Functional foods

For as long as most of us can remember, our mothers have admonished us to eat an apple a day to keep the doctor away. This sage advice is taking on new meaning, especially as researchers discover new insights into various nutrient functions.

Few doubt the public will turn down functional foods. Consumers equate a good life with a good quality of life, states Susan Borra, vice president of the International Food Information Council (IFIC), Washington, D.C.

The results of a study conducted for IFIC reveal that many consumers feel eating healthy is too time consuming and/or too expensive. Consumers say they are too busy to give much thought to planning their meals in advance. They will focus on eating better tomorrow or the day after - or whenever things slow down. In the meantime, their lifestyle creates gaps. "They want to fill these gaps with fortified products and supplements," states Borra.

The prevailing wisdom? Consumers will adopt functional foods, especially if it means they have to make few, if any, lifestyle changes. The market for these foods is growing at an exponential rate. One estimate is that by the end of 2000, there will be a 30% increase in the demand for foods targeted to special needs.

Yet as researchers discover ways to create these new foods, they are faced with a number of questions. How can these foods be used safely by the public? How can these foods be promoted? Are these new foods a food or a drug? Such considerations fall into the regulatory realm, and as such, the FDA and other government agencies are investigating ways to answer these questions.

Many of us are used to turning to the government to help define food products. However, consulting the Food Drug and Cosmetic Act will not yield a definition for functional foods. Further searches of federal regulations also come up empty. "Functional foods - nutraceuticals, pharmafoods, designer foods - are all marketing terms," says Elizabeth Yetley, Ph.D., director of the FDA's Office of Special Nutritionals.

These terms, notes Kevin Krail, general manager of functional foods business development for H.J. Heinz Company, Pittsburgh, describe foods with health benefits beyond basic nutrition. This differs from fortification, which is the addition of basic nutrients, such as vitamins or minerals, to a product to increase the nutrient value. Often, fortification brings vitamin and nutrient levels back up to a product's pre-processing levels, or adds a nutrient, such as iodine, that much of the population lacks.

So, how should foods that go beyond basic nutrition to confer beneficial effects, such as disease resistance, be regulated? According to the FDA, the agency currently does not have the authority to regulate these new hybrid "functional" foods. The agency contends that it cannot act until Congress passes a bill charging the agency to take action; to date, Congress has not recognized that foods can have a therapeutic or restorative effect.

Others, especially food and drug lawyers, totally disagree. They claim that the FDA currently has more than enough authority to regulate these foods. The agency just has to take a closer look at current regulations, some say. And, they point out, there's precedence for the agency to develop regulations in areas for which they do not have statutory authority - medical foods and dietary supplements, for example.

The way the FDA regulates functional foods will depend on how the food is marketed - the claims made, the words used by the manufacturer and their intended use, says Scott Bass, attorney in the Washington, D.C. office of Sidley and Austin. They could be regulated as drugs, dietary supplements, food ingredients or medical foods. What matters in the regulatory arena is the intended use of the food, explains Bass, coupled with what the public believes the food to be.

Whichever way the food is marketed, says Bass, the FDA will ask a number of questions. Does it pose a hazard? Is it sold in a conventional market? Is it sold in a limited, controlled market? How does the public perceive the product? Lastly, is the manufacturer trying to do an end run around existing regulations? Is the food really a drug masquerading as a food? There are many factors involved, but what is clear is that the FDA will look at each functional food on a case-by-case basis.

"The intended use will determine how the food is regulated," states Bass. "The answer depends on the marketing position, which gets you back to the research and development of the product." Products might be marketed in one of the following ways:

If, for example, explains Bass, a manufacturer of a food makes a disease-treatment claim, in essence, the food is a drug. In this scenario, the food then could be regulated as a drug. However, he says, the developer may not want a drug claim if there is a healthful benefit in the food. Foods often have a lower potency claim than drugs. Also, safety standards are different for drugs than foods, says Bass. The drug standard, for example, measures the benefit vs. the perceived or actual risk.

Medical foods are defined in the Orphan Drug Act (21U.S.C.360ee(b)(3)). A medical food is a food that is formulated to be consumed or administered enterally under the supervision of a physician, and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.

If the manufacturer makes a claim that the food is a fortified food with a novel ingredient, then it is regulated as a food additive, states Bass. The safety standard used is whether or not there is reasonable certainty of no harm existing under the intended use of the ingredient. The food additive regulations may be the easiest for developers to comply with.

Lastly, manufacturers can claim the food is a dietary supplement. Under the Dietary Supplement Health Education Act (DSHEA), the FDA is charged with determining whether the supplement is harmful. The standard is "significant or unreasonable risk of injury." Herbal medicines are marketed as dietary supplements - i.e., foods - even though they function as drugs, explains Bass. "There is no scientific basis to distinguish between herbs and drugs."

Conventional foods and dietary supplements may make the following health claims according to 21CFR101, as long as they meet specific nutritional criteria related to fat, sodium and certain other nutrients:

In addition, DSHEA permits dietary supplements to bear "structure/function" claims - claims that the products affect the structure or function of the body - without prior FDA review. They may not, without prior FDA review, bear a claim that they can prevent, treat, cure, mitigate or diagnose disease (a disease claim). The FDA published its final rule that defines the type of statements that can be made in the January 6, 2000 Federal Register, which became effective 30 days after the date of publication.

These recently instated rules, however, which were designed to allow manufacturers more leeway for promoting their products without prior agency approval, are currently under scrutiny. Critics are concerned about the problems that may ensue if untested products are promoted for their effects on pregnancy related conditions. The FDA plans to review the policy, as well as hold a public meeting before providing further guidance. In the meantime, manufactures are advised to hold off on making any claims about a product's effects on pregnancy.

A manufacturer that chooses to have the active ingredient in a functional food treated as a food additive with a novel use must address any safety issues. A food is considered unsafe if it contains a substance that makes it unsafe. Food additives are presumed not to be safe, especially without a history of use. They may render injury to health through organ toxicity, adversely affect reproduction, or be carcinogenic.

If a developer can publicly document that the product has been consumed, that the range of consumption is the same historically, and that the literature does not indicate adverse effects, then the substance can be considered GRAS.

How the FDA ultimately decides to approach the safety issues of functional foods is only one piece of the puzzle, according to some in the industry. "The manufacturer has to address all the safety issues needed to protect the public and protect the company and its stockholders," says Richard Lane, Ph.D., director of scientific affairs for Lipton, Englewood Cliffs, NJ. In addition, notes Bass, the manufacturer must also make sure that the entire product, functional ingredients included, is stable over its shelf life.

"In functional foods," states Sanford Bigelow, Ph.D., director of regulatory affairs, medical foods, for Columbus, Ohio-based Ross Products, "GRAS is relevant, especially for new dietary ingredients. The standard should also consider safety within the context of the entire diet."

Some developers are working with concentrated extracts, says Bass. These extracts are typically used for flavoring purposes but could also enhance the nutritional composition of a food. Concentrated spice extracts of ginger and nutmeg have GRAS determination for flavor uses, but other uses might need to be GRAS-approved. Their intended use in intermittent and low-level dosages for flavors might not necessarily apply when they are used at the much higher levels that might be needed in a functional food.

"The developer should test the formulation for its intended commercialization, taking into account toxic doses," continues Bigelow. The tests should provide evidence of an adequate margin of safety, much like those for food additives.

Clinical data, states Bigelow, should be strong enough to allow the developer to make efficacy claims, using the most valid endpoints. The dose and duration should be tested in animals. Animal studies should always precede human trials, if human trials are needed to establish safety. One compelling reason for human trials is that the effects in animals don't necessarily translate into humans.

"The quality and quantity of the evidence must be mature, and the specificity of the claim made by the developer must be truthful and not misleading. The data needs to be strong and conclusive," emphasizes Bigelow. "There is no substitute for good science," he maintains.

"Promoting functional-food qualities is not a simple process," says Krail. "Traditional food companies want to respond to consumer needs. The media will cover the functional aspects whether we like it or not."

Before a manufacturer even advertises a functional food, it needs data to support the claims, says Michelle Rusk, staff attorney in the division of advertising practices of the Federal Trade Commission (FTC) in Washington, D.C.

Under FTC and FDA laws, a manufacturer may promote a food with a healthful quality, as long as the promotion material is truthful and not misleading.

"The science standard is flexible, but the science must be competent and reliable," emphasizes Rusk. Competent and reliable means that the tests, research and analysis are done by experts in the particular field, that the methodology is good, and that it is viewed by other experts. Another important criterion - the results can be replicated by others using the same methodology. The best research, of course, is peer-reviewed and published in a respected scientific journal.

When evaluating a claim, the FTC looks at data from a number of sources and will consider data from animal studies and in vitro lab studies. Obviously, says Rusk, the best data comes from human clinical trials. If a developer does not have the human trials, there must be a compelling reason why, he explains. However, human trials may be difficult or expensive to conduct.

The results of the studies, notes Rusk, must be statistically significant and clinically meaningful. The research and conclusion must match the claim. A product that is marginal for statistical significance and clinical effectiveness will not pass muster, and its labeling and promotion would likely be considered untruthful and misleading. Under no circumstances will FTC consider anecdotal evidence, emphasizes Rusk.

The courts, says Frederick Degnan, partner in the Washington, D.C. office of the law firm King & Spalding, state that promotional information can be misleading if it omits material facts. The Supreme Court reaffirmed this recently in its Pearson vs. Shalala ruling, a case involving promotion of dietary supplements. Furthermore, the Court said the manufacturers had no constitutional right to mislead the public, reaffirming that commercial speech is relevant to product promotion.

One thing is clear - once functional foods hit the market, manufacturers and developers need to educate the consumer on their use, actions, adverse reactions and contraindications.

"The effects of these foods do need to be known, especially as more and more people self-medicate," points out Lane. These programs do need to stress that consumers should inform their physicians of what they are doing. There could be various supplement/supplement interactions, food/drug interactions, or supplement/drug interactions. Developers shouldn't assume that self-medication isn't an issue, he notes.

From definitions and dosing to label claims and education, product designers may very well have a rocky road ahead when it comes to functional foods. But given their potential, dealing with functional foods' regulatory issues should be a small price to pay in return for the rewards offered by developing these products.

Joan Murray is president of Murray Enterprises, Arlington, VA, a foodservice consulting firm specializing in nutrition and menu development.