tell the complete story. The report shows the number of adulterated products marketed as dietary supplements identified in the Food and Drug Administration’s (FDA’s) database in the 2017–2021 period decreased compared to previous years,” explained Andrea Wong, PhD, CRN’s senior vice president, Scientific & Regulatory Affairs, in a press release. “Further, the percentage of adulterated products in the weight loss category decreased significantly in the same time period, and no adulterated muscle building products were identified. These findings suggest that enforcement and responsible industry action has helped to reduce adulteration in recent years and should be celebrated. Instead, reporting the results as evidence of ‘continued risk’ is unreasonable and unfairly maligns the vast majority of dietary supplements shown to be safe and beneficial in supporting consumers’ health.”

This is why CRN supports the establishment of a mandatory product listing to better monitor adulterated dietary supplement product, says Wong. Unfortunately, adulterated products are a reality in the dietary supplement industry, and consumers have to make educated decisions about the product they are buying. Recently, FDA published a consumer update titled, 

“Caution: Bodybuilding Products Can Be Risky.”

 In the consumer update, FDA warns that bodybuilding products may contain illegal steroids and steroid-like substances that may pose serious health risks such as potentially life-threatening liver injury. FDA advised consumers to stop taking products that claim to contain steroids or steroid-like products, and provided a list of symptoms associated with these products, in case their presence in undisclosed.

In response to this the consumer update, Wong stated that CRN agrees with FDA’s recommendations, but adds that the majority of sports nutrition products are safe and beneficial. “Legitimate sports nutrition supplements—the ones most consumers would encounter in conventional stores or mainstream shopping platforms—are safe, beneficial, and help consumers meet their fitness goals. As with other dietary supplements, these products are meant to complement other smart lifestyle choices, not to replace the hard work and healthy habits that athletes must develop to be well-conditioned,” Wong explains. “CRN continues to call for greater enforcement against products containing substances such as illegal steroids. We supported the Designer Anabolic Steroid Control Act of 2014, which gave the Drug Enforcement Administration additional authority to identify and quickly respond when new designer anabolic steroids are falsely marketed as dietary supplements.

“CRN reminds consumers to seek products from nationally-recognized brands or store brands from trusted retailers, avoid products that promise extreme results, research companies and supporting science, and always talk to a healthcare practitioner for advice on responsible supplement use. Visit our website for more consumer tips on selecting supplements.”

The Council for Responsible Nutrition is pushing back against mischaracterization of dietary supplements as dangerous and adulterated. 

Journal review mischaracterizes dietary supplements, says CRN

Indena (Milan) is promoting two new ingredients it developed using its Phytosome enhanced-bioavailability technology. One is a cranberry ingredient called Anthocran Phytosome, and the other is a berberine ingredient called Berbevis. The company showcased the new ingredients at May’s Vitafoods Europe trade show.

Phytosome is a delivery matrix that uses food-grade lecithin excipients to enhance bioavailability. As the company 

“Phytosomes are molecular formulations in which phospholipids act as vectors for natural active ingredients that are insoluble and tend to self-aggregate, such as polyphenols, terpenes, or saponins. By recreating kinetic aspects lost during purification, Phytosomes determine a significant increase in ingredients’ bioavailability.”

The new cranberry ingredient is called Anthocran Phytosome, which is standardized to proanthocyanidins and contains a full-polyphenolic profile of natural cranberry, including its flavanols, anthocyanins, and phenolic acids. The company says a recent pilot study

 supported the safety and benefits of Anthocran Phytosome for urinary tract health.

The berberine ingredient, Berbevis, “is a new and innovative Phytosome composition applied to 

 to face the issue of berberine’s poor bioavailability and optimize the extract’s health benefits.” The company says, “Clinical evidence shows that Berbevis is a potent, natural health-food ingredient that might help blood sugar control in a plethora of multifactorial challenges, which represent one of our time’s main global health targets.”

Anthocran Phytosome: Prevention of recurring urinary infections and symptoms after catheterization

Published online ahead of print October 10, 2021.

The company showcased the new ingredients at May’s Vitafoods Europe trade show.

Indena introduces extra-bioavailable versions of cranberry and berberine ingredients

Johanna Bolinder is the head of health and sustainability at 

 and is also a registered associate nutritionist with the Association for Nutrition.

A decade ago, people who wanted to improve their diet would need to pay for the guidance of a professional nutritionist or a dedicated dietician. But recent technology advancements have opened up the world of personalized nutrition—and personalized nutrition has now gone mainstream. The specialist nutrition technology that is now available allows individuals to alter their diets and make healthier choices much more easily and cheaply than ever before. These benefits have never been more relevant: For instance, seven out of 10 UK adults want to make healthier lifestyle choices, particularly since the COVID-19 pandemic began, according to a survey commissioned by 

Supermarkets can use specialized nutrition technology to make sure shoppers get personalized recommendations and special offers that match their health goals. The technology can identify and inspire healthier options for consumers and help them track their progress in real time.

One technology in particular works in a similar way to Spotify—but instead of learning which songs people like, the platform learns which foods people prefer. The more consumers use it, the faster the platform can learn from the interactions and offer more personalized experiences based on shoppers’ specific needs.

 has shown that 74% of shoppers would welcome it if supermarkets made it easier to identify healthier options by showing suitable alternatives that are lower-calorie, higher in fiber, and lower in sugar. Digital tools, such as those this new technology offers, mean supermarkets can now do more than simply give healthy meal suggestions or promote healthy recipes. By using personalized nutrition platforms, supermarkets can now help their customers meet their individual health targets.

There is no such thing as a universally healthy diet, as people have unique requirements. Mainstreaming these technological advancements democratizes nutrition and gives shoppers support to match their individual nutritional needs.

AI not only simplifies consumers’ food searches but also makes search results more relevant and enables consumers to understand how to make healthier choices, driving lasting behavior change. One of the benefits of data-led nutrition is that it is scalable at speed, but it still needs a “human in the loop” to make it work.

In this case, that comes in the form of a nutritionist, who makes sure the AI adheres to the highest levels of accuracy and compliance with medical and dietetic guidelines, as well as local legislation. In this way, the AI model can be trained to make sure it complies with the latest advice.

Retailers who use this technology to offer personalization and gamification to their customers benefit, too. The platform not only offers a better experience for shoppers; it also leads to better conversion to sale, larger basket sizes, and increased brand loyalty.

The new developments in technology do not spell the end for conventional consultations with dieticians and nutritionists. A 

 from the University of Newcastle in Australia showed that digital tools, such as personalized nutrition platforms, complement rather than compete with traditional methods of information gathering. A higher level of personalized support combined with dietician advice and monitoring results in greater dietary change, the research found.

Personalized nutrition platforms offer the chance to reach many more consumers and help them make healthy choices. They will not replace nutritionists, but they do offer a way to democratize nutrition and make sure a healthy lifestyle is available for everyone, not just those who are able to afford it.

Seven in 10 Adults Are Motivated to Get Healthier in 2021 Due to COVID0-19.

” Public Health England. Posted January 4, 2021.

American Shoppers Want Help from Supermarkets to Bolster Health and Wellness, Latest Study Finds

Impact on dietary intake of two levels of technology-assisted personalized nutrition: A randomized trial

Supermarkets can use specialized nutrition technology to make sure shoppers get personalized recommendations and special offers that match their health goals.

Personalized nutrition technologies help food shoppers make healthier choices in grocery stores

FoodTech startup Imaginedary Ltd. (Tel Aviv, Israel), which is a developer of animal-free milk proteins, has raised an additional $15 million in its extended seed-round on top of the $13 million it had originally brought in November of 2021. With a total investment capital of $28 million makes this one of the highest-earning seed rounds in the alternative protein space, according to Imaginedairy.

The funding was led by Target Global and joined by the company’s existing investors Strauss Group, Emerald Technology Ventures, Green Circle Foodtech Ventures, Collaborative Fund, New Climate Ventures, and FoodSparks by PeakBridge. Imaginedairy creates animal-free proteins from microorganisms using proprietary precision fermentation technology, allowing the company to produce a wide spectrum of dairy analogs, from raw milk to cheese, without the use of animals. These dairy proteins are non-GMO, cholesterol-free and possess the same flavor, texture, functionality, and nutritional value of its animal dairy counterparts.

The company’s proprietary platform significantly amplifies protein expression, allowing for very cost-effective production of animal-free milk proteins. Cost is one of the biggest hurdles in alt-dairy protein production.

“This extremely successful seed round reflects a strong vote of confidence in Imagindairy and its vision to lead the animal-free dairy industry,” enthused Eyal Afergan, co-founder and CEO of Imagindairy, in a press release. “This substantial injection of capital will serve to advance our ability to make true dairy alternative products a day-to-day reality.”

The funds raised in this seed round will be used to accelerate research and development efforts to launch a range of animal-free dairy products, as well as to help attract additional talent to its expanding workforce.

“We are excited to be able to back the Imagindairy team who have made incredible inroads in creating dairy products that don't rely on industrialized animal agriculture but offer the same level of functionality and nutrition,” said Shmuel Chafets, executive chairman and founder at Target Global. “It is becoming increasingly clear that, given the climate crisis and growing shortage of food, our dietary patterns and habits must change. Animal-free dairy has the potential to become one of the most environmentally impactful industries on the planet. We are strong believers that the Imagindairy team’s vast experience in manufacturing at scale, paired with the cutting-edge technology they have built, will be transformational for this space." Target Global’s contribution to this round marks one of its first investments in the foodTech industry.

FoodTech startup Imaginedary Ltd., which is a developer of animal-free milk proteins, has raised an additional $15 million in its extended seed-round on top of the $13 million it had originally brought in November of 2021.

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How are scientists measuring and supporting longevity?

New draft guidance says FDA will exercise enforcement discretion for overdue NDI notifications