An FDA Guide to Dietary Supplements

An FDA Guide to Dietary
Supplements

by Paula Kurtzweil
U. S. Food and Drug
Administration
FDA Consumer
September – October 1998; Revised January 1999

Set between a Chinese restaurant and a
pizza and sub sandwich eatery, a Rockville health food store offers yet
another brand of edible items: Bottled herbs like cat’s claw, dandelion
root, and blessed thistle. Vitamins and minerals in varying doses.
Herbal and nutrient concoctions whose labels carry claims about
relieving pain, “energizing” and “detoxifying” the
body, or providing “guaranteed results.”

This store sells dietary supplements,
some of the hottest selling items on the market today. Surveys show that
more than half of the U.S. adult population uses these products. In 1996
alone, consumers spent more than $6.5 billion on dietary supplements,
according to Packaged Facts Inc., a market research firm in New York
City.

But even with all the business they
generate, consumers still ask questions about dietary supplements: Can
their claims be trusted? Are they safe? Does the Food and Drug
Administration approve them?

Many of these questions come in the
wake of the 1994 Dietary Supplement Health and Education Act, or DSHEA,
which set up a new framework for FDA regulation of dietary supplements.
It also created an office in the National Institutes of Health to
coordinate research on dietary supplements, and it called on President
Clinton to set up an independent dietary supplement commission to report
on the use of claims in dietary supplement labeling.

In passing DSHEA, Congress recognized
first, that many people believe dietary supplements offer health
benefits and second, that consumers want a greater opportunity to
determine whether supplements may help them. The law essentially gives
dietary supplement manufacturers freedom to market more products as
dietary supplements and provide information about their products’
benefits–for example, in product labeling.

The Council for Responsible Nutrition,
an organization of manufacturers of dietary supplements and their
suppliers, welcomes the change. “Our philosophy has been … to
maintain consumer access to products and access to information �so that
consumers can| make informed choices,” says John Cordaro, the
group’s president and chief executive officer.

But in choosing whether to use dietary
supplements, FDA answers consumers’ questions by noting that under DSHEA,
FDA’s requirement for premarket review of dietary supplements is less
than that over other products it regulates, such as drugs and many
additives used in conventional foods.

This means that consumers and
manufacturers have responsibility for checking the safety of dietary
supplements and determining the truthfulness of label claims.

Anatomy of the New Requirements
for Dietary Supplement Labels

Information that will be required on
the labels of dietary supplements includes:

  • Statement of identity (e.g.,
    “ginseng”)
    Net quantity of contents (e.g.,
    “60 capsules”)
    Structure-function claim and the
    statement “This statement has not been evaluated by the Food
    and Drug Administration. This product is not intended to diagnose,
    treat, cure, or prevent any disease.”
    Directions for use (e.g., “Take
    one capsule daily.”)
    Supplement Facts panel (lists
    serving size, amount, and active ingredient)
    Other ingredients in descending
    order of predominance and by common name or proprietary blend.
    Name and place of business of
    manufacturer, packer or distributor. This is the address to write
    for more product information.

What Is a Dietary Supplement?

Traditionally, dietary supplements
referred to products made of one or more of the essential nutrients,
such as vitamins, minerals, and protein. But DSHEA broadens the
definition to include, with some exceptions, any product intended for
ingestion as a supplement to the diet. This includes vitamins; minerals;
herbs, botanicals, and other plant-derived substances; and amino acids
(the individual building blocks of protein) and concentrates,
metabolites, constituents and extracts of these substances.

It’s easy to spot a supplement because
DSHEA requires manufacturers to include the words “dietary
supplement” on product labels. Also, starting in March 1999, a
“Supplement Facts” panel will be required on the labels of
most dietary supplements.

Dietary supplements come in many forms,
including tablets, capsules, powders, softgels, gelcaps, and liquids.
Though commonly associated with health food stores, dietary supplements
also are sold in grocery, drug and national discount chain stores, as
well as through mail-order catalogs, TV programs, the Internet, and
direct sales.

FDA oversees safety, manufacturing and
product information, such as claims, in a product’s labeling, package
inserts, and accompanying literature. The Federal Trade Commission
regulates the advertising of dietary supplements.

One thing dietary supplements are not
is drugs. A drug, which sometimes can be derived from plants used as
traditional medicines, is an article that, among other things, is
intended to diagnose, cure, mitigate, treat, or prevent diseases. Before
marketing, drugs must undergo clinical studies to determine their
effectiveness, safety, possible interactions with other substances, and
appropriate dosages, and FDA must review these data and authorize the
drugs’ use before they are marketed. FDA does not authorize or test
dietary supplements.

A product sold as a dietary supplement
and touted in its labeling as a new treatment or cure for a specific
disease or condition would be considered an unauthorized–and thus
illegal–drug. Labeling changes consistent with the provisions in DSHEA
would be required to maintain the product’s status as a dietary
supplement.

Another thing dietary supplements are
not are replacements for conventional diets, nutritionists say.
Supplements do not provide all the known–and perhaps
unknown–nutritional benefits of conventional food.

Monitoring for Safety

As with food, federal law requires
manufacturers of dietary supplements to ensure that the products they
put on the market are safe. But supplement manufacturers do not have to
provide information to FDA to get a product on the market, unlike the
food additive process often required of new food ingredients. FDA review
and approval of supplement ingredients and products is not required
before marketing.

Food additives not generally recognized
as safe must undergo FDA’s premarket approval process for new food
ingredients. This requires manufacturers to conduct safety studies and
submit the results to FDA for review before the ingredient can be used
in marketed products. Based on its review, FDA either authorizes or
rejects the food additive.

In contrast, dietary supplement
manufacturers that wish to market a new ingredient (that is, an
ingredient not marketed in the United States before 1994) have two
options. The first involves submitting to FDA, at least 75 days before
the product is expected to go on the market, information that supports
their conclusion that a new ingredient can reasonably be expected to be
safe. Safe means that the new ingredient does not present a significant
or unreasonable risk of illness or injury under conditions of use
recommended in the product’s labeling.

The information the manufacturer
submits becomes publicly available 90 days after FDA receives it.

Another option for manufacturers is to
petition FDA, asking the agency to establish the conditions under which
the new dietary ingredient would reasonably be expected to be safe. To
date, FDA’s Center for Food Safety and Applied Nutrition has received no
such petitions.

Under DSHEA, once a dietary supplement
is marketed, FDA has the responsibility for showing that a dietary
supplement is unsafe before it can take action to restrict the product’s
use. This was the case when, in June 1997, FDA proposed, among other
things, to limit the amount of ephedrine alkaloids in dietary
supplements (marketed as ephedra, Ma huang, Chinese ephedra, and
epitonin, for example) and provide warnings to consumers about hazards
associated with use of dietary supplements containing the ingredients.
The hazards ranged from nervousness, dizziness, and changes in blood
pressure and heart rate to chest pain, heart attack, hepatitis, stroke,
seizures, psychosis, and death. The proposal stemmed from FDA’s review
of adverse event reports it had received, scientific literature, and
public comments. FDA has received many comments on the 1997 proposal and
was reviewing them at press time.

Also in 1997, FDA identified
contamination of the herbal ingredient plantain with the harmful herb
Digitalis lanata after receiving a report of a complete heart block in a
young woman. FDA traced all use of the contaminated ingredient and asked
manufacturers and retailers to withdraw these products from the market.
(For information about other potentially dangerous dietary supplements,
see “Supplements
Associated with Illnesses and Injuries.”
)

DSHEA also gives FDA authority to
establish good manufacturing practices, or GMPs, for dietary
supplements. In a February 1997 advance notice of proposed rulemaking,
the agency said it would establish dietary supplement GMPs if, after
public comment, it determined that GMPs for conventional food are not
adequate to cover dietary supplements, as well. GMPs, the agency said,
would ensure that dietary supplements are made under conditions that
would result in safe and properly labeled products. At press time, FDA
was reviewing comments on the 1997 notice.

Some supplement makers may already
voluntarily follow GMPs devised, for example, by trade groups.

Besides FDA, individual states can take
steps to restrict or stop the sale of potentially harmful dietary
supplements within their jurisdictions. For example, Florida has banned
some ephedra-containing products, and other states have said they are
considering similar action.

Also, the industry strives to regulate
itself, the Council for Responsible Nutrition’s Cordaro says. He cites
the GMPs that his trade group and others developed for their member
companies. FDA is reviewing these GMPs as it considers whether to pursue
mandatory industry-wide GMPs. Another example of self-regulation,
Cordaro says, is the voluntary use of a warning about ephedra products
that his organization drafted. He says that about 90 percent of U.S.
manufacturers of products containing ephedra alkaloids now use this
warning label.

Understanding Claims

Claims that tout a supplement’s
healthful benefits have always been a controversial feature of dietary
supplements. Manufacturers often rely on them to sell their products.
But consumers often wonder whether they can trust them.

Under DSHEA and previous food labeling
laws, supplement manufacturers are allowed to use, when appropriate,
three types of claims: nutrient-content claims, disease claims, and
nutrition support claims, which include “structure-function
claims.”

Nutrient-content claims describe the
level of a nutrient in a food or dietary supplement. For example, a
supplement containing at least 200 milligrams of calcium per serving
could carry the claim “high in calcium.” A supplement with at
least 12 mg per serving of vitamin C could state on its label,
“Excellent source of vitamin C.”

Disease claims show a link between a
food or substance and a disease or health-related condition. FDA
authorizes these claims based on a review of the scientific evidence.
Or, after the agency is notified, the claims may be based on an
authoritative statement from certain scientific bodies, such as the
National Academy of Sciences, that shows or describes a well-established
diet-to-health link. As of this writing, certain dietary supplements may
be eligible to carry disease claims, such as claims that show a link
between:

  • the vitamin folic acid and a
    decreased risk of neural tube defect-affected pregnancy, if the
    supplement contains sufficient amounts of folic acid
    calcium and a lower risk of
    osteoporosis, if the supplement contains sufficient amounts of
    calcium
    psyllium seed husk (as part of a
    diet low in cholesterol and saturated fat) and coronary heart
    disease, if the supplement contains sufficient amounts of psyllium
    seed husk.

Nutrition support claims can describe a
link between a nutrient and the deficiency disease that can result if
the nutrient is lacking in the diet. For example, the label of a vitamin
C supplement could state that vitamin C prevents scurvy. When these
types of claims are used, the label must mention the prevalence of the
nutrient-deficiency disease in the United States.
These claims also can refer to the
supplement’s effect on the body’s structure or function, including its
overall effect on a person’s well-being. These are known as
structure-function claims.
Examples of structure-function claims
are:

  • Calcium builds strong bones.
    Antioxidants maintain cell
    integrity.
    Fiber maintains bowel regularity.

Manufacturers can use structure-function
claims without FDA authorization. They base their claims on their review
and interpretation of the scientific literature. Like all label claims,
structure-function claims must be true and not misleading.
Structure-function claims can be easy
to spot because, on the label, they must be accompanied with the
disclaimer “This statement has not been evaluated by the Food and
Drug Administration. This product is not intended to diagnose, treat,
cure, or prevent any disease.”
Manufacturers who plan to use a
structure-function claim on a particular product must inform FDA of the
use of the claim no later than 30 days after the product is first
marketed. While the manufacturer must be able to substantiate its claim,
it does not have to share the substantiation with FDA or make it
publicly available.
If the submitted claims promote the
products as drugs instead of supplements, FDA can advise the
manufacturer to change or delete the claim.
Because there often is a fine line
between disease claims and structure-function claims, FDA in April 1998
proposed regulations that would establish criteria under which a label
claim would or would not qualify as a disease claim. Among label factors
FDA proposed for consideration are:

  • the naming of a specific disease or
    class of diseasesthe use of scientific or lay
    terminology to describe the product’s effect on one or more signs or
    symptoms recognized by health-care professionals and consumers as
    characteristic of a specific disease or a number of different
    specific diseasesproduct name statements about product formulation
    citations or references that refer
    to disease use of the words “disease”
    or “diseased” art, such as symbols and pictures statements that the product can
    substitute for an approved therapy (for example, a drug).

FDA’s proposal is consistent with the
guidance on the distinction between structure-function and disease
claims provided in the 1997 report by the President’s Commission on
Dietary Supplement Labels.If shoppers find dietary supplements
whose labels state or imply that the product can help diagnose, treat,
cure, or prevent a disease (for example, “cures cancer” or
“treats arthritis”), they should realize that the product is
being marketed illegally as a drug and as such has not been evaluated
for safety or effectiveness.FTC regulates claims made in the
advertising of dietary supplements, and in recent years, that agency has
taken a number of enforcement actions against companies whose
advertisements contained false and misleading information. The actions
targeted, for example, erroneous claims that chromium picolinate was a
treatment for weight loss and high blood cholesterol. An action in 1997
targeted ads for an ephedrine alkaloid supplement because they
understated the degree of the product’s risk and featured a man falsely
described as a doctor.Fraudulent Products
Consumers need to be on the lookout for
fraudulent products. These are products that don’t do what they say they
can or don’t contain what they say they contain. At the very least, they
waste consumers’ money, and they may cause physical harm.
Fraudulent products often can be
identified by the types of claims made in their labeling, advertising
and promotional literature. Some possible indicators of fraud, says
Stephen Barrett, M.D., a board member of the National Council Against
Health Fraud, are:

  • Claims that the product is a secret
    cure and use of such terms as “breakthrough,”
    “magical,” “miracle cure,” and “new
    discovery.” If the product were a cure for a serious disease,
    it would be widely reported in the media and used by health-care
    professionals, he says.
    “Pseudomedical” jargon,
    such as “detoxify,” “purify” and
    “energize” to describe a product’s effects. These claims
    are vague and hard to measure, Barrett says. So, they make it easier
    for success to be claimed “even though nothing has actually
    been accomplished,” he says.
    Claims that the product can cure a
    wide range of unrelated diseases. No product can do that, he says.
    Claims that a product is backed by
    scientific studies, but with no list of references or references
    that are inadequate. For instance, if a list of references is
    provided, the citations cannot be traced, or if they are traceable,
    the studies are out-of-date, irrelevant, or poorly designed.
    Claims that the supplement has only
    benefits–and no side effects. A product “potent enough to help
    people will be potent enough to cause side effects,” Barrett
    says.
    Accusations that the medical
    profession, drug companies and the government are suppressing
    information about a particular treatment. It would be illogical,
    Barrett says, for large numbers of people to withhold information
    about potential medical therapies when they or their families and
    friends might one day benefit from them.

Though often more difficult to do,
consumers also can protect themselves from economic fraud, a practice in
which the manufacturer substitutes part or all of a product with an
inferior, cheaper ingredient and then passes off the fake product as the
real thing but at a lower cost. Varro Tyler, Ph.D., Sc.D., a
distinguished professor emeritus of pharmacognosy (the study of
medicinal products in their crude, or unprepared, form) at Purdue
University in West LaFayette, Ind., advises consumers to avoid products
sold for considerably less money than competing brands. “If it’s
too cheap, the product is probably not what it’s supposed to be,”
he says.
Quality Products Poor manufacturing practices are not
unique to dietary supplements, but the growing market for supplements in
a less restrictive regulatory environment creates the potential for
supplements to be prone to quality-control problems. For example, FDA
has identified several problems where some manufacturers were buying
herbs, plants and other ingredients without first adequately testing
them to determine whether the product they ordered was actually what
they received or whether the ingredients were free from contaminants.
To help protect themselves, consumers
should:

  • Look for ingredients in products
    with the U.S.P. notation, which indicates the manufacturer followed
    standards established by the U.S. Pharmacopoeia.
    Realize that the label term
    “natural” doesn’t guarantee that a product is safe.
    “Think of poisonous mushrooms,” says Elizabeth Yetley,
    Ph.D., director of FDA’s Office of Special Nutritionals.
    “They’re natural.” Consider the name of the
    manufacturer or distributor. Supplements made by a nationally known
    food and drug manufacturer, for example, have likely been made under
    tight controls because these companies already have in place
    manufacturing standards for their other products.
    Write to the supplement manufacturer
    for more information. Ask the company about the conditions under
    which its products were made.

Reading and Reporting Consumers who use dietary supplements
should always read product labels, follow directions, and heed all
warnings. Supplement users who suffer a serious
harmful effect or illness that they think is related to supplement use
should call a doctor or other health-care provider. He or she in turn
can report it to FDA MedWatch by calling 1-800-FDA-1088 or going to
www.fda.gov/medwatch/report/hcp.htm on the MedWatch Website. Patients’
names are kept confidential. Consumers also may call the toll-free
MedWatch number or go to www.fda.gov/medwatch/report/consumer/consumer.htm
on the MedWatch Website to report an adverse reaction. To file a report,
consumers will be asked to provide:

  • name, address and telephone number
    of the person who became ill name and address of the doctor or
    hospital providing medical treatment description of the problem name of the product and store where
    it was bought.

Consumers also should report the problem
to the manufacturer or distributor listed on the product’s label and to
the store where the product was bought. >Today’s Dietary Supplements The report of the President’s
Commission on Dietary Supplement Labels, released in November 1997,
provides a look at the future of dietary supplements. It encourages
researchers to find out whether consumers want and can use the
information allowed in dietary supplement labeling under DSHEA. It
encourages studies to identify more clearly the relationships between
dietary supplements and health maintenance and disease prevention. It
urges FDA to take enforcement action when questions about a product’s
safety arise. And it suggests that FDA and the industry work together to
develop guidelines on the use of warning statements on dietary
supplement labels. FDA generally concurred with the
commission’s recommendations in the agency’s 1998 proposed rule on
dietary supplement claims. While much remains unknown about many
dietary supplements–their health benefits and potential risks, for
example–there’s one thing consumers can count on: the availability of a
wide range of such products. But consumers who decide to take advantage
of the expanding market should do so with care, making sure they have
the necessary information and consulting with their doctors and other
health professionals as needed. “The majority of supplement
manufacturers are responsible and careful,” FDA’s Yetley says.
“But, as with all products on the market, consumers need to be
discriminating. FDA and industry have important roles to play, but
consumers must take responsibility, too.” Paula Kurtzweil is a member of
FDA’s public affairs staff.