Dietary Supplements

GENERAL

FDA Office On Dietary Supplements: http://www.cfsan.fda.gov/~dms/supplmnt.html

Proposal for Dietary Supplements Good Manufacturing Practices: http://www.cfsan.fda.gov/~dms/dscgmps3.html

FDA’s Ephedra webpage: http://www.cfsan.fda.gov/~dms/ds-ephed.html

Medline Plus: http://www.nlm.nih.gov/medlineplus/dietarysupplements.html

NIH Office of Dietary Supplements: http://dietary-supplements.info.nih.gov/

National Center for Complementary and Alternative Medicine: http://nccam.nih.gov/health/supplements.htm

Annual Bibliographies of Significant Advances in Dietary Supplement Research, NIH, Office of Dietary Supplements. http://ods.od.nih.gov/Research/Annual_Bibliographies.aspx

Dietary Supplement Fact Sheets, NIH. http://ods.od.nih.gov/Health_Information/Information_About_Individual_Dietary_Supplements.aspx

Dietary supplement background information http://ods.od.nih.gov/factsheets/DietarySupplements.asp

REGULATORY REQUIREMENTS

Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements; Proposed Rule: 68 FR 12158 (March 13, 2003) http://www.fda.gov/OHRMS/DOCKETS/98fr/03-5401.pdf.

Guidance for Industry: Statement of Identity, Nutrition Labeling, and Ingredient Labeling of Dietary Supplements Small Entity Compliance Guide http://vm.cfsan.fda.gov/~dms/ds-label.html#footnote

Draft guidance for industry: substantiation for dietary supplement claims
69 Federal 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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act.'' This draft guidance describes the amount, type, and quality of evidence that FDA recommends a manufacturer have to substantiate a claim under section 403(r)(6) of the Federal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
69 Federal 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 misleading claims.

FDA announces major initiatives for dietary supplements
FDA Media 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. http://www.fda.gov:80/bbs/topics/news/2004/NEW01130.html

ADVERTISING

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: http://www.ftc.gov/bcp/conline/pubs/buspubs/dietsupp.htm

REPORTS

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: http://www.npr.org/templates/story/story.php?storyId=4169957

“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. http://www.consumerreports.org/main/content/display_report.jsp?FOLDER%3C%3Efolder_id=419337&bmUID=1081000851071#

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: http://www.nap.edu/catalog/10882.html

Fact Sheet on FDA's Strategy for Dietary Supplements http://www.cfsan.fda.gov/~dms/ds3strfs.html

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). http://oig.hhs.gov/oei/reports/oei-01-00-00180.pdf

Health Effects of Androstenedione, FDA White Paper
http://www.fda.gov/oc/whitepapers/andro.html (March 11, 2004)

Institute of Medicine Report Urges More Reporting for Dietary Supplements http://www.iom.edu/report.asp?id=19578 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, Dietary Supplements: A Framework for Evaluating Safety, may be read or purchased at: http://www.nap.edu/catalog/10882.html

The Alternate Fix
Frontline (November 6, 2003) http://www.pbs.org/wgbh/pages/frontline/shows/altmed/. Frontline examines the controversy over complementary and alternative medicine.

NEWS

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. http://www.annals.org/cgi/content/full/0000605-200501040-00110v1

Vitamin E Supplements: Good in Theory, but Is the Theory Good?
E. Robert 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. . . .” http://www.acponline.org/journals/annals/vit_e.htm

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. http://news.findlaw.com/ap/o/1500/6-25-2004/20040625061503_27.html Dangerous and Defective Products Ephedra http://injury.findlaw.com/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: http://pacer.cadc.uscourts.gov/common/opinday/200401/040109.htm

Herbal industry fending off FDA http://www.boston.com/news/nation/articles/2004/03/26/herbal_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 ...

Tougher diet supplement laws sought, MSNBC - http://msnbc.msn.com/id/4600332/

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: http://www.forbes.com/2004/03/09/cz_nv_0309ephedra.html, 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. http://www.fda.gov/bbs/topics/news/2004/hhs_031104.html

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. http://www.fda.gov/bbs/topics/news/2004/NEW01045.html

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. http://www.usatoday.com/news/opinion/editorials/2004-04-12-ephedra_x.htm