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Nutrition, Vitamins & Supplements for Seniors
FDA Rules on Dietary Supplement Manufacturers Good
News for Boomers, Senior Citizens
What you need to know about supplements. Government
already provides lots of helpful information
| |
More about what you
need to know about dietary supplements - See below news report:
> Consumer article
by FDA
>Link to special FDA
guide for senior citizens
> Links to info at
USDA and National Institutes of Health
> What are dietary
supplements? |
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July 5, 2007 - The Food and Drug Administration
made a significant move on June 22 to establish regulations to require
the manufacturers of dietary supplements to adhere to practices that
will ensure the products are produced in a quality manner, do not
contain contaminants or impurities, and are accurately labeled. It
should be welcomed news to senior citizens and baby boomers – in
particular women, who are the leading consumers of these products
designed to enhance health.
The major goal is to be sure the products contain
what the label says they do.
"This rule helps to ensure the quality of dietary
supplements so that consumers can be confident that the products they
purchase contain what is on the label," said Commissioner of Food and
Drugs Andrew C. von Eschenbach, M.D.
"In addition, as a result of recent amendments to
the Federal Food, Drug, and Cosmetic Act, by the end of the year,
industry will be required to report all serious dietary supplement
related adverse events to FDA."
The final rule includes requirements for
establishing quality control procedures, designing and constructing
manufacturing plants, and testing ingredients and the finished product.
It also includes requirements for recordkeeping and handling consumer
product complaints.
Under the final rule, manufacturers are required to
evaluate the identity, purity, strength, and composition of their
dietary supplements. If dietary supplements contain contaminants or do
not contain the dietary ingredient they are represented to contain, FDA
would consider those products to be adulterated or misbranded.
The aim of the final rule is to prevent inclusion
of the wrong ingredients, too much or too little of a dietary
ingredient, contamination by substances such as natural toxins,
bacteria, pesticides, glass, lead and other heavy metals, as well as
improper packaging and labeling.
The final rule includes flexible requirements that
can evolve with improvements in scientific methods used for verifying
identity, purity strength, and composition of dietary supplements.
Under the interim final rule the manufacturer may
be exempted from the dietary ingredient identity testing requirement if
it can provide sufficient documentation that the reduced frequency of
testing requested would still ensure the identity of the dietary
ingredient. FDA is soliciting comment from the public on the interim
final rule. There will be a 90-day comment period, ending on September
24, 2007. Comments may be addressed to the Division of Dockets
Management Branch at
www.fda.gov/dockets/ecomments.
The final CGMP and the interim final rule are
effective August 24, 2007.
To limit any disruption for dietary supplements
produced by small businesses, the rule has a three-year phase-in for
small businesses. Companies with more than 500 employees have until June
2008 to comply, companies with less than 500 employees have until June
2009 to comply, and companies with fewer than 20 employees have until
June 2010 to comply with the regulations.
Backgrounder:
http://www.cfsan.fda.gov/~dms/dscgmps7.html
Fact Sheet:
http://www.cfsan.fda.gov/~dms/dscgmps6.html
To see a consumer article called "Final Rule
Promotes Safe Use of Dietary Supplements," visit
http://www.fda.gov/consumer/updates/dietarysupps062207.html.
Final Rule Promotes Safe Use of Dietary Supplements
Consumer article by FDA
|
 There
may be negative interactions associated with some dietary
supplements and other medicines you are taking. Consult a health
care provider before using any dietary supplement. |
Some dietary supplements are beneficial when taken
appropriately. Calcium supplements may strengthen bones and folic acid
lowers the risk of certain birth defects. But some supplements pose
health risks. They may contain harmful ingredients or be improperly
manufactured or handled.
On June 22, 2007, FDA announced a final rule
establishing current good manufacturing practice requirements (CGMPs)
for dietary supplements. In addition, by the end of the year, industry
will be required to report all serious dietary supplement adverse events
to FDA.
Ensuring Quality
Under the final rule, manufacturers are required to
evaluate the identity, purity, quality, strength, and composition of
dietary supplements.
"The dietary supplement CGMPs should increase
consumers' confidence in the quality of the dietary supplement products
that they purchase," says Robert E. Brackett, PhD, Director of FDA's
Center for Food Safety and Applied Nutrition. "These regulations provide
more accountability in the manufacturing process so that consumers can
be confident that the products they purchase contain what is on the
label."
The final rule aims to ensure that dietary
supplements do NOT have:
● wrong ingredients
● too much or too little of a dietary ingredient
● improper packaging
● improper labeling
● contamination problems due to natural toxins, bacteria, pesticides,
glass, lead, or other substances
How FDA Regulates Supplements
The final rule on CGMPs is a critical component of
the Dietary Supplement Health and Education Act of 1994 (DSHEA).
Under DSHEA, dietary supplements are regulated like
foods. Unlike new drugs, dietary supplements don't have to go through
review by FDA for safety and effectiveness or be "approved" before they
can be marketed. But manufacturers must provide premarket notice and
evidence of safety for any supplements they plan to sell that contain
dietary ingredients that were not marketed as dietary supplements before
DSHEA was passed—except that the premarket notice is not needed if the
new dietary ingredient had previously been used as in ingredient in
food.
Manufacturers are responsible for substantiating
the safety of dietary ingredients and also for determining that certain
structure/function and other claims they make about their products are
substantiated by adequate evidence to show that the claims are truthful
and not misleading.
FDA evaluates the safety of dietary supplements
after they are on the market through research and adverse event
monitoring. The agency is responsible for taking action against any
unsafe dietary supplement product after it reaches the market.
The final rule on CGMPs gives industry clear
expectations for manufacturing, packaging, labeling, and holding dietary
supplements. If dietary supplements are found to be contaminated or
lacking the appropriate ingredients, FDA will consider those products in
violation of the law and will evaluate its enforcement options.
Advice for Consumers
● Talk with a health care provider before using a
dietary supplement. This is a good idea, especially for certain
population groups. If you are pregnant, nursing a baby, or have a
chronic medical condition such as diabetes or heart disease, be sure to
consult your doctor or pharmacist before purchasing or taking any
supplement.
● Know that some supplements may interact with
prescription and over-the-counter medicines. Taking a combination of
supplements or using these products together with medications (whether
prescription or OTC drugs) could produce adverse effects, some of which
could be life-threatening. For example, Coumadin (a prescription
medicine), ginkgo biloba (an herbal supplement), aspirin (an OTC drug),
and vitamin E (a vitamin supplement) can each thin the blood, and taking
any of these products together can increase the potential for internal
bleeding.
● Inform your doctor about all the supplements
you use, especially before surgery. Some supplements can have unwanted
effects during surgery. You may be asked to stop taking these products
at least 2-3 weeks ahead of the procedure to avoid potentially dangerous
interactions. These interactions could cause changes in heart rate or
blood pressure, increased bleeding, or other problems that could
adversely affect the outcome of your surgery.
● Report adverse effects from the use of dietary
supplements to MedWatch. If you think you have been harmed by a dietary
supplement, contact your health provider and report it to FDA's MedWatch
program by calling (800) FDA-1088, or visiting
www.fda.gov/medwatch/how.htm
For more information about the safe use of dietary
supplements, visit
www.cfsan.fda.gov/~dms/ds-info.html
The
final rule on CGMPs for dietary supplements is available on the FDA
Web site.
●
About Dietary Supplements at the USDA
●
Vitamins and Mineral Supplements at National Institute of Health
What are Dietary Supplements?
 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.
What is a "new dietary ingredient" in 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.
Today's dietary supplements are not only vitamins
and minerals. They also include other less-familiar substances, such as
herbals, botanicals, amino acids, enzymes, and animal extracts. Some
dietary supplements are well understood and established, but others need
further study. Whatever your choice, supplements should not replace the
variety of foods important to a healthful diet.
Unlike drugs, dietary supplements are not
pre-approved by the government for safety or effectiveness before
marketing. Also, unlike drugs, supplements are not intended to treat,
diagnose, prevent, or cure diseases. But some supplements can help
assure that you get an adequate dietary intake of essential nutrients;
others may help you reduce your risk of disease.
Some older people, for example, are tired due to
low iron levels. In that case, their doctor may recommend an iron
supplement.
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