 Global cereal bar launches nearly doubled over the past five years, according to Innova Market Insights tracking. Continued double-digit growth reflects not only the rising demand for these convenient, nutritious snacks and meal replacements, but also the variety of formats, ingredients, and target markets available to companies today.

The European market takes credit for the highest number of launches overall (about one-third of the total launches in 2014), but this mainly has to do with the large number of countries in the region. In actuality, the United States dominates the market and accounted for a significant 26% of total global introductions in 2014. U.S. marketers tend to lead product development in what is otherwise a relatively mature and complex market.

What does the nutrition bar market look like today? It encompasses a wide range of products, including granola or muesli bars and breakfast bars, as well as nutrition bars and energy and performance bars. What’s more, combining different bar attributes and blurring these categorical distinctions is another way marketers are differentiating themselves.

While convenient snacking is the key feature driving the cereal bars market overall, healthfulness is also a major factor. Health appeal is not only important for nutrition and performance bars, including sports and energy products, but also for bars that are marketed as a healthier snack alternative to products such as confectionery, biscuits, and cakes. More than 80% of global cereal bar launches were positioned on a health platform of some kind in 2014, rising to over 90% in the United States alone. Health claims ranged from the passive (natural, organic, low calorie, etc.) to the active (vitamin fortified, digestive health, weight management, etc.).

The nutrition and performance bar category was at one time confined primarily to specialized products for athletes and other active consumers. But dynamic growth in the market over the past decade or so is largely attributed to a move mainstream, primarily in the United States. In short, bars are now much more widely available and consumed on a more casual basis by a broad range of consumers looking for healthier and more portable snacks to support active lifestyles.

At the same time, sub-categories in the market are increasingly blurring as health and performance ingredients are added to more mainstream cereal and granola bars to promote a healthier image while specialized products move to a more general health positioning designed to appeal to a wider audience.

One of the key growth areas in recent years is the heavier use of protein content in mainstream bars. Seventy-five percent of global sports bar introductions used protein claims in 2014, while more than 20% of cereal and energy bar launches also featured this type of claim. In the United States, use of protein claims rose to nearly 79% for sports bars and over 40% for cereal and energy bars.

Protein bars have transitioned from being a specialized product for endurance and performance athletes to a product for the mainstream market, in which shoppers are looking to protein’s potential for benefits such as satiety, weight management, improved muscle mass, and increased energy. Additions to the U.S. market in 2014 included Clif Kid Zbar Protein, Strong & Kind from KIND Healthy Snacks, and Lean Protein & Fiber Bars from thinkThin. Further interesting launches in 2015 include a Yogurt Creme Protein Bar launched under the Powerful Yogurt brand. Powerful Yogurt first launched in 2013 as the first Greek-style, high-protein yogurt for men, featuring a larger, “man-friendly” 8-oz cup and 25 g of natural protein per container.

Other health claims featuring strongly in the cereal bars market include “gluten free,” used on just under 30% of global cereal bar launches and more than 50% of launches in the United States. Following that, “high in fiber”/“added fiber” claims showed up on 25% of global launches-and more than 32% of launches if “whole grain” claims are included, as well.

As well as this focus on health claims, there is also ongoing demand for indulgence and novelty, with consumers looking for new textures and flavors as well as the use of delectable ingredients such as fruits, nuts, and chocolate. Nearly half of cereal bar launches featured fruit (led by berries/summer fruits), and more than 38% featured chocolate and 27% featured nuts.

This trend is showing up in both specialized and mainstream products, with rising interest across the board in more exotic, complex, and dessert-style flavors. The Clif Builders Protein bar line, for example, added a Chocolate Hazelnut version, while Thinkthin launched a Chocolate Coconut Almond Protein flavor, Perfect Bar added an Almond AÃ§ai option, and Kellogg pegged on a Salted Caramel Chocolate line to its Special K snack bars range.

The nutrition bar market, along with the cereal bar market as a whole, seems set for further growth, even in the face of a relatively mature market in the United States. Ongoing interest in convenient, nutritious, indulgent snacks suitable for consumption on the go is set to drive the market forward, while existing and new need states and consumption occasions also present opportunities. But a word of caution: with ongoing high levels of product activity, including new types of products and blurring categories, differentiating products in an increasingly crowded and complex marketplace is likely to become more of a challenge.

Articles

Nutrition bar companies are leveraging new formats, ingredients-and target markets.

Today's Hottest Nutrition Bar Trends

Photo © iStockphoto.comPhoto © iStockphoto.com/

 Photo © iStockphoto.com/With demand for gluten-free foods high and growing strong, the hunt is on for new non-wheat flours.

Alternative flours made from nuts, rice, coconuts, and tapioca are experiencing the strongest growth in a U.S. gluten-free flour market that grew by 10.8% in the last year, reaching $126 million as of May, according to SPINS (Schaumburg, IL). But banana flour, a newcomer to the U.S. market, may have what it takes to rise, brown, and bake with the best of them.

“Bananas pretty much speak for themselves in the world of nutrition,” says David Wintzer, co-creator, WEDO (Park City, UT). WEDO first began selling green banana flour last year after a successful Kickstarter launch in February 2014 and is the first U.S.-based supplier of banana flour, says Wintzer.

Widespread knowledge of banana’s nutrition may be what hooks consumer interest, but pleasant taste, formulation ease, and environmental sustainability are a few reasons why this new gluten-free flour could be here to stay.

There has to be one question that comes first with an alternative flour: how does it compare to wheat in formulations?

“Green banana flour, in high-standard form, bakes incredibly well and is a very rare gluten-free flour that can rise and remain, as it is starch-based,” says Krista Watkins operations manager at Natural Evolution Foods (Australia). Natural Evolution Foods has been selling banana flour for the past five years within Australia, and in May the company began selling to North America over the Internet.

Watkins says banana flour does differ from wheat flour with its “wholesome earthy flavor” and slightly darker coloring when cooked, and, as with many gluten-free flours, a binding agent may be necessary in certain formulations.

“When making dough recipes such as pasta, pizza bases, or pastries, we recommend using xanthan gum [as a binder],” says Watkins. “However, we have made many different loaves of bread without xanthan gum and have found chia seeds and eggs work well as binding agents also.”

It also takes less banana flour to achieve a similar effect as wheat in formulations. Sometimes just two-thirds as much flour will do the trick, according to WEDO’s Wintzer.

“If you go cup for cup with our flour, you will end up with a hockey puck,” says Wintzer.

As for potential health benefits, many consumers know that bananas are a good source of potassium, fiber, and other essential vitamins and minerals. But green banana flour from both WEDO and Natural Evolution Foods also boasts a high content of resistant starch, which has been shown in several studies to have prebiotic properties. The only drawback is that resistant starch may lose its nutritional value if the flour is baked, so the starch appeal could only apply to smoothies or other raw products, says Wintzer.

Natural Evolution Foods began selling banana flour to North America in May. Photo from Natural Evolution Foods.

Unripe green bananas are ideal for flour because of their high starch content, but they are also “green” in terms of being sustainable. Both WEDO and Natural Evolution Foods use bananas that farmers would normally discard because they are abnormal in size or shape, but are otherwise perfectly fine.

Banana flour is currently slightly more expensive than many other gluten-free flours on the market, but that could change as companies find more efficient ways to produce the flour without sacrificing nutritional value. WEDO currently blanches its bananas to make peeling easier, while Natural Evolution uses a cold-fused process that it says preserves the fruit’s nutrition better than boiling. But WEDO’s Wintzer says boiling isn’t the issue; it’s drying the bananas without cooking away the resistant starch that’s the real challenge.

Banana flour may be new to the market, but its strong profile shows that this gluten-free flour isn’t monkeying around.  

Are Dietary Supplements Going Gluten-Free?

Banana flour arrives on the gluten-free scene.

Banana Flour Is the Latest Gluten-Free Flour Option

The subject of DNA testing herbal products remains controversial after New York Attorney General Eric Schneiderman (NY AG) used the method to investigate dietary supplements earlier this year-an investigation that ultimately saw products pulled from store shelves.

 from leading industry groups that DNA testing is not an appropriate method for authenticating finished herbal products, nevertheless companies caught up in the NY AG’s investigation eventually, in order to get their products back on shelves, reached agreement with the NY AG to 

 operations. Months later, after mainstream attention and weigh in from the scientific community, how has DNA testing trickled down into the heart of the industry?

According to one ingredient supplier, more supplement companies are now actively requesting DNA testing. As a result, cranberry supplier Fruit d’Or (Notre-Dame-de-Lourdes, QC, Canada) says it is adding DNA testing to its test offerings for clients, says Stephen Lukawski, director of global business development, sales, and marketing.

DNA testing requests ramped up soon after the NY AG investigation, Lukawski confirms. “Really, the DNA barcoding was brought to us unexpectedly, and we had to be proactive and really take a position. Do we swim against the current, or do we go with the current?”

Fruit d’Or’s reaction is not simply kneejerk, though. The company does believe that DNA testing has value as 

 of a broader testing palette. “That’s why we brought in the DNA testing,” Lukawski says. “We felt that it has a purpose, but we still have to educate and explain our story of why we’re introducing [it]"-including, he says, the fact that the company is using DNA testing properly, on appropriate product forms, and in combination with many other-and, in some cases, trailblazing-methods for cranberry proanthocyanidin (PAC) identification and quantification.

It should further be noted that Fruit d’Or had been very active in pushing for the advancement of cranberry testing standards well before the issue of DNA testing came up. The firm believes that by advancing the characterization and quantification of cranberry PAC content, including insoluble PACs, the cranberry industry could one day unmask a world full of cranberry health benefits beyond urinary tract health alone.

, Fruit d’Or announced it had begun working with phytochemistry consultant Complete Phytochemical Solutions LLC (Cambridge, WI) to quantify the insoluble PACs in Fruit d’Or’s CranNaturelle cranberry ingredients. Until then, it had been most common to 

-for instance, in cranberry juice. Today, the companies are using not only the longstanding BL-DMAC method to quantify soluble PACs, but also a butanol-based method to 

 as well as MALDI-TOF mass spectrometry to authenticate PACs. (

Click here for more on the MALDI-TOF method for cranberries

.) Furthermore, the companies are touting a new reference standard, C-PAC, that they believe is “the most accurate way of being able to quantify PACs for cranberries,” especially fruits and fruit powders, instead of just the PAC A2 dimer reference standard used by the juice industry.

Within this “portfolio of analytics,” says Christian Krueger, Complete Phytochemical Solutions CEO, DNA testing is only 

of a more comprehensive program to push cranberry testing forward, and some methods fill holes that others don't. For instance, "While DNA barcoding is applicable for authentication of the cranberry fruit (raw material), it does not provide qualitative (what does it look like) or quantitative (how much is there) information on the bioactive constituents (PACs) of cranberry raw ingredients and/or final formulated products," Fruit d'Or stated in a July press release. And that's when a method like MALDI-TOF mass spectrometry can step in for authentication and the BL-DMAC and butanol methods can work for PAC quantification.

“We think of MALDI-TOF as being complementary to DNA testing. That’s to say that where DNA is present, DNA testing is valuable and appropriate. But when you [can no longer detect the DNA in a finished product], you need to be able to fall back on another test method that would help still authenticate the product," Krueger says. "So there’s a real synergy there."

He adds, “We always want to keep an open mind as to how many tools we can use and what they’re actually going to be able to tell us at the end.”

It’s a sentiment Lukawski echoed in a July press release announcing Fruit d'Or's new DNA testing: “We need stakeholders who are able to accept and adopt new test methods and introduce new analytical equipment in order to prevent adulteration, establish authenticity, and create standardization.”

And there's a practical reason to consider DNA testing, too, he says. In the end, offering DNA testing not only ensures that Fruit d’Or can meet client requests, it also leaves the door open to working with any of the big-name companies who already committed themselves to DNA testing via the NY AG agreement. “If we want to do business, we have to raise our own standards,” Lukawski says. And that, some would argue, is one more reason to keep an open mind to DNA testing.


Editor-in-Chief
Nutritional Outlook magazine


DNA Experts Discuss What Makes Testing Difficult in NY AG Case

Why Won’t NY Attorney General Schneiderman Release the Report? (Editorial)

Editor: New York Attorney General Case Requires Strong Response, Supplement Leaders Say

Post NY AG investigation, how has DNA testing actually impacted the dietary supplements industry?

Why We’re Adding DNA Testing, Ingredient Supplier Explains

Protein remains one of the hottest trends in functional foods and beverages, with an ever-widening range of animal and plant-based proteins on display at this year’s 

Institute of Food Technologists’ Annual Meeting & Food Expo

 (IFT 15). Protein heavyweights whey and soy shared the show floor with relative newcomers like faba bean, pumpkin seed, and other plant-based alternatives.

But that booming market comes with competing views on the best method for evaluating protein quality. For more than twenty years, the Protein Digestibility Corrected Amino Acid Score (PDCAAS) has been the accepted standard for measuring protein quality, but some experts are pushing for a new method they claim is more accurate.

That new method-the Digestible Indispensable Amino Acid Score (DIAAS)-was recommended by the Food and Agricultural Organization of the United Nations (FAO) in a 

. Although PDCAAS is still widely accepted in the industry, some, especially in the dairy protein sector, are pushing for a switch to DIASS.

“With this new method, it will help to differentiate precisely the superiority of dairy protein versus other plant sources,” says Moises Torres-Gonzalez, PhD, director of nutrition research, National Dairy Council (Rosemont, IL). Torres-Gonzalez says DIAAS is superior because it measures only the amino acids that are absorbed in the small intestine, while PDCAAS includes amino acids in the entire intestinal tract, which may not come from dietary protein.

Another big difference is that PDCAAS offers a maximum score of 1, while there is no maximum with DIAAS. This would slightly raise the score of many proteins, but dairy proteins see the greatest score increase under DIAAS, according to the U.S. Dairy Export Council.

“For instance, right now with the PDCAAS, soy protein is equal to whey, but that’s because it is just truncated at 1,” says Torres-Gonzalez. “But some preliminary results using the DIAAS have shown that whey and dairy proteins are much higher in quality compared to other sources.”

However, not everyone is as ready to abandon PDCAAS, especially because formulators are accustomed to maximizing PDCAAS scores in their products. BI Nutraceuticals (Long Beach, CA), a supplier of both plant and animal proteins, is sticking with PDCAAS right now because that’s what customers are asking for.

“For us, whatever our customer asks for, we’ll test that and give that number,” says Alison Raban, certified food scientist. Raban and George Pontiakos, BI president and CEO, were both skeptical of DIAAS as such a novel, and possibly immature, testing method.

“Everybody will find a test that works for their ingredient,” says Raban. “The rice people will say one thing; the soy people will say another thing.”

For Hinoman (Tel Aviv, Israel), which debuted its newly GRAS-affirmed mankhai protein at IFT, the small company had to make a decision between getting a PDCAAS or DIAAS score for mankhai.

“Unfortunately, we were really on the verge of doing [DIAAS], but most of our customers asked for the PDCAAS, so we’ve done the PDCAAS,” says Udi Alroy, vice president of marketing and business development, Hinoman. However, Alroy says that Hinoman is still looking to include DIAAS for mankhai in the future.

“I think the DIAAS will be much better than the PDCAAS,” says Alroy.

There’s at least one thing you don’t need a test to tell you about protein: it’s still one of the most powerful forces on the market today.

Plant Protein versus Dairy Protein for Muscle Building

How Big a Threat Is Plant Protein to Dairy Protein?

Michael Crane
Associate Editor
Nutritional Outlook Magazine


PDCAAS has set the standard of protein quality for more than 20 years, but some experts want to replace it with the new DIAAS method.

Does PDCAAS Still Set the Bar for Protein?

There’s no shortage of suggestions when predicting the next breakout bottled-water celebrity after coconut water. Will it be maple water? Cactus water? 

Read our own recent overview of the latest drink innovations to hit the market.

 Flavor specialist Virginia Dare (Brooklyn, NY) has its own proposal: banana water.

“Bananas have certainly been around for a long time and have been incorporated into smoothies, nectars, cocktails, and many other kinds of drinks. When coconut water began its meteoric rise in popularity some time ago, the marketing insights team at Virginia Dare carefully studied its product profile,” says Anton Angelich, group vice president, marketing.

In short, he says, what the team determined is that banana water shares some of the very same health perks that made coconut water a star in markets like the United States. Coconut water is celebrated for its rich supply of rehydrating electrolytes-namely, potassium-which, as you may have heard, bananas contain a lot of.

Citing banana as a “widely appealing and popular taste,” Virginia Dare has at least two product concept suggestions. The first drink is clear and aimed at thirst quenching, with clarified banana juice concentrate and such flavors as banana cream, pineapple banana, raspberry banana, strawberry banana, and chocolate banana.

The second is a cloudier, juicy beverage made with banana puree and pear juice. Flavors might include banana cream, pineapple banana, raspberry banana, or strawberry banana, the firm says.

Perhaps the biggest boon is the strong connection consumers already draw between bananas and potassium content. “The association between bananas and potassium is well known,” Angelich says, particularly among baby boomers and mature consumers who may have failed to connect with coconut water, perhaps because initial marketing for coconut water skewed towards “celebrity endorsed [marketing], targeted at younger fitness-interested consumers,” and being premium priced, to boot.

These very consumers, he says, may more readily accept banana water. “Add on to this the fact that coconut can be a polarizing flavor, bananas are very popular in taste, and banana concentrates and juices are in good year-round supply,” and bananas bring a lot to the table, he adds.

For a market that’s recently “seen artichoke, cucumber, watermelon, beet, rhubarb, and mint waters come onto the horizon, banana water stands a good chance of making it with the consumer in the marketplace,” he concludes.

Drink Pioneers: The Next Generation (Slideshow)

Can banana water reach consumers-namely, mature shoppers-that coconut water can’t?

Is Banana the Hot New Water Flavor?

Slideshows

Probiotic breakfast burritos, cricket chips, tea popsicles, and more enter the functional foods arena.

8 New Functional Food Innovations

Nitric oxide (NO) plays a key role in supporting blood flow and oxygen delivery to muscles after intense exercise, and a new study suggests a combination of Setria Glutathione and L-citrulline may be effective at increasing NO levels in young men after resistance exercise sessions.

The double-blind study, led by Darryn Willoughby, PhD, and published in the 

Journal of the International Society of Sports Nutrition

, investigated the effects of Setria Glutathione and L-citrulline on 60 healthy, resistance-trained males aged 18-30. Setria Glutathione is manufactured by Kyowa Hakko USA Inc. (New York City).

The men were randomly divided into four groups and received either a placebo, 1 gram Setria Glutathione, 2 grams L-citrulline, or a combination of 200mg Setria Glutathione and 2 grams L-citrulline to take daily for one week. At the end of the 7-day period, the men performed resistance exercise sessions involving the elbow flexors and their blood was collected to assess NO levels.

The researchers found that the combination of Setria Glutathione and L-citrulline did in fact increase NO levels in the blood to a significantly greater degree than the placebo. What’s more, at 30 minutes after the exercise, the Setria Glutathione/L-citrulline group was the only group to present such a striking improvement over the control group.

“In the present study, significantly different increases in NOx occurred 30 min following resistance exercise, and only for the L-citrulline and [Setria Glutathione] group,” wrote the study’s authors. The combination also increased levels of plasma cGMP, but not significantly.

 and rodent study of the effects of the Setria Glutathione and L-citrulline combination, which also found that the combo “has the same positive, long lasting benefit of enhancing nitric oxide across a variety of subjects, as well as blood levels of NOx,” according to a press release.

“In this study, we were able to determine that combining Setria Glutathione with L-citrulline not only increased blood levels of nitrite and NOx, but sustained the increases for a longer period of time, compared to placebo,” said Willoughby. “The results of this first-of-its kind study indicate that Setria Glutathione and L-citrulline may play a role in muscle protein synthesis and muscle performance when combined with resistance exercise.”

McKinley-Barnard S et al. “Combined L-citrulline and glutathione supplementation increases the concentration of markers indicative of nitric oxide synthesis.” 

L-Citrulline/L-Arginine Combination May Improve Circulation: Animal Study

A new study suggests a combination of Setria glutathione and L-citrulline may be effective at increasing nitric oxide levels after exercise.

L-Citrulline Plus Setria Glutathione May Support Muscles After Exercise

Longer-term methylsulfonylmethane (MSM) supplementation results in higher blood MSM concentrations, confirms a new study published in 

The month-long study is the first longer-term trial to demonstrate the effects of MSM, a common joint- and muscle-health ingredient, on serum levels.

“While MSM has been known to have excellent bioavailability, published data within the public domain regarding serum concentrations following chronic ingestion is minimal,” said Rodney Benjamin, director of research and development, Bergstrom Nutrition, in a press release. The study researchers used Bergstrom’s OptiMSM brand ingredient.

The researchers, including Benjamin, administered 40 healthy men a placebo or 3 g of OptiMSM daily for four weeks. Blood samples were taken at baseline, week 2, and week 4 using nuclear magnetic resonance (NMR) spectroscopy.

Serum MSM levels were higher at both weeks 2 and 4 over baseline, with researchers estimating an approximate 1-3 millimole (mM) increase two to four weeks into supplementation.

People may not get a high enough intake from typical dietary MSM sources, which include milk, fruits, vegetables, coffee, and tea, as processed food production can diminish MSM presence in finished goods. Unlike short-term MSM serum studies, this randomized, double-blind, placebo-controlled study shows that serum levels remain higher after chronic ingestion.

“It was our objective through this study to provide a base data set for potential future dose and time-ranging studies that may assist in optimizing the suggested dosing of MSM, in particular as its popularity continues to grow,” the researchers wrote. “Daily supplementation with MSM at a dosage of 3 g reliably increases serum MSM concentrations,” they concluded.

Most subjects’ serum levels were not different between weeks 2 and 4. Was there a leveling-off effect, or is 3 g considered a maximum dosage? “The maxima hasn't been fully determined,” Benjamin cautions. “In other words, a higher dosage for longer time may be able to achieve higher than 3 mM.” Another of the researchers, Richard Bloomer, calls the study a “starting point” for determining dosage and time ranges for MSM supplementation.

The researchers said more studies are needed to show whether serum MSM levels continue to rise following even longer-term use.

Researchers administered 40 healthy men a placebo or 3 g of OptiMSM daily for four weeks.

MSM Supplement Boosts Blood Levels in a First Longer-Term Study

More than half of Americans may take dietary supplements

, but the majority of those supplement users might not be telling their physicians about their supplement use.

A new study of 558 inpatient records by the Boston Medical Center (Boston) revealed that only 6% of patients were asked by their physicians about dietary supplement use, disclosed that use to a physician, and had their dietary supplement (DS) use documented. In some cases, this lack of communication between physicians and their patients about supplement use can present a health hazard.

“If clinicians are unaware of possible drug-DS reactions, they may unknowingly provide a treatment plan or prescribe medications that could have an adverse reaction or interactions with the dietary supplement,” says Paula Gardiner, MD, lead author of the study and assistant director for the Program for Integrative Medicine and Health Care Disparities. She added that supplement use can also affect medical procedures such as surgery, chemotherapy, blood work, and others.

The study included 558 patients aged 18 and older who came from a “cohort of low-income, racially-diverse prescription medication users,” according to the study. All of the participants were treated at Boston Medical Center, with patient records collected from October 2008 to October 2010.

60% of the participants included in the analysis reported using dietary supplements. Among those supplement users, 36% had documentation of dietary supplement use in the medical chart, 20% were asked about supplement use by a provider, and 18% reported telling a provider about their supplement use. Overall, only 6% of participants were asked, disclosed, and had documentation of dietary supplement use.

“Research has shown that some of the reasons patients do not disclose dietary supplement use is because they either don’t know that physicians need the information, or sometimes there’s a fear of being judged by a clinician,” says Gardiner.

The study also suggested that documentation of medical supplement use “decreases with increasing patient age, and is lower among those who self-identify as Hispanic or a race other than Caucasian.”

In a press release, Gardiner highlighted the need for medical schools to educate tomorrow’s physicians “about the importance of DS dialogue with patients of all ages and cultural backgrounds.”

“Physicians need to establish a formalized approach to DS documentation to help prevent adverse reactions from dietary supplement-prescription medication interactions and ultimately to improve outcomes," says Gardiner.

Gardiner P et al. “Medical reconciliation of dietary supplements: don’t ask, don’t tell.” 

How the Healthcare Professional Evaluates Dietary Supplements

Doctors and Dietary Supplements: Using, Recommending, Selling

A new study by the Boston Medical Center suggests that patients who use dietary supplements may not be telling their physicians about their supplement use.

Communication Failure about Supplement Use between Patients and Physicians?

 in June, attorneys general from New York and Indiana are calling on FDA to swiftly fix a “serious flaw” in the agency’s good manufacturing practices (GMP) regulation for dietary supplements-the “flaw” being the fact that ingredient suppliers are not subject to the GMP rule. The AGs’ letter to FDA comes on the heels of a citizen petition filed in May by a recently forged association, the 

 (ONHA), also asking FDA to require suppliers to answer to GMPs. It also follows a 

letter from a group of 13 attorneys general

, again led by New York AG Eric Schneiderman, asking Congress in April to strengthen FDA oversight of the supplements industry.

FDA’s dietary supplement GMPs (21 CFR 111), enacted in 2007, apply to supplement manufacturers only, not ingredient suppliers. Interestingly, when FDA first proposed the GMPs in 2003, the regime did include suppliers. But when FDA released the final regulation in 2007, it excluded them. (The agency noted that it received comments during rulemaking supporting including suppliers, as well as comments objecting to their inclusion. American Herbal Products Association (AHPA; Silver Spring, MD) President Michael McGuffin says that AHPA supported the initial proposal to include suppliers.)

In an October 2007 public broadcast, FDA made clear that GMPs pertained only to supplement manufacturers:

“The Final Rule does not apply to dietary ingredient manufacturers or suppliers, but only to persons who manufacture, package, or hold dietary supplements. The manufacturer is thus responsible for ensuring that the ingredients used in the production of a dietary supplement are such that they produce a product consistently meeting cGMPs.”

, “It is important to note that excluding raw dietary ingredient producers/suppliers from cGMP does not weaken the rule, but rather shifts the burden for ensuring the quality of dietary ingredients used in dietary supplements to the manufacturer of the final product. A finished-product manufacturer still needs to ensure that the dietary ingredients used are the appropriate ones for the manufacturer's final product. This assurance of quality requires, at a minimum, an identify test of each incoming dietary ingredient to verify that the key ingredients are what they are purported to be.”

 (These statements were made by Vasilios “Bill” Frankos, MS, PhD, then-director of FDA’s Division of Dietary Supplement Programs. Frankos is now senior vice president of global product science, safety, and compliance at Herbalife.)

Dan Fabricant, CEO and executive director of the Natural Products Association (NPA; Washington, DC), says that it was an “economic” decision on the part of FDA to remove suppliers from the rule. (Fabricant served as directorÃ¢ÂÂofÃ¢ÂÂFDA’s DivisionÃ¢ÂÂofÃ¢ÂÂDietaryÃ¢ÂÂSupplementÃ¢ÂÂProgramsÃ¢ÂÂin 2011–2014.) According to Fabricant, including suppliers would have “[driven] up costs in a way that doesn’t necessarily provide a benefit.” Case in point, he says: depending on where ingredient suppliers stand in the finished-product supply chain, requiring them to follow GMPs might not make sense. “For example, if a manufacturer buys a raw agricultural commodity and extracts it further, why should that ingredient supplier have to have a specification and a test for strength? So subjecting [ingredient suppliers] to the exact same rules [as manufacturers] just didn’t fit,” he says.

Many also expected that GMPs would indirectly force suppliers to up their quality-control procedures simply because manufacturers, in their efforts to meet their own GMP burdens, would require their suppliers of ingredients to provide stronger assurances of quality and safety. (

Among those now asking FDA to revisit the rule to include suppliers, ONHA’s CEO and Executive Director Karen Howard tells 

, “Not having the cGMPs apply to ingredient suppliers definitely creates a gap in supply-chain integrity.”

Howard points out that neither ONHA nor the AGs, including New York AG Schneiderman, whom ONHA has been 

 on regulatory-overhaul proposals, have fully fleshed out just how suppliers should brought into the GMP fold. “I don’t think we have any prescriptive recommendations at this time. I think there’s some work that has to be done around what that means, what nuance has to be attributed to a different set of GMPs or a like set, and what that would look like,” she says.

Ray Matulka, PhD, director of toxicology for Burdock Group Consultants (Orlando, FL), told 

that a singular, across-the-board GMP regulation would likely be complicated, considering that suppliers’ ingredient offerings are diverse and require varied specifications and testing. Calling the manufacturing process for finished goods “much more controlled,” Matulka points out that ingredients such as wild-sourced botanicals follow a different supply-chain roadmap than synthesized vitamins. “There’s such a wide range and such a diversity of different supplements that you’re going to be mandating aspects that probably do not fit for a certain segment of supplements, and therefore some manufacturers just will not be able to meet a mandate because it’s not feasible for their production process,” he says. “That’s trying to fit every square into a round hole, and it’s just not going to work.”

While Howard agrees that “there should always be some flexibility at the manufacturing level and the processing level,” it’s uncertain what a supplier GMP might look like. Howard again reiterates that “we haven’t gotten into that level of detail yet.” But she contends that ingredient suppliers do share some similarities in how they meet their responsibilities today. “When you look at what contract manufacturers generally request from their raw-ingredient suppliers, it’s identity, it’s microbial tests, it’s certificate of analysis. Contract manufacturers of varying interests require their ingredient suppliers to provide different kinds of tests. All of the ingredient suppliers know what those tests are.”

At the macro level, she says, mandating supplier GMPs would shift some of the GMP onus off manufacturers. “It could potentially reduce the burden on the contract manufacturer and spread it out across the supply chain. Because right now, all [the suppliers] do is push all of the risk down to the contract manufacturers.”

And, she says, “We’re not going to say that if the raw-ingredient suppliers do four tests, then the contract manufacturer supplier doesn’t have to do any. There’s an obligation to the consumer to keep that integrity of the supply chain moving forward at each step, so there have to be checks and balances along each step of the manufacturing process.”

Identity testing, microbial analysis, traceability. Putting GMPs aside, do any existing FDA regulations already make ingredient suppliers directly answer to these types of quality-control measures? Yes, in theory. FDA’s Food Safety Modernization Act (FSMA), made law in 2011 and still rolling out now, includes two rules that will, once 

, apply directly to ingredient suppliers.

FSMA’s Preventive Controls for Human Food regulation will require ingredient suppliers to identify potential hazards, including adulterants and contaminants, and to establish prevention protocols. Meanwhile, FSMA’s Foreign Supplier Verification Program is expected to safeguard the foreign ingredient supply chain by ensuring that foreign suppliers meet the same GMPs and hazard-analysis rules required of U.S. suppliers.

These FSMA requirements will “hugely” affect supplier quality, says AHPA’s McGuffin. “It’s going to require the suppliers to meet a very high standard for manufacturing practice and prevention control.”

He continues, “The FSMA rule is going to place pretty much the same burden [that manufacturers face under their GMPs] on the supplier because [the supplier is] going to have to establish identifying hazard points and establish prevention controls. So if you’re in the business of supplying those ingredients, you’re going to have the same burden outbound as the manufacturer is inbound. So it will be controlled twice; it will be controlled by the supplier, and it will be controlled by the manufacturer.”

He also points out that FSMA itself is a GMP system. “[FSMA and the dietary supplement GMPs] are both GMPs. Right now, ingredient suppliers have to comply with the GMPs for foods (21 CFR 110). That’s going to get repealed [with FSMA’s implementation], and then they’re going to have to comply with the new GMP for foods [FSMA], which includes the Preventive Controls (21 CFR 117). And supplement companies have to comply with 21 CFR 111, the dietary supplement GMPs. Do I believe that ingredient suppliers’ compliance with 21 CFR 117, in combination with manufacturers’ compliance with 21 CFR 111, constitutes sufficient protection to ensure quality of the finished product? Absolutely.”

Of course, FSMA’s success remains to be seen and depends on how the regulation works once fully operational. Neither the Preventive Controls nor the Foreign Supplier Verification arms of FSMA have fully rolled out.

Howard calls FSMA’s success “pure speculation at this point,” and NPA’s Fabricant says, “They haven’t been implemented yet, so it’s tough to say. I would like to think that they will be, but we need to wait to see what the implementation looks like and what the plans are like rolling out.”

Some, like ONHA and the AGs mentioned earlier, say they do not want to wait years to see whether FMSA will help. “I think, in theory, [FSMA] is something that is potentially viable, but it also could be two, three, four, five, six years out,” Howard says. In the meantime, if there are problems with industry-wide quality control-“and people have acknowledged there has been a problem for a long time,” she says-“then what can you do immediately? What can be expedient and effective? Our position on that is, at a minimum, the raw-ingredient suppliers need to be able to adhere to GMPs.”

“There’s no need to wait for congressional action to drastically improve federal oversight of the dietary supplement industry,” AG Schneiderman said in his press release announcing the June letter sent to FDA claiming that “by exercising the agency’s rulemaking authority, FDA can independently achieve certain vitally needed reforms.”

Does FDA even have the bandwidth for a GMP rework at this point in time? “I don’t think that they would be able to do that at the moment,” Burdock’s Matulka says. “They’re having a hard enough time getting FSMA implemented, and so to take an extra step and overhaul the GMPs for dietary supplements while they’re also trying to adhere to these guidelines for FSMA, I don’t see how they could do that at the moment.”

Fabricant says that in his opinion, it would be better to wait to see how FSMA plays out. “Let’s see what happens with the Preventive Control Rules, and we’ll take it from there. I don’t see [amending the GMPs] as a necessity.”

NY Attorney General Extends Investigation to Manufacturers

“Not having the cGMPs apply to ingredient suppliers definitely creates a gap in supply-chain integrity, says ONHA’s CEO and Executive Director Karen Howard.

 Should FDA’s Dietary Supplement GMPs Include Ingredient Suppliers?

For the first time, the U.S. Department of Agriculture (USDA) Process Verified Program (PVP) has verified a company’s non-genetically modified organisms (GMO)/non-genetically engineered (GE) claim.

On May 18, SunOpta (Brampton, Ontario, Canada) announced that its Hope, Minnesota facility is the first in the United States to receive USDA PVP verification for being non-GE/GMO. The facility will now be able to produce PVP-verified non-GMO soybeans and corn.

, Secretary of Agriculture Tom Vilsack told USDA employees that “other companies are already lining up to take advantage of this service.”

Yet, although this is USDA’s first foray into PVP-verification of non-GMO products, the agency has still not gone so far as to set its own non-GMO standard

“Instead, it has verified that one company’s manufacturing facility has met its own standard when making a claim that its product is non-GMO,” according to a 

 from the American Herbal Products Association (AHPA, Silver Spring, MD).

AHPA also raised concerns that the USDA’s Natural Organic Program (NOP) and the non-GMO verification program by PVP are being coordinated separately, despite both being administered by USDA’s Agricultural Marketing Service (AMS).

“Products that meet the NOP standard should also have their non-GMO labels recognized as verified instead of having to pay an additional fee for a claim that has already been verified by AMS through NOP,” said AHPA President Michael McGuffin, in a press release. “USDA should be commended for their effort to meet consumer demand for information about non-GMO products, but it seems unlikely that the PVP will provide the comprehensive solution needed to address this issue. Ultimately, a more comprehensive solution is needed.”

Steve Bromley, CEO of SunOpta, called USDA’s non-GMO verification a “great honor for SunOpta and consistent with our commitment to non-GMO and organic food products which are in high demand with today’s consumers.”

“Having USDA verify that we are complying with out standards ensures that our customers can be confident that they are getting the highest quality non-GMO soybeans and corn,” said Bromley, in a 

. “We look forward to implementing the USDA PVP program at other SunOpta facilities.”

Going Non-GMO: Be Realistic-and Start Early

How to Source Non-GMO Ingredients and Suppliers

SunOpta’s manufacturing facility in Minnesota is the first to be PVP-verified for a non-GMO claim by the USDA.

USDA Verifies First Company Non-GMO Claim

With 20 studies on probiotic strain Ganeden BC30 under the belt of Ganeden Biotech (Cleveland, OH), why not go for 21? Well, now Ganeden has.

On May 7, the company announced the results of the 21st study on Ganeden BC30, which explored the proprietary probiotic strain’s effects on digestive and immune health in healthy seniors. The study found that daily consumption of Ganeden BC30 (

GBI-30, 6086) significantly increased populations of 

a strain of beneficial bacteria linked to gastrointestinal health-as well as reducing a cytokine linked to reduced inflammation throughout the body.

The double blind, placebo controlled, cross-over study involved 36 participants aged 65-80 in generally good health and free of any gastrointestinal illness. The participants were randomly assigned to receive either 1 billion CFU of Ganeden BC30 or a placebo to take in daily capsule form for 28 days. At the completion of the first treatment, participants underwent a 21-day washout period before switching to the other treatment for another 28 days. Blood and fecal samples were collected at the beginning and end of each treatment period.

Compared to the placebo treatment, researchers found that consumption of Ganeden BC30 led to a greater increase in populations of 

 in participants. A blood analysis also revealed an increase in anti-inflammatory cytokine IL-10 after treatment with Ganeden BC 30, with no such effect observed after placebo treatment.

As a result of their findings, the researchers concluded that “daily consumption of BC30 by adults aged 65-80 [years] can increase beneficial groups of bacteria in the human gut and potentially increase production of anti-inflammatory cytokines.”

The same population of participants were also used in a previous 

 study, which found that a combination of prebiotics and Ganeden BC 30 led to an greater increase in short chain fatty acids than when the prebiotics were consumed alone.

“Seniors have natural changes to the GI and immune system that are unrelated to illness, making them an ideal healthy population to study in order to show the benefits of a probiotic,” says David Keller, vice president of scientific operations, Ganeden Biotech. “This study in healthy adults supports both digestive and immune health claims for Ganeden BC30, and has helped us better understand how Ganeden BC30 can help with the effects of aging in the gut.”

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Michael Crane
Associate Editor
Nutritional Outlook magazine


The 21st study of probiotic strain Ganeden BC30 suggests significant digestive and immune benefits for healthy seniors.

Nutritional Outlook Vol. 18 No. 6