FDA Office On Dietary Supplements:
Proposal for Dietary Supplements Good Manufacturing Practices:
FDA’s Ephedra webpage:
Office of Dietary Supplements:
National Center for Complementary and
Bibliographies of Significant Advances in Dietary Supplement
NIH, Office of Dietary Supplements.
Supplement Fact Sheets,
supplement background information
Manufacturing Practice in Manufacturing, Packing, or Holding
Dietary Ingredients and Dietary Supplements; Proposed Rule:
68 FR 12158 (March 13, 2003)
Guidance for Industry: Statement of Identity, Nutrition Labeling,
and Ingredient Labeling of Dietary Supplements Small Entity
Draft guidance for industry: substantiation for dietary supplement claims
Register 64962-64964 (November 9, 2004)
The Food and Drug Administration (FDA) is announcing the availability of a
draft guidance entitled ``Guidance for Industry: Substantiation for Dietary
Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug,
and Cosmetic Act.'' This draft guidance describes the amount, type, and
quality of evidence that FDA recommends a manufacturer have to substantiate
a claim under section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act
(act). FDA is also announcing its decision not to publish additional
guidance on applying the structure/function rule at this time.
Dietary supplements; strategy for the further implementation and enforcement
of the Dietary Supplement Health and Education Act of 1994
Register 64957-64958 (November 9, 2004)
The Food and Drug Administration (FDA) is announcing the availability of its
strategy for the further implementation of the Dietary Supplement Health and
Education Act of 1994 (DSHEA). The strategy sets forth a series of specific,
integrated research and regulatory measures, including guidance,
regulations, and science-based compliance and enforcement mechanisms.
Through implementation of these measures, FDA hopes to improve the
transparency, predictability, and consistency both of the agency's
scientific evaluations of dietary supplement product and ingredient safety,
and of its regulatory actions to protect consumers against unsafe dietary
supplements and dietary supplements making unauthorized, false, or
FDA announces major initiatives for dietary supplements
Release P04-101 (November 4, 2004)
The Food and Drug Administration (FDA) announced three major regulatory
initiatives designed to further implement the Dietary Supplement Health and
Education Act of 1994 (DSHEA). These initiatives are: a regulatory strategy,
an open public meeting, and a draft guidance document for industry.
Dietary Supplements: An Advertising Guide for Industry clearly
and concisely explains FTC's approach to regulating advertising and
how to properly make claims on dietary supplement ads. The guide is
must reading for anyone considering advertising a dietary supplement
and is available at:
FDA Meets about Dietary Supplements
Morning Edition, November 15, 2004· The Food and Drug Administration holds a
public meeting about the safety of dietary supplements. Some of the products
have been blamed for harmful side effects, but Congress took away most of
the FDA's power over them 10 years ago. Now the FDA will meet to decide what
to do within the limits of that law. Listen at:
“Dirty Dozen” Dietary Supplements
Reports Issues List of Potentially Dangerous Supplements (April 1,
2004). Despite known hazards, many potentially dangerous dietary
supplements are readily available for purchase in stores and on the
Internet, according to a new report from Consumer Reports. Today,
the magazine released its "dirty dozen" list of dietary supplements
that it says are too dangerous to be on the market.
Dietary Supplements: A Framework
for Evaluating Safety,
Institute of Medicine, calls for companies to disclose adverse
effects in order to protect consumers. The OIG estimated that FDA
receives reports of less than 1 percent of all adverse reactions.
The report also outlines a science-based process for assessing
supplement ingredients. The report may be read or purchased at:
Fact Sheet on
FDA's Strategy for Dietary Supplements
Adverse Event Reporting For
Dietary Supplements An Inadequate Safety Valve, Department of
Health and Human Services, Office of Inspector General,
OEI-01-00-00180 (April 2001).
Health Effects of Androstenedione, FDA White Paper
(March 11, 2004)
Institute of Medicine
Report Urges More Reporting for Dietary Supplements
Institute of Medicine calls for companies to disclose
adverse effects in order to protect consumers. The OIG estimated
that FDA receives reports of less than 1 percent of all adverse
reactions. The report also outlines a science-based process for
assessing supplement ingredients. The report,
Supplements: A Framework for Evaluating Safety,
may be read or purchased at:
The Alternate Fix
Frontline (November 6, 2003)
examines the controversy over complementary and alternative
High-Dosage Vitamin E Supplementation May Increase All-Cause Mortality
Edgar R. Miller III, et al., Volume 142 Issue 1, Annals of Internal Medicine
(January 4, 2005). High-dosage (400 IU/day) vitamin E supplements may
increase all-cause mortality and should be avoided.
Vitamin E Supplements: Good in Theory, but Is the Theory Good?
Greenberg, MD, Annals of Internal Medicine, 142:000-000 (2005).
”Much of the U.S. public has a deep, and seemingly unshakable, faith in the
health benefits of nutritional supplements. . . .high-dose vitamin E
supplementation is unjustified. Ample evidence indicates that taking
high-dose vitamin E in later adult life (when most use of vitamins currently
occurs) has no favorable health effects, and Miller and colleagues'
meta-analysis raises the possibility of harm. Thus, our message to the
public must be clear on this point: Vitamin E supplements won't help, and
might harm, so save your money. . . .”
JURY AWARDS $7.4 MILLION IN EPHEDRA SUIT
AP (June 25, 2004) A jury awarded $7.4 million to a woman who
suffered brain damage in a stroke two years ago after taking a diet
supplement that contained the now-banned herbal stimulant ephedra. The jury
found [June 23] that San Diego-based marketer Metabolife International acted
maliciously when it falsely told state and federal regulators that its
Metabolife supplement had no adverse effects and that the company had
comprehensive safety monitoring procedures. Rhea McAllister was awarded
$2.4 million in actual damages and $5 million in punitive damages.
Dangerous and Defective Products Ephedra
Court Upholds FDA s Denial of Saw Palmetto Health Claim.
On January 9, 2004 the
Court of Appeals for the District of Columbia affirmed the district court s
decision in Whitaker v. Thompson, upholding FDA s denial of a health claim
petition. The petition sought FDA authorization for a claim that Saw
Palmetto extract improves certain symptoms associated with mild benign
prostatic hyperplasia. The lawsuit challenged, on statutory and First
Amendment grounds, FDA s authority to subject dietary supplements bearing
disease treatment claims to the Act s drug approval requirements. FDA found
the Saw Palmetto claim related to treating, rather than preventing, an
existing disease, and therefore, not within the statute s definition of a
health claim. U.S. Court of Appeals Opinion:
industry fending off FDA
By Alice Dembner, Boston Globe Staff,
3/26/2004. Despite a recent federal ban of two harmful dietary
supplements, the herbal industry retains ...
diet supplement laws sought, MSNBC -
WASHINGTON - The US law enacted 10 years ago
to regulate vitamins, herbs and other dietary supplements needs
strengthening to better protect Americans from ...
Ephedra Battle Moves To The Courts
Nathan Vardi, Forbes.com, available at:
March 9, 2004.
NVE Pharmaceuticals today became
the first diet pill company to sue the federal government for banning
ephedra, the herbal supplement that has been linked to heart attacks and
deaths. . . . [K]nown for its Stacker 2 dietary supplements, made with
ephedra, NVE calls the government's ban "unlawful" and claims that ephedra,
an adrenaline-like stimulant also known as ma huang, helps people lose
weight and is safe when used as directed. . . .
The FDA first considered limiting sales of ephedra in 1997 after scientists
and consumer advocates started to raise concerns. While pharmaceutical
firms need to prove their drugs are safe with years of testing, dietary
supplement makers can sell pills over the counter unless the government can
prove their products are unsafe. . . .
CRACKDOWN ON PRODUCTS CONTAINING ANDRO, FDA Warns Manufacturers
To Stop Distributing Such Products
FDA Press Office, March 11, 2004.
HHS Secretary Tommy G. Thompson today
announced a crackdown on companies that manufacture, market and
distribute products containing androstenedione or, “andro,” which acts
like a steroid once it is metabolized by the body and therefore can pose
similar kinds of health risks as steroids. . . .
FDA Warns Distributors of Dietary Supplements
Promoted Online for Weight Loss, FDA Press Release
(April 1, 2004). Many of
these products claim to block starch, carbohydrates and fat calories,
while allowing weight loss without any changes in lifestyle.
“Dirty Dozen” Dietary Supplements Named,
Consumer Reports Issues List of
Potentially Dangerous Supplements (April 1, 2004). Despite known
hazards, many potentially dangerous dietary supplements are readily
available for purchase in stores and on the Internet, according to a new
report from Consumer Reports. Today, the magazine released its
"dirty dozen" list of dietary supplements that it says are too dangerous
to be on the market.
Finally, a ban on ephedra,
USA Today (April 12, 2004)
On Monday, a government ban on the sale of ephedra products finally went
into effect. A federal judge rejected a bid for further delay from
manufacturers who argued that the case against ephedra wasn't proved in
spite of at least 164 deaths and 16,000 adverse reactions since 1994.