Dietary Supplements Efficacy, Safety and Regulations
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This document provides an overview of dietary supplements, including their efficacy, safety, and regulations. It defines supplements as products intended to supplement the diet that contain dietary ingredients like vitamins, minerals, herbs and botanicals. Supplements are distinguished from drugs in that drugs must undergo FDA approval, while supplements are only intended to affect the structure or function of the body. The document also discusses common supplements, safety issues, labeling requirements, and how to choose quality supplements.
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Dietary Supplements Efficacy, Safety and Regulations
- 1. Introduction to Dietary Supplements: Efficacy, Safety and Regulations Ali Alhammad PhD Student President, VCU-ISPOR Chapter Department of Pharmacotherapy and Outcome Sciences School of Pharmacy, VCU Saudi Student Organization (SSO) April 8, 2011
- 11. Effectiveness
- 17. Ginkgo
- 23. Safety of DS
- 31. Regulation of DS
- 38. Labeling of Dietary Supplements
- 43. How To Choose…
- 44. How To Choose…
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- when CoQ10 is taken with fat, the action of CoQ10 exceeds what is would be if not taken with fat.
- "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."
- 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if a list of references is provided, the citations cannot be traced, or if they are traceable, the studies are out-of-date, irrelevant, or poorly designed.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.
- U.S. Pharmacopeia’s (USP) new Dietary Supplement Verification Program (DSVP) is confusing and could mislead consumers into thinking the group’s seal means more than it really does, according to the Center for Science in the Public Interest (CSPI). The USP certification mark, which will begin appearing on at least one brand of dietary supplements later this year, means that USP vouches for the presence, quantity, and purity of a supplement’s ingredients—and not the supplement’s safety or possible benefits. Neither the mark, which says “Dietary Supplement Verified,” nor the accompanying explanation make that distinction clear, says CSPI. “ We applaud USP for trying to help consumers identify high-quality dietary supplements,” said CSPI senior nutritionist David Schardt. “But we are concerned that some consumers will assume that the USP mark means the product is safe and beneficial. USP risks losing its credibility if it is not clear about what is being certified and what is not.” For instance, says Schardt, if a bottle of ginseng pills bears the new USP seal, it means that USP certifies that the product contains the amount of ginseng listed on the label and that the ingredient is free from contamination. It does not mean that USP has tested and verified that ginseng provides additional energy or that it’s safe. A second major consumer group, the National Consumers League, expressed a similar concern about the clarity of USP's certification mark. “We hope that USP will go back to the drawing board and design something that will be clearer and convey to consumers that the product has not been tested for safety or efficacy,” said the League’s president, Linda Golodner.