The American public is evolving again! A trip to the local vitamin store finds the supplement aisles symbolically quiet...a reflection of flat and, in some categories, declining sales. Prescription drug sales, in comparison, are up by 19%, according to the May 8, 2001 issue of the Wall Street Journal.

What just happened? Have Americans turned their backs on the more natural approaches to health and fitness that they pursued in the last few years? For those that champion the availability of a wide range of wellness products and the ability for consumers to take control of their own welfare, the current trend--at first look--appears grim. That is, until one takes a closer look at the consumption habits of LOHAS consumers.

Looking at LOHAS

LOHAS is an acronym for "Lifestyles of Health and Sustainability." According to the Green Money Journal, consumers in this market segment are concerned about issues that include human rights, fair trade, the environment, sustainable practices, as well as spiritual and personal development. The natural foods business is one of its sectors. Being a relatively new market segment would lead one to believe it's a small niche; however, sales have reached $230 billion in the U.S. and "50 million consumers are waiting to buy into it," reports Monica Emerich, director of research at Natural Business Communications. The "cultural creatives" that comprise the LOHAS segment make up 26% of American adults today. (See www.greenmoney.com/gmj/fall00/fall700.htm and http://www.naturalbusiness.com.)

LOHAS consumers helped drive the popularity of herbs and vitamins. Although these supplements still have a following, consumers have grown more cautious of new items trying to steal the spotlight as the "in" ingredient. They want products that work, that are convenient and that fit into a diet that provides health --without sacrificing the taste and experience associated with more traditional foods. "Functional foods" meet many of these criteria.

So what are functional foods? In their broadest sense, functional foods defined as "food items that provide a health benefit other than general nutrition" have been around for thousands of years. More concisely, the Institute of Medicine of the National Academy of Sciences defines functional foods as "foods to which the concentrations of one or more ingredients have been manipulated or modified to enhance their contribution to a healthful diet."

However, a legal definition of functional foods does not exist. That is, the FDA has not created separate legislation for this category. One result is that companies are confused as to the regulatory framework that guides these products. Uncertainty exists particularly as a product's characteristics blur between that of a traditional food or beverage, or a dietary supplement.

In an effort to clarify regulations, the FDA published a position letter entitled "Letter to Manufacturers Regarding Botanicals and Other Novel Ingredients in Conventional Foods" on January 30, 2001. Although gray areas remain, some of the most important distinctions are summarized below and also can be read in the chart titled "Functional Foods vs. Supplements."

Dietary supplements are governed by the legislation of the DSHEA (Dietary Supplement Health and Education Act). However, functional foods are considered foods and fall under traditional food product regulations.

Functional foods should be presented in the form of a conventional food, whereas supplements should be manufactured in forms characteristic of supplements, such as capsules, pills, liquid extracts, etc. This area is perhaps "grayer" than most.

Functional food ingredients need to be GRAS (Generally Recognized as Safe). This contrasts with supplements in that--according to the DSHEA--permissible ingredients are all of those that were on the market before 1994, or those that can demonstrate safety through Section 8 of DSHEA.

One other important clarification was made in the FDA letter regarding functional foods: structure function statements, which so far had only been permitted on supplements, are now permitted for functional foods. For information on structure function claims, see http://vm.cfsan.fda.gov/~dms/dsstruc.html.

One advantage of the blurred line between these two categories is that companies may choose which area their product best fits into and label accordingly. For example, Celestial Seasonings has two similar Green Tea products on the market, both named "Green Tea." One product is labeled as a supplement with a Supplement Facts panel and contains the non-GRAS botanical, Siberian ginseng; the other is labeled as a conventional food with a Nutrition Facts panel.

Probiotic Patterns

The Global New Product Database (GNPD) provides insightful trend information when key words such as "probiotic," "bifidus" and "lactobacillus" are used to gather a list of products containing these beneficial organisms.

Companies that promote probiotics on their labels are more international than those that tout the health benefits of soy protein. Other trends include an increasing tendency to also incorporate prebiotic compounds. Japan has traditionally lead this effort. Suntory's (Japan) Bikkle banana flavored dairy drink introduced this year contains xylo-oligosaccharide as well as bifidus. In the U.S., Stonyfield Farms (Londonderry, NH) is adding inulin to a number of yogurts, such as the Planet Protector brand. Planet Protector also shows the trend toward the addition of multiple cultures, as it lists the presence of S. thermophilus, L. bulgaricus, L. acidophilus, bifidus, L. casei, and L. reuteri.

Tallying associated health claims, the most popular are those that indicate the product is of benefit to regulating the digestive system, followed by claims that the product "strengthens the immune system." Products containing pre-biotics --that plug their ability to improve nutrient absorption-- are also appearing globally. Stonyfield's YoSelf is said to feature a dietary fiber clinically proven to increase calcium absorption.
­ Claudia D. O'Donnell

Natural Flavors with Medicinal Properties

Extract FEMA # Health Properties
Aloe 2047 Promotes wound healing, treats burns and skin irritation
Angelica 2087 Folk remedy for stomach cancer
Apricot 2105 Folk remedy for anemia, asthma, bronchitis and cold
Lavender 2619 Folk remedy for acne, colic, migraine
Licorice 2628 Estrogenic activity, anti-inflammation, anticancer
Orange peel 2824 Anticancer, antioxidant

Source: Professor Chi-Tang Ho, Dept. of Food Science, Rutgers University.

Natural flavors, as well as spices and herbs, contain healthful compounds that are supported by research to various extents. When plant-based ingredients are used as dietary supplements, the level of bioactive components in the product--that is, the dosage--is crucial to the supplement's efficacy. Current research with in vitro tests show that for crude spice extracts, at least, anticarinogeneis can be obtained with only a few ppm. - C. O'Donnell

Coming to Grips with GRAS

The concept of GRAS has been one of the more confusing regulatory topics for many companies, especially for those introducing food and beverage-type products with herbal ingredients.

On June 7, 2001, the FDA took its first steps of action against companies with botanical ingredients in functional beverages by issuing warning letters concerning Ginkgo, Siberian ginseng and echinacea. The FDA announced its plan to send more such letters to manufacturers throughout the following week as an effort to guard the "integrity of the food supply."

Ingredients that are GRAS are either approved by the FDA or self-affirmed. A list of GRAS substances is available on the FDA website http://www.access.gpo.gov/nara/cfr/waisidx_99/21cfr182_99.html. Recent self-affirmed GRAS ingredients include chitosan, which is used to reduce fat absorption from the gastrointestinal tract, and lutein, an antioxidant that some research has shown to be of benefit for reduced risk of degenerative eye conditions. Other such GRAS ingredients include gamma-cyclodextrin and diacylglycerol. Self-affirmed ingredients are not on the website list.

Companies may seek "self-affirmation" by going through the relatively new FDA notification process, designed to make "self-affirmation" of ingredients obtained more easily.

Functional Foods vs. Dietary Supplements
Functional Foods
Dietary Supplements
GRAS ingredients only Supplements on the market before 1994, or proof of section 8 safety; no need to be GRAS
Structure/function claims allowed (without disclaimer)* Structure/function claims allowed (with disclaimer)
Nutritional claims allowed Nutritional claims not usually used
In the form of a conventional food In the form of a supplement (capsule, tablet, liquid extract in dropper bottle, etc.)
Regulated according to existing food laws and GRAS; not a separate, legal category Regulated according to the Dietary Supplement Health and Education Act of 1994 (DSHEA)
Nutrition Facts box required Supplement Facts box required
*Source: Informal discussion by a FDA representative during a seminar held by Patton Boggs at Natural Products EXPO East, September 2000.


According to this process (see http://www.cfsan.fda.gov/~dms/opa-frgr.html and http://www.cfsan. fda.gov/~rdb/opa-gras.html), ingredients may become GRAS through one of two routes: (a) scientific procedures or (b) a "substantial history" of "significant food" use. Route (a) takes essentially the same amount of evidence that is required for establishing an ingredient as an approved food additive...or, as one industry insider puts it, "enough scientific evidence to choke a horse." The opportunity for most botanicals lies in route (b). In looking at the three herbs--echinacea, Siberian ginseng, and Ginkgo leaf--that the FDA chose as examples in their warning letter on botanicals in functional beverages, none have substantial use as pure foods.

Thus, botanicals will most likely be included as "legitimate" ingredients in functional foods if they are already on the GRAS list, or if they can be affirmed due to historical food use. However, challenges and questions exist for both avenues. For GRAS-listed botanicals, for example, the particular application is critical. St. John's wort is listed as GRAS, but only for use in alcoholic beverages as a flavoring, and then only as an extract that is hypericin-free. On another note, if there's interest in using a structure function claim with the product, the supporting scientific evidence must be gathered.

Certain "novel" botanicals may appropriately be used in functional foods if they have traditional use as foods. The voluntary but burdensome step of filing a GRAS notification should be taken. To be diligent in its product development efforts, a wise company works to assure that the FDA understands its reasoning.

Chrysanthemum (Dendranthema morifolium), long used in beverages in China and also as a traditional Chinese medicine, is an example of such a botanical that has gone through the notification process. However, many "food" botanicals are not as well-recognized by the public--such as popular herbs like echinacea. (See http://www.cfsan.fda.gov/~rdb/opa-g013.html).

Soy and Heart Health Claims

The food industry is taking advantage of the FDA-allowed health claim that links the consumption of soy protein with a reduced risk of coronary heart disease. (See the website http://vm.cfsan.fda.gov/%7Elrd/tpsoypr2.html.) However, not in the formal way that the FDA had perhaps intended.

Within the last few years, Mintel/NPN's Global New Product Database, Chicago, has increasingly gathered nutritional and ingredient legend information on new products introduced around the world. Using the key search words "soy," along with "heart" and "cardiovascular," a list of 34 food products introduced into the US since mid-1998 was derived. Most products are relying on the "halo" effect of the actual claim. For example, Franklin Farm's (North Franklin, Conn.) Chicken Flavored Vegetarian Nuggets touts the presence of Heart Smart soy protein. Naturade's (Irvine, Calif.) promotes its Total Soy beverage contains 50% of the soy protein needed daily (6.25gm by regulation) to reduce the risk of heart disease. ProLab Nutrition's (Bloomfield, Conn.) Cory Everson's soy protein bars note they promote strong bones and maintain a healthy cardiovascular system.

Not all companies are so shy, however. Ross Products (Columbus, Ohio) is among the few companies who clearly references the FDA soy protein claim on their Ensure Cholesterol Wise beverage and bar line.

­ Claudia D. O'Donnell, Sr. Technical Editor

Following are several other botanicals with traditional food uses, excerpted from the EthnoPharm Food Use Database on the web at www.ethnopharm.com.

Maca (Lepidium meyenii) is grown widely in the Andes as a staple crop and is gaining popularity in the U.S. as a supplement for its invigorating properties. Nopal (Opuntia streptacantha) has been used by Latino and Native American populations in Mexico and in the U.S. as a food. It's gaining popularity as a supplement for diabetes and lowering cholesterol.

Saw Palmetto (Serenoa repens) is used by Native Americans as a food and is also one of the most popular U.S. herbal dietary supplements used for prostate health. The Hawthorn berry (Crataegus laevigata) is used in Europe in jams and jellies and is also becoming a popular herb in the U.S. for cardiovascular health. Reishi (Ganoderma lucidum) is a mushroom used by the Chinese both as a traditional medicine and as a food.

Types of Nutritional Ingredients

Ingredients that are added to functional foods are broad-ranging and could be placed into several categories. Some of their basic definitions and examples are outlined below:
  • Botanicals. Functional ingredients that are derived from a specific plant as a crude or heterogeneous mixture of naturally occurring compounds. They can be herbs, spices, or fruits considered GRAS, such as ginger, licorice and chamomile.
  • Proteins and Amino Acids. Amino acids are the building blocks of proteins and are characterized by the -NH2 amino group. Examples of amino acids that are used in functional foods are taurine and L-carnitine.
  • Probiotics and Prebiotics. They are live human-derived microorganisms (such as bifidobacteria and Lactobacillus species) that, upon ingestion, are thought to confer a variety of health benefits. Prebiotics are non-digestible food ingredients that help maintain the presence of beneficial intestinal flora. Examples include inulin and oligofructose.
  • Vitamins and Minerals. Vitamins are organic substances that are required for the normal metabolic functioning of the human body, and thus have Recommended Daily Allowances. Minerals are inorganic substances and not all have RDAs.
  • Antioxidants. Substances with the ability to "inhibit" the actions of free radicals. Botanicals, vitamins, or purified natural compounds like the bioflavonoids and increasingly popular procyanidins exhibit antioxidant activity.
  • Nutritional Lipids. Fats or fatty acids with health-promoting properties. Gamma-linolenic acid, fish oil, and flax seed oil are examples of popular nutritional lipids.

As consumers and media became disillusioned by dietary supplements, so too can they become disillusioned by functional foods. For example, when botanicals are used in functional foods, most companies use very weak and/or low quality extracts. According to Jeff Wuagneux, president of RFI, developers are shopping for price, and are sacrificing function (by using low potency extracts) for taste.

Functional food regulations will gradually be clarified--from an ingredient's GRAS status, to the amount needed to be efficacious, to the science needed to support a structure function statement. However, the industry still must develop safe and quality finished products that live up to their label claims. Unless companies offer products that live up to consumer expectations, functional foods will suffer the same fate as supplements. PF