Natural Foods Merchandiser

FDA Ferrets out Fakes Among Functional Waters

There's Water Joe to wake you, Skinny Water to slim you, Miracle to rehydrate you and Propel Fitness Water to energize you. American consumption of bottled waters tripled in the last decade, and waters are the fastest-growing segment of the $7 billion per year beverage market. Water has gotten much more complicated in the last two years—in terms of product development, manufacturing, labeling and marketing.

Functional waters cascaded into the market during the last two years. Some are geared to athletes and sports enthusiasts, some to dieters, many to women, most to baby boomers and others to 20-somethings. Many, like Results for Women from EAS, include electrolytes. The theory is water is an efficient delivery system for getting various nutrients into the body. Recently, Nico Water, a smoking cessation product, was introduced and pulled off the market as fast as the U.S. Food and Drug Administration could say "unapproved new drug."

I call these enhanced or infused waters functional waters by analogy to functional foods, yet there is no legal definition of functional foods, and the FDA does not recognize functional foods as a separate category in its regulatory framework. Functional is a marketing term.

Recently the industry has witnessed double agency scrutiny over promotional claims contained in company Web sites.
In July 2002, the Government Accounting Office issued the report "Food Safety: Improvements Needed in Overseeing the Safety of Dietary Supplements and Functional Foods." It recommended the FDA require functional foods meet major provisions of the Dietary Supplements Health and Education Act, and the FDA develop and implement a strategy for addressing unsupported structure/function claims used for functional foods. The latter has been accomplished, not the former.

There are two official categories to choose from—conventional food or dietary supplement—and the FDA's position is that no hybrid labeling is allowed. Thus, functional waters must either be foods or supplements. If manufactured, labeled and marketed as a food, a functional water implies the following regulatory issues:

  • Any added ingredient must be either GRAS (generally recognized as safe, such as ginger, spearmint, vanilla or turmeric) or an FDA-approved food additive. No shark cartilage need apply.

  • The product must be consistently labeled as a food, with an acceptable Statement of Identity on the front panel identifying the product as a water or beverage, and with a Nutrition Facts box in the information panel.

  • Technically, structure/function claims are permitted only for dietary supplements, with claims for foods restricted to taste, aroma and nutritive value.

  • Any health claims used must be authorized by the FDA, such as the health claim linking calcium to a reduced risk of osteoporosis. (See NFM's November 2002 Counselor's Corner column for more on the soy health claim.)

  • The FDA has issued several warning letters and an open letter to the industry concerning beverages containing novel ingredients, including herbs. In addition to the GRAS requirement and the prohibition on unauthorized claims mentioned above, the FDA has safety concerns.

If manufactured, labeled and marketed as a dietary supplement, a functional water brings about a similar set of regulatory issues:

  • Dietary ingredients on the market as a food or supplement before October 1944 are exempt from GRAS and from the food-additive requirement that applies to foods.

New dietary ingredients must meet the requirements of Section 8 of DSHEA, and evidence of a reasonable expectation of safety for the new ingredient must be submitted to the FDA.

  • The product must be consistently labeled as a supplement, meaning it must include an acceptable statement of identity on the front panel identifying the product as a dietary supplement or herbal supplement, or similar name, and a supplement facts box.

  • Structure/function claims such as "strengthens the immune system" are permitted, but must be accompanied by the DSHEA Section 6 disclaimer, which says the statement has not been reviewed by the FDA.

  • Disease claims, expressed or implied, are not permitted, including disease claims in the product name. For example, an antioxidant water may not be called Cancer Cleanse.

  • As in waters marketed as beverages, unauthorized health claims for functional waters are not allowed. For example, though some evidence links lycopene to reduced prostate cancer risk, this is not an FDA-authorized health claim, so neither the makers of V8 Juice nor of a Lycopene Water may make this claim.

The FDA will take issue with water products sending mixed messages to consumers, such as those that are presented and labeled as foods, include a nutrition facts box, yet also contain structure/function claims on the label. In short, a product can't have it both ways. For instance, a warning letter was issued to the makers of a functional cereal alleging misbranding, in part, because the product was clearly represented as a conventional food, yet used "An Herbal Dietary Supplement" in the statement of identity. The label also contained structure/function claims about sustaining good memory, which went beyond statements of nutritive value.

Warning letters are significant enforcement actions with important consequences—at the very least, relabeling of the product, sometimes including inventory. A response is typically required within 15 business days. At worst, as the warning letter concludes: "You should take prompt action to correct these deviations and prevent their future recurrence. Failure to make prompt corrections could result in regulatory action without further notice. Possible actions include seizure and/or injunctions."

Regulations governing use of the terms enriched and fortified with are 21 Code of Federal Regulations § 101.54 and 21 CFR. § 101.13. The FDA interprets use of these terms as a nutrient content claim to mean "more," which in turn imposes requirements that the food contain a certain level of that ingredient or nutrient. Another part of the code consists of regulations governing the fortification of foods, and fortified with claims. So what may seem merely a marketing term to a promoter or retailer is actually a nutrient content claim with specific regulatory requirements.

For example, the FDA sent a warning letter to the manufacturer of Rock 'n Roll Fitness Water Enhanced Water Beverage (name changed) stating this product description, in conjunction with various vitamins and minerals highlighted on the front panel of the bottle's label, rendered enhanced an unauthorized synonym for the nutrient content claim "added ____." The regulations define the claim added to as meaning the food contains 10 percent or more of the Reference Daily Intake of vitamins or minerals or 10 percent of the Daily Reference Value of protein, dietary fiber or potassium per Reference Amount Customarily Consumed. Thus, this product was mislabeled, or misbranded.

Similar action was taken against a product I will call Fresh Frances. The label claims "with echinacea" and contains echinacea as nutrient content claims, implying the food contained 10 percent to 19 percent of the RDI or DRV of the RACC. Yet there is no RDI or DRV for echinacea (it's not an established-value nutrient, such as a vitamin or mineral), so the claims were unauthorized and thus misbranded the product.

The Federal Trade Commission governs and monitors promotional claims for such products. Recently, a new subfield has emerged called oxygenated waters. For example, BEVsystems International markets LifeO2 Super-Oxygenated water, boasting up to 1,500 times more oxygen than regular water. Skepticism from the scientific and medical community, as well as common sense, raises questions. Although oxygen can be infused into water, according to some researchers, it does not enter the bloodstream by ingestion. Seller beware: Four years ago, FTC took action against the marketers of Vitamin O, who claimed humans need extra oxygen as a supplement, carried via a capsule. There was no scientific substantiation for the claim.

The FDA and the FTC have joint jurisdiction over products such as functional waters, and recently the industry has witnessed double agency scrutiny over promotional claims contained in company Web sites. Also, retailers should ensure their shelf-talkers, distributors and promos do not indicate a drug or therapeutic intended use for the water.

In addition, some consumer protection groups are monitoring functional beverages. In July 2000, the Center for Science in the Public Interest formally petitioned the FDA to take action against companies whose products contained non-GRAS herbs or unapproved food additives. In early 2001, the Council of Better Business Bureaus initially asked the FDA to investigate possible false advertising of Arizona iced teas, objecting specifically to Rx Memory Mind Elixir, which contained ginkgo biloba. The consumer group called it "an archetypal example" of drinks with herbal ingredients that imply unrealistic or unmet health benefits. These actions eventually led to three warning letters concerning such beverages, and to the FDA open letter to the industry.

Finally, some nutritionists are concerned about new functional waters. Many waters with added nutrients in 36-oz. containers are meant as two or more servings. Yet consumers who drink an entire bottle and also take supplemental vitamins in capsule form may overdose on particular vitamins, such as vitamin A. For these reasons, we may see an FDA policy or guidance document as to functional waters in the future.

So, functional water as food or supplement? In most cases, the choice is the manufacturer's, and the floodgates for this market and the sports supplement market are still wide open. As long as the specialized water is in full compliance with either the food regulations or the dietary supplement regulations (but not both), this is an attractive emerging product opportunity.

Susan Brienza is an attorney in the Denver office of the national, Washington, D.C.-based law firm Patton Boggs, LLP. She specializes in regulatory compliance, food and drug law and FTC law.

Natural Foods Merchandiser volume XXIV/number 3/p. 84, 86

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