Dietary Fads and Frauds 0

ucts in any material respect. The Mail Order Consumer Protection Amend-
ments of 1983 enhance the effectiveness of the false representation statute
and are designed to address the problems of repeat offenders and "fly by
night" promoters who advertise a product, take orders, receive payments,
and change addresses without delivering any merchandise (Nelson 1984).
This new legislation gives the USPS authority to purchase and test without
delay any products or services sold through the mail. The 1983 amend-
ments also authorize the USPS to issue cease-and-desist orders. Such
actions, however, are limited by the validity of the address given by the
manufacturer. A growing number of promoters are advertising toll-free
telephone numbers and then delivering products using private parcel deliv-
ery services that are not under the USPS jurisdiction (Debrosse 1984).

Upon showing probable cause that a scheme violates the false representa-
tion statute, Federal district courts can order the Postal Service to detain
mail. Apparent violations of the postal fraud and misrepresentation statutes
are investigated by the Postal Inspection Service. Suspected criminal
violations are referred to the appropriate U.S. attorney.

Federal Trade Commission Authority. The FTC's authority to act against
deceptive food, drug, or other health claims derives from sections 5 and 12
of the Federal Trade Commission Act. Section 5 of the Act identifies
unlawful, unfair, and deceptive acts and practices in or affecting com-
merce. Section 12 of the Act specifically prohibits the use of false adver-
tisements regarding food, drugs, devices, or cosmetics. The Commission
can act under one or both sections to halt certain food, drug, or other health
care acts or practices.

Deceptive as well as fraudulent food, drug, and health care advertising
claims that induce people to purchase ineffective cures and nostrums are
important areas of FTC enforcement activity (Crawford 1984). A special
effort has been instituted to monitor claims for health care products, many
of which may fit into the fraud category. The FTC has implemented special
programs to monitor the advertising of some types offraudulent products in
tabloid publications and health magazines directed toward nontraditional
disease treatments. The FTC also monitors radio and television networks
and major newspapers and magazines to identify targets for Commission
action. Such targets are also identified through ongoing contacts with other
State and Federal officials and private groups.

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Key Issues

o Health Consequences of Fraud
o Economic Consequences of Fraud

Purveyors of nutrition fraud capitalize on people's desire to be healthy and
on the lack of certainty in many areas of nutrition and health. Although the
public may be injured by deceptive food claims, there are no reliable
statistics on the extent of health and nutrition fraud in this country (Young
1984).

Health Consequences of Fraud

Nutrition fraud may lead to deleterious health consequences, caused by the
failure to seek legitimate medical care, by potentially toxic components of
foods and products, by nutrient toxicities and deficiencies, by diversion of
monies from essential treatments, and by interference with sound nutrition
education.

Failure to Seek Legitimate Medical Care
Public health and safety can be jeopardized by false promises that divert or
deter individuals from pursuing sound forms of medical treatment or that
encourage them to abandon beneficial therapy for a disease (McBean and
Speckmann 1974). Fraud may encourage people to reject legitimate medi-
cal advice and to practice inappropriate self-medication that is less likely to
be helpful, and more likely to be directly harmful, than medical technology
based on a sound understanding of human biology and nutrition.

The FDA's annual reports document numerous instances of fraud-induced
failure to obtain appropriate health care (Young 1985). Because early
detection and treatment improve the prognosis for many illnesses, un-
proven "nutritional" therapies may unnecessarily delay beneficial inter-
vention (Brown 1984). Some diet regimens recommended by health fad-
dists to treat cancer, for example, are so nutritionally deficient or toxic that
adherence to them has caused death or serious illness (U.S. Congress
1984b). Although evidence is increasing that a proper diet may reduce the
risk of developing some forms of cancer, no diet or supplement can yet be
guaranteed to protect against-or to treat-these conditions.

Promotions of foods designed to treat various disorders are often targeted
to vulnerable populations (U.S. Congress 1984a). The use of these food

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Dietary Fads and Frauds 0

products accomplishes little besides increasing the market share of the
company making the fraudulent claims.

Potentially Toxic Food Components

Public injury can occur when foods and unproven remedies are toxic. Just
because a substance occurs naturally in food does not mean that it is
necessarily safe (Herbert and Barrett 1981). Many of the chemicals known
to be present in herbs, for example, have never been tested for safety
(Larkin 1983). Some plant foods contain potentially unsafe, pharmacologi-
cally active ingredients such as aflatoxin, one of the most potent carcino-
gens known. Few buyers are aware of the harmful components in these
products (Anonymous 1979).

There has been a substantial increase in the use of herbal products (Siegel
1976) that may contain pharmacologically active ingredients that can possi-
bly produce undesirable effects such as an increase in blood pressure
(Brody 1978). Occasional poisonings and clinical intoxications are reported
after the use of herbal tea products (Huxtable 1980; Siegel 1976; Larkin
1983). Ginseng, one of the most popular herbs in the United States, has
been reported to produce estrogen-like effects in some people (Siegel 1979;
Greenspan 1983). From present evidence, it cannot be concluded that all
herbal products can be consumed safely over extended periods of time
(Larkin 1983).

Potentially harmful ingredients have been identified in samples of other
food supplements, such as an estrogenic hormone in commercial alfalfa
tablets (Elakovich and Hampton 1984), arsenic in kelp tablets (Walkiw and
Douglas 1975), and cadmium in dolomite (Boulos et al. 1983). Potentially
toxic amounts of lead in bonemeal and dolomite have caused the FDA to
caution against use of these products, particularly by pregnant women and
young children (FDA 1982).

Nutrient Toxicities and Deficiencies

Frauds and fads may induce nutrient toxicities or deficiencies (Henderson
1974). Many people take vitamins as self-medication for the prevention or
treatment of health problems (Levy and Schucker 1987). An estimated 40
percent of U.S. adults consume vitamins, minerals, and/or miscellaneous
dietary components as supplements. The use of these products varies with
such demographic factors as geographic region, education, income, and
race. Women are more frequent consumers than men. Intake ranges wide-
ly, extending up to 10 to 50 times the Recommended Dietary Allowance

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CT1 Nutrition and Health

(RDA) for individual nutrients (Stewart et al. 1985). Data from the National
Health and Nutrition Examination Survey suggest that individuals with
better nutritional intake patterns are the predominant users of supple-
ments. Thus, supplement users may not be the individuals most in need of
them (Shank and Wilkening 1986).

Nutrient supplements are usually safe in amounts corresponding to the
RDA, but the RDA's are already set to provide maximum benefit consistent
with safety. Thus, there is no reason to think that larger doses will improve
health in already healthy people, and excess intake can be harmful. Mega-
dose intakes (often defined as 10 or more times recommended levels) can
have seriously harmful effects (Rudman and Williams 1983; Herbert 1980;
Dubick and Rucker 1983a). The toxicity of high dosages of vitamins A and
D is well established (DiPalma and Ritchie 1977). Although water-soluble
vitamins are relatively nontoxic, some of them also are reported to produce
toxic effects at high doses (Alhadeff, Gualtieri, and Lipton 1984). Because
the margin is narrow between a safe and a toxic dose of most trace
elements, excessive supplementation with these substances may be partic-
ularly hazardous.

Excessively restrictive dietary practices can also induce serious medical
problems or even death. Popular weight reduction products, for example,
provide very low daily calorie intakes (Newmark and Williamson 1983b).
Because such products have been associated with the deaths of some young
women, the FDA now requires warnings on labels to alert consumers of the
potential of such products (FDA 1984).

Many popular diets are potentially harmful because they eliminate food
groups or severely limit food variety (Council on Foods and Nutrition 1973;
Barrett 1981; Willis 1982). Examples include the Atkins, Stillman, and
other weight reduction diets that drastically reduce carbohydrate intake
and the Beverly Hills Diet, which advocates excessive fruit consumption.
Fad diets seldom produce long-lasting weight control (Newmark and Wil-
liamson 1983a). Highly restricted diets, such as the more extreme forms of
Zen macrobiotics, have led to nutritional deficiencies, starvation, and even
death in a few individuals (Council on Foods and Nutrition 197 1; Newmark
and Williamson 1983a). Such diets also have been associated with retarded
fetal development and childhood growth or other nutritional problems in
young children (Dwyer et al. 1983).

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Interference With Sound Nutrition Education

Commercial interests have capitalized on a heightened public awareness of
nutrition and health issues, but much of the public cannot evaluate the
validity of available weight reduction schemes, supplements, and services
(White and Selvey 1982). Self-appointed health and nutrition advisors have
expressed distrust of proven public health measures such as fluoridation
and pasteurization and, instead, have promoted treatment alternatives that
are not supported by accepted medical practice (Jarvis 1983). The public
also may be misled by extravagant claims of health benefits from the use of
certain foods or nutrient supplements (Council on Scientific Affairs 1979;
White and Selvey 1982).

Economic Consequences of Fraud

Impact on Consumers

People experience economic injury when purported remedies and cures do
not work, are untrue, or are greatly exaggerated or when purchased prod-
ucts are not needed. Fraudulent products are known to be extremely
profitable for those who sell them. A 1984 report by the Subcommittee on
Health and Long-Term Care of the Select Committee on Aging, for exam-
ple, stated:

. * . the practice ofquackery . . . now invades nearly every aspect of our lives,
and, at points, attracts adherents with . . . a keen sense of the vulnerability of
potential customers, the limitations ofthe law and the profitability of exploiting
both. Quackery has become big business. Twenty-five years ago, quackery
was said to cost $1-2 billion a year. Today, it probably totals at least $10 billion
(U.S. Congress 1984b).

This estimate is probably conservative because it does not include the sales
of weight reduction pills and diet cures, which alone are estimated to cost
$5 to $6 billion yearly (Halamandaris 1984).

Many fraudulent products and services can be very costly yet are promoted
as having nutritional or health benefits that have not been substantiated in
the scientific literature (Meister 1984; Dubick and Rucker 1983a, 1983b;
Herbert 1980; Larkin 1984; Anonymous 1985). Examples include:
o Superoxide dismutase (SOD) and nucleic acids (RNA and DNA) as
  antiaging remedies.

o Bee pollen as a source of youth and health and as an energy pill for
athletes.

705


O Nutrition and Health

o Lecithin in combination with vinegar, kelp, and vitamin B, for the

prevention and cure of heart disease and as a diet aid.
o Spirulina and glucomannan as diet aids.
o Ginseng as a panacea for many ailments.
o Alfalfa tablets for treatment of arthritis.
o Aloe vera for treatment of an array of unrelated medical conditions.
o Para-aminobenzoic acid (PABA) as an essential or curative nutrient.
o Pangamic acid, the so-called vitamin B,,, as an essential nutrient.
o Hair analysis for determination of nutritional status.
o Oral chelation products as treatment for heart disease.

The public incurs other costs because many products labeled as "natural"
or "organic" sell for higher prices than their "regular" counterparts, al-
though their special benefits are not generally demonstrable (Gourdine,
Traiger, and Cohen 1983). "Natural" vitamins, for example, often sell at
twice the price of synthetic products even though they are chemically
identical. In some such products labeled as "natural," only a minor fraction
of the vitamin is actually derived from natural sources (Seneker 1979; FDA
1979).

Although many food supplements are of unproven benefit, the food supple-
ment industry has expanded rapidly over the past several years (Stewart et
al. 1985). Consumer spending for the entire nutritional supplement mar-
ket-which includes nonprescription vitamins, minerals, and other prod-
ucts-was estimated to approach $2.7 billion for 1983, an increase of 5.3
percent over the 1982 sales volume (Ehrlich 1985).

Impact on Responsible Industry

Nutrition fraud can also have an adverse economic impact on responsible
members of the food industry. The false claims made by food faddists and
promoters of fraudulent products cause confusion in the minds of consum-
ers and may result in a distrust of the regular food supply and its products-
a distrust that may paradoxically increase the frequency and severity of
poor nutritional practices and food quackery. Although regulatory agencies
are responsible for maintaining a fair marketing environment, the cost of
combatting fraudulent activities often exceeds the available regulatory
resources.

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Summary

In summary, nutrition fraud in its various forms is prevalent in this country.
Health professionals and other authorities consider it to be a significant
public health problem, as well as one that can affect economic well-being.
Furthermore, the use of sophisticated communication marketing tech-
niques has substantially increased public exposure to nutrition fraud.

Implications for Public Health Policy

Dietary Guidance

General Public

Running counter to-and sometimes capitalizing on-legitimate gains in
scientific understanding of the relationships between diet and health, food
faddism and nutrition fraud are increasingly prevalent in the United States.
Although most of the adverse consequences of this trend are economic,
fraud can cause significant health consequences to individuals as a result of
direct toxicity and as a result of failure to seek appropriate medical care or
to engage in genuinely healthful dietary practices. Cooperative educational
efforts by Government, health professionals, and the private sector, includ-
ing the news media, are needed to expose emerging fads and frauds before
they are widely accepted. One approach to this end is general public
education to reinforce the basic principles of sound nutrition as stated in
the Dietary Guidelines for Americans. Another approach is to direct the
public to responsible sources of nutrition information.

Special Populations

Special efforts should be directed toward older persons, who are the target
of much nutrition fraud. Cooperative educational efforts by Government
and the private sector, such as current collaborations of the FDA with the
Pharmaceutical Advertising Council and the Council of Better Business
Bureaus, can provide effective support for Government enforcement pro-
grams. People with chronic debilitating illnesses-such as cancer, coro-
nary heart disease, arthritis, or Alzheimer's disease-may be especially
susceptible to fads and frauds, and health providers should be informed
about the most common schemes in each area and should be involved in the
effort to forewarn patients.

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O Nutrition and Health

Nutrition Programs and Services

Food Labels

Food labels should contain information about nutrient content that is
provided in a straightforward, effective, and effkient way. Should a health-
claims-approved program be implemented, claims for a particular product
should be presented in a manner that is most informative, scientifically
sound, and not misleading to consumers.

Food Services

Education provided in the context of food services should emphasize
general principles of sound nutrition for the general public and inform
people about the nature of and problems associated with common nutri-
tional frauds and fads.

Food Products

The FDA is charged with ensuring that misleading claims about foods are
not presented to the public and that specific foods are not promoted as
therapeutic or preventive agents unless there is adequate documentation to
support such claims. Continued support for, and vigilence by, the FDA is
important in this regard. A cornerstone of this effort is close coordination
of regulation and enforcement activities of the various agencies at the
Federal, State, and local levels through coalitions developed against nutri-
tion fraud.

Research and Surveillance

Research and surveillance issues of special priority related to the issue of
food fads and frauds should include investigations into:
o Frequency and type of fraudulent claims and harmful effects.
o Establishment of safe levels of essential nutrients as well as other
  components in food.

o The personal and behavioral factors that enhance response to certain
unscientific claims and ways to counter them.
o The level of use of vitamin, mineral, and food components that may
induce nutrient toxicities or deficiencies by the general public.

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