Many of my personal training clients come to me asking which supplements (liquids, pills, powders, etc.) are the best. In the past, I would have suggested a few 'dietary supplements' that I have used. After listening to my body, working on several research papers, accessing several databases, and finding alarming results, my answer is that "I WILL NOT SUGGEST ANY SUPPLEMENTS". They are not regulated any different than cosmetics! If you lack energy, find your energy source through real foods. We need a combination of carbohydrates, proteins, and fats. These foods should hold their form, such as a vegetable or fruit from the earth, or a cut of meat that has been cooked with zero to little 'preservatives'. Use spices and herbs to change the flavor. Whatever happened to 'eat to live', not 'live to eat'? Sure, I eat out up to four times each month. That's four meals! It's the behavior that makes the difference. If you want to change the way you feel, whether it be about your body or your body's level of energy, you must change the way you think and the way you move your body.
Journalism is what many people depend on for their information. Whether it be through newspapers, magazines, television, or the internet, keep in mind that you are only viewing or hearing the opinions and statements the journalists want you to understand. Take a look at the information below. I have found the following information from the FDA's website. This is copied, pasted, and YES, I have highlighted, in RED, areas that might catch the attention of those who do not want to spend the time to read. Keep in mind that the FDA can only inspect so many supplements, due to funding.
If you're still interested in reading more information, check out Consumer Reports September 2010 article "Dangerous supplements", pages 16-20.
Put your health first. Do your own research to make sure the "INSTANT GRATIFICATION" from your chosen supplement is not linked to what could be your future medical bills.
In Health and Happiness,
~ Eve
Q&A on Dietary Supplements
NOTE: For information concerning
DMAA (also known as 1,3-dimethylamylamine, methylhexanamine or geranium
extract), see Q
& A on DMAA in Dietary Supplements.
- What is a dietary supplement?
- What is a "new dietary ingredient" in a dietary supplement?
- Should I check with my doctor or healthcare provider before using a supplement?
- What is FDA's role in regulating dietary supplements versus the manufacturer's responsibility for marketing them?
- When must a manufacturer or distributor notify FDA about a dietary supplement it intends to market in the U.S.?
- What information must the manufacturer disclose on the label of a dietary supplement?
- Must all ingredients be declared on the label of a dietary supplement?
- Are dietary supplement serving sizes standardized or are there restrictions on the amount of a nutrient that can be in one serving?
- Where can I get information about a specific dietary supplement?
- What are some tips on searching the Web for information on dietary supplements?
- Who has the responsibility for ensuring that a dietary supplement is safe?
- Do manufacturers or distributors of dietary supplements have to tell FDA or consumers what evidence they have about their product's safety or what evidence they have to back up the claims they are making for them?
- How can consumers inform themselves about safety and other issues related to dietary supplements?
- What is FDA's oversight responsibility for dietary supplements?
- Does FDA routinely analyze the content of dietary supplements?
- Is it legal to market a dietary supplement product as a treatment or cure for a specific disease or condition?
- Who validates claims and what kinds of claims can be made on dietary supplement labels?
- Why do some supplements have wording (a disclaimer) that says: "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease"?
- How are advertisements for dietary supplements regulated?
- How do I, my health care provider, or any informed individual report a problem or illness caused by a dietary supplement to FDA?
Congress defined the term
"dietary supplement" in the Dietary Supplement Health and Education
Act (DSHEA) of 1994. A dietary supplement is a product taken by mouth that
contains a "dietary ingredient" intended to supplement the diet. The
"dietary ingredients" in these products may include: vitamins,
minerals, herbs or other botanicals, amino acids, and substances such as
enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can
also be extracts or concentrates, and may be found in many forms such as
tablets, capsules, softgels, gelcaps, liquids, or powders. They can also be in
other forms, such as a bar, but if they are, information on their label must
not represent the product as a conventional food or a sole item of a meal or
diet. Whatever their form may be, DSHEA places dietary supplements in a special
category under the general umbrella of "foods," not drugs, and
requires that every supplement be labeled a dietary supplement.
The Dietary Supplement Health and
Education Act (DSHEA) of 1994 defined both of the terms "dietary ingredient"
and "new dietary ingredient" as components of dietary supplements. In
order for an ingredient of a dietary supplement to be a "dietary
ingredient," it must be one or any combination of the following
substances:
- a vitamin,
- a mineral,
- an herb or other botanical,
- an amino acid,
- a dietary substance for use by man to supplement the diet by increasing the total dietary intake (e.g., enzymes or tissues from organs or glands), or
- a concentrate, metabolite, constituent or extract.
A "new dietary ingredient"
is one that meets the above definition for a "dietary ingredient" and
was not sold in the U.S. in a dietary supplement before October 15, 1994.
In October 1994, the Dietary
Supplement Health and Education Act (DSHEA) was signed into law by President
Clinton. Before this time, dietary supplements were subject to the same
regulatory requirements as were other foods. This new law, which amended the Federal Food, Drug, and Cosmetic Act,
created a new regulatory framework for the safety and labeling of dietary
supplements.Under DSHEA, a firm is responsible for determining that the dietary
supplements it manufactures or distributes are safe and that any
representations or claims made about them are substantiated by adequate
evidence to show that they are not false or misleading. This
means that dietary supplements do not need approval from FDA before they are
marketed. Except in the case
of a new dietary ingredient, where pre-market review for safety data and other
information is required by law, a firm does not
have to provide FDA with the evidence it relies on to substantiate safety or
effectiveness before or after it markets its products.Also,
manufacturers need to register themselves pursuant to the Bioterrorism
Act with FDA before producing or selling supplements. In June, 2007, FDA
published comprehensive regulations for Current Good Manufacturing Practices
for those who manufacture, package or hold dietary supplement
products. These regulations focus on practices that ensure the identity,
purity, quality, strength and composition of dietary supplements.
The Dietary Supplement Health and
Education Act (DSHEA) requires that a manufacturer or distributor notify FDA if
it intends to market a dietary supplement in the U.S. that contains a "new
dietary ingredient." The manufacturer (and distributor) must demonstrate
to FDA why the ingredient is reasonably expected to be safe for use in a
dietary supplement, unless it has been recognized as a food substance and is
present in the food supply.There is no authoritative list of dietary
ingredients that were marketed before October 15, 1994. Therefore,
manufacturers and distributors are responsible for determining if a dietary
ingredient is "new", and if it is not, for documenting that the
dietary supplements its sells, containing the dietary ingredient, were marketed
before October 15, 1994. For more detailed information, see new
dietary ingredients.
FDA regulations require that certain
information appear on dietary supplement labels. Information that must be on a
dietary supplement label includes: a descriptive name of the product stating
that it is a "supplement;" the name and place of business of the
manufacturer, packer, or distributor; a complete list of ingredients; and the
net contents of the product.In addition, each dietary supplement (except for
some small volume products or those produced by eligible small businesses) must
have nutrition labeling in the form of a"Supplement Facts" panel.
This label must identify each dietary ingredient contained in the product.
Yes, ingredients not listed on the
"Supplement Facts" panel must be listed in the "other
ingredient" statement beneath the panel. The types of ingredients listed
there could include the source of dietary ingredients, if not identified in the
"Supplement Facts" panel (e.g., rose hips as the source of vitamin C),
other food ingredients (e.g., water and sugar), and technical additives or
processing aids (e.g., gelatin, starch, colors, stabilizers, preservatives, and
flavors). For more details, see: Federal Register Final Rule - 62 FR 49826
September 23, 1997.
Other than the manufacturer's
responsibility to ensure safety, there are no rules that limit a serving size
or the amount of a nutrient in any form of dietary supplements. This decision
is made by the manufacturer and does not require FDA review or approval.
Manufacturers and
distributors do not need FDA approval to sell their dietary supplements. This means
that FDA does not keep a list of manufacturers, distributors or the dietary
supplement products they sell. If you want more detailed information than the
label tells you about a specific product, you may contact the manufacturer of
that brand directly. The name and address of the manufacturer or distributor
can be found on the label of the dietary supplement.
By law (DSHEA), the
manufacturer is responsible for ensuring that its dietary supplement products
are safe before they are marketed. Unlike drug products that must be
proven safe and effective for their intended use before marketing, there are no provisions in the law for FDA to
"approve" dietary supplements for safety or effectiveness before they
reach the consumer. Under
DSHEA, once the product 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 or removal from the marketplace. However,
manufacturers and distributors of dietary supplements must record, investigate
and forward to FDA any reports they receive of serious adverse events
associated with the use of their products that are reported to them directly.
FDA is able to evaluate these reports and any other adverse event information
reported directly to us by healthcare providers or consumers to identify early
signals that a product may present safety risks to consumers. You can find more
information on reporting adverse events associated with the use of dietary
supplements at Dietary
Supplements - Adverse Event Reporting.
No, except for rules described above
that govern "new dietary ingredients," there
is no provision under any law or regulation that FDA enforces that requires a
firm to disclose to FDA or consumers the information they have about the safety
or purported benefits of their dietary supplement products. Likewise,
there is no prohibition against them making this information available either
to FDA or to their customers. It is up to each firm to set its own policy on
disclosure of such information. For more information, see claims
that can be made for dietary supplements
It is important to be well
informed about products before purchasing them. Because it
is often difficult to know what information is reliable and what is
questionable, consumers may first want to contact the manufacturer about the
product they intend to purchase (see previous question "Where can I get
information about a specific dietary supplement?"). In addition, to help
consumers in their search to be better informed, FDA is providing the following
sites: Tips
For The Savvy Supplement User: Making Informed Decisions And Evaluating
Information (includes information on how to evaluate research findings and
health information on-line) and Claims
That Can Be Made for Conventional Foods and Dietary Supplements, (provides
information on what types of claims can be made for dietary supplements).
Because dietary supplements are
under the "umbrella" of foods, FDA's Center for Food Safety and Applied
Nutrition (CFSAN) is responsible for the agency's oversight of these products.
FDA's efforts to monitor the marketplace for potential illegal products
(that is, products that may be unsafe or make false or misleading claims)
include obtaining information from inspections of dietary supplement
manufacturers and distributors, the Internet, consumer and trade complaints,
occasional laboratory analyses of selected products, and adverse events
associated with the use of supplements that are reported to the agency.
In that FDA has limited resources to
analyze the composition of food products, including dietary supplements, it
focuses these resources first on public health emergencies and products that
may have caused injury or illness. Enforcement priorities then go to products
thought to be unsafe or fraudulent or in violation of the law. The remaining
funds are used for routine monitoring of products pulled from store shelves or
collected during inspections of manufacturing firms. The agency does not
analyze dietary supplements before they are sold to consumers. The manufacturer
is responsible for ensuring that the "Supplement Facts" label and
ingredient list are accurate, that the dietary ingredients are safe, and that
the content matches the amount declared on the label. FDA
does not have resources to analyze dietary supplements sent to the agency by
consumers who want to know their content. Instead, consumers may contact the
manufacturer or a commercial laboratory for an analysis of the content.
No, a product sold as a dietary
supplement and promoted on its label or in labeling* as a treatment, prevention
or cure for a specific disease or condition would be considered an
unapproved--and thus illegal--drug. To maintain the product's status as a
dietary supplement, the label and labeling must be consistent with the
provisions in the Dietary Supplement Health and Education Act (DSHEA) of
1994.*Labeling refers to the label as well as accompanying material that is
used by a manufacturer to promote and market a specific product.
FDA receives many consumer inquiries
about the validity of claims for dietary supplements, including product labels,
advertisements, media, and printed materials. The responsibility for ensuring
the validity of these claims rests with the manufacturer, FDA, and, in the case
of advertising, with the Federal Trade Commission.By law, manufacturers may
make three types of claims for their dietary supplement products: health
claims, structure/function claims, and nutrient content claims. Some of these
claims describe: the link between a food substance and disease or a
health-related condition; the intended benefits of using the product; or the
amount of a nutrient or dietary substance in a product. Different requirements
generally apply to each type of claim, and are described
in more detail.
This statement or
"disclaimer" is required by law (DSHEA) when a manufacturer makes a
structure/function claim on a dietary supplement label. In general, these
claims describe the role of a nutrient or dietary ingredient intended to affect
the structure or function of the body. The manufacturer is responsible for
ensuring the accuracy and truthfulness of these claims; they are not approved
by FDA. For this reason, the law says that if a dietary supplement label
includes such a claim, it must state in a "disclaimer" that FDA has
not evaluated this claim. The disclaimer must also state that this product is
not intended to "diagnose, treat, cure or prevent any disease,"
because only a drug can legally make such a claim.
The Federal Trade Commission (FTC)
regulates advertising, including infomercials, for dietary supplements and most
other products sold to consumers. FDA works closely with FTC in this area, but
FTC's work is directed by different laws. For more information on FTC, go to
the FTC web site 
. Advertising and promotional material received in the mail
are also regulated under different laws and are subject to regulation by the
U.S. Postal Inspection Service.
. Advertising and promotional material received in the mail
are also regulated under different laws and are subject to regulation by the
U.S. Postal Inspection Service.
If you think you have suffered a
serious harmful effect or illness from a dietary supplement, the first thing
you should do is contact or see your healthcare provider immediately. Then, you
or your health care provider can report this by submitting a report through the
Safety Reporting Portal. If you do not have access to the
internet, you may submit a report by calling FDA's MedWatch hotline at
1-800-FDA-1088.
FDA would like to know
when a dietary supplement causes a problem even if you are unsure the product
caused the problem or even if you do not visit a doctor or clinic. Anyone may
report a serious adverse event or illness thought to be related to a dietary
supplement directly to FDA by accessing the SRP mentioned above.
Consumers are also encouraged to
report instances of product problems using the Safety Reporting Portal . Examples of product problems are
foreign objects in the packaging or other apparent quality defects.
In addition to communicating with
FDA on-line or by phone, you may use the postage-paid MedWatch form available
from the FDA Web site.
NOTE: The identity of the reporter
and/or patient is kept confidential. For a general complaint or concern about
food products, including dietary supplements, you may contact the consumer
complaint coordinator at the local FDA District Office nearest you. See the
following Web address for the telephone number: Consumer Complaint
Coordinators15.
Reference:
