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From: Food Quality & Safety magazine, December/January 2013

Functional Ingredients Challenge Food Industry, Elevate Need for Public Standards

by Markus Lipp, PhD

Even as food companies rush to find exciting functional food ingredients, they face a number of challenges in characterizing and analyzing novel findings.

Functional ingredients in foods—marketed to improve cognition, enhance athletic performance, boost energy, aid in weight loss, or address other health-related conditions—are the innovative area in the food industry. The trend shows no sign of slowing down, buoyed in large part by an aging population seeking to stay active and healthy. Many of the ingredients being incorporated into foods are plant-derived—from the next super berry to the new groundbreaking no-calorie sweetener—further tapping into consumers’ growing desire for “natural” ingredients.

Manufacturers are responding accordingly—unveiling new products featuring these functional ingredients in just about every food category. Manufacturer excitement has been tempered, however, by growing regulatory scrutiny regarding the health claims they are making for these products. This includes the U.S. Federal Trade Commission, the FDA, and especially the European Food Safety Authority, with the latter seemingly expecting to see proof at the clinical trial level for most health claims. Regulators want to see these claims grounded in sound science.

But this is not just a regulatory compliance issue. Even without pushback from regulators, companies need to be concerned with their intellectual property as these ingredients grow in popularity. Many responsible companies are investing heavily in the functional foods category. However, this whole industry segment could be ruined by irresponsible suppliers or companies that either knowingly make false or misleading claims or neglect to do their due diligence—both of which can undermine the legitimate work underway and negatively impact consumer perception across the board.

To serve as a true resource for the food industry, many of the new standards being advanced through the U.S. Pharmacopeial’s Food Chemicals Codex are those ingredients that are of high interest to manufacturers and consumers.

From a scientific perspective, these functional ingredients present numerous challenges. Many offer promise, but questions remain about how they will work once they are incorporated into food products. There may be açaí berries growing in the jungles of Brazil (and recently also in China), but how do you get these berries out of the jungle and into a finished product? Given the transportation associated with complex global supply chains and processing conditions, along with numerous other variables involved in mass production of food, do the finished products still offer consumers the same benefits as they would enjoy eating the berries off the tree? Have they been altered in a way not visible to the purchaser through the addition of other, non-listed ingredients or the removal of valuable constituents?

An additional challenge is characterizing and analyzing these materials, particularly the ones that fall into the natural category, such as açaí berries, pomegranate juice, or stevia. This is far more difficult than characterizing something like table salt or Vitamin C—simple chemicals that involve relatively straightforward analytical work. Determining the identity of plant-derived functional ingredients is vital.

There may be a host of compounds present within an individual plant, with perhaps one in particular that shows some health benefit. Ensuring that you have captured that compound, as opposed to another in the plant, is important for connecting a product to the demonstrated health benefit or other desired function. In the case of plant-based, no-calorie sweetener stevia, for example, the most commonly used compound from the stevia leaf was initially rebaudioside A. But how would a manufacturer confirm it has procured high-purity rebaudioside A, as opposed to a mixture of rebaudioside B, C, D, E, F? These compounds are all present on the stevia leaves and have similar properties. Yet the desired sweetener taste profile will be different, and the regulatory approval of rebaudioside A may not extend to a mixture that includes the other compounds. How does a manufacturer confirm that it is sourcing what it expects?

Moreover, demonstration of a particular health or other benefit is often contingent on the quantity of the compound, making accurate measurement essential. This is the case with probiotics, for which digestive and other benefits are often clearly tied to microbe count (enumeration), in addition to the particular microbe strain.

The challenge of such measurement—and how a lack of consistency across the industry can undermine an entire category of ingredients—can be seen in the case of antioxidants. In the marketing of these ingredients/products, “antioxidant capacity” is touted. Yet, multiple methods to measure antioxidant capacity exist. These differ in their methodological approaches and deliver results that cannot be compared among methods. An added complication is that these methods are in vitro tests, and it remains unclear how to correlate such in vitro results to any in vivo effects. Today, antioxidant capacity has become an almost meaningless number, mostly due to industry disagreement over how this property should be measured and reported.

Even with all these challenges, the future of functional ingredients is not doomed. It is incumbent on us all to advance the science, however. The community as a whole—suppliers, regulators, manufacturers, consumers, and standards-setting bodies—must come together and make some decisions on the scientific foundation of functional ingredients and any associated health claims. The industry must come to a consensus on how to determine the identity of these innovative ingredients, as well as how to measure them. The more we look into nuanced effects, such as better vision or improved gut health, the more important this will be for everyone.

This is precisely where independent, unbiased public standards can play a key role. Through its Food Chemicals Codex (FCC), the U.S. Pharmacopeial Convention (USP) develops standards for the identity, quality, and purity of all types of food ingredients. Any food ingredient legally marketed anywhere in the world is eligible to be included in this compendium, and the USP generally works with a sponsor during standards development. To serve as a true resource for the food industry, many of the new standards being advanced through FCC are those ingredients that are of high interest to manufacturers and consumers. In the category of functional ingredients, these include krill oil, omega 3s, pomegranate juice concentrates, natural colors and sweeteners, and spirulina, among others.

The community as a whole—suppliers, regulators, manufacturers, consumers, and standards-setting bodies—must come together and make some decisions on the scientific foundation of functional ingredients and any associated health claims.

At present, USP standards can assist significantly in confirming the identity, purity, and other quality attributes of these materials, which are coming in from all over the world. However, some—if not most—of these novel ingredients may call for a unique approach, including potentially accounting for the functionality (health claims) of ingredients, a challenge not currently addressed by FCC standards. To explore the critical chemical, physical, and functional characteristics of food (and dietary supplement) ingredients and how to measure them—as well as the degree to which function or health claims is tied to the identity of these ingredients—the USP held its Science and Standards Symposia on this topic in the fall of 2012.

The symposia offered an important starting point for soliciting varied perspectives on some of the unanswered questions and exploring the role of public standards to help ensure the authenticity of these promising ingredients and to help bring consistency to the marketplace. Much work remains to be done, but through the FCC, the USP is considering a variety of ways to provide standards that will meet the needs of manufacturers, regulators, and, above all, consumers, who deserve to know that the products they purchase are not masquerading as something they’re not. More information on the FCC, including how companies can work with USP to develop standards for new ingredients, is available at

Markus Lipp, Ph.D., is director of food standards for USP.

When Health Benefit Claims Cross the Line FDA guidance offers limited insight on Functional Ingredients

When Health Benefit Claims Cross the Line FDA guidance offers limited insight on Functional Ingredients

Functional ingredients can easily cross the line when it comes to the regulatory scrutiny they attract. Over the years, the FDA has issued myriad warnings for ingredients that are either illegally marketed as drugs or are used in unsafe ways. For the agency, the effort to rein in unacceptable claims is a never-ending battle as marketers and food scientists continually push the boundaries, prompting regulators to take a closer look at novel products and the health benefits suppliers claim.

Regulating new ingredients and monitoring and assessing their health claims are difficult tasks as claims often blur the line between nutritional benefits and drug functionality. Additionally, concerns have been raised about commodity ingredients used in new products at levels that may exceed what is generally recognized as safe (GRAS) – such as the concentration of caffeine in new energy drinks.

Further adding to the regulatory complexity is a movement by some local authorities to limit GRAS ingredient intake. Two examples are a recent congressional inquiry into the safety of energy drinks when taken by children and New York City’s ban on large containers of sugary drinks. So even when the FDA has clear guidelines on what is acceptable and not, consumer and political pressures may lead the agency to take a second look.

But where does the agency draw the line on the benefits a functional ingredient can claim without violating the definition of a drug? In its guidance on complementary and alternative medicine (CAM) products, the FDA provides examples of how a functional ingredient may fall under the definition of CAM. For example, the guidance states:

“…if a person decides to produce and sell raw vegetable juice for use in juice therapy to promote optimal health, that product is a food subject to the requirements for foods in the [Federal Food, Drug, and Cosmetic] Act and FDA regulations, including the hazard analysis and critical control point (HACCP) system requirements for juices in

21 CFR part 120. If the juice therapy is intended for use as part of a disease treatment regimen instead of for the general wellness, the vegetable juice would also be subject to regulation as a drug under the Act.”

Similarly, the Act also makes clear how additives are defined as CAM products.

For instance, botanicals or enzymes added to foods may fall within the “food additive” definition under section 409 (21 U.S.C. 348) of the regulation, which makes it subject to premarket approval by the FDA. However, if it is considered GRAS by qualified experts, it is exempt. Any claims associating the substance with the reduction of a disease risk are considered health claims (defined in 21 CFR 101.14(a)(1)) that require premarket review by FDA.

The guidance also provides examples of how dietary supplements would be treated by the agency. It cites the example of a cranberry extract tablet used for urinary tract health. “…the cranberry tablets generally would be regulated as ‘dietary supplements’ under section 201(ff)(1) of the Act if they were labeled for use to ‘maintain the health of the urinary tract’ rather than ‘prevent urinary tract infections.’ The cranberry tablets would be regulated as ‘drugs’ under section 201(g) of the Act if they were labeled for use to ‘treat urinary tract infections’ even if they were labeled as dietary supplements.”

Although the guidance document provides several concrete examples of how ingredient manufacturers can market their products, the FDA also acknowledges it is unable to provide “detailed” guidelines for all food products. That means companies wanting to bring new functional ingredients to market must toe a blurry line that may or may not draw the scrutiny of the agency.



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