Carolyn Vachani, RN, MSN, AOCN
The Abramson Cancer Center of the University of Pennsylvania
Last Modified: January 16, 2008
There is quite a bit of confusion among consumers as to how dietary supplements are “regulated” by the U.S. Food & Drug Administration. Let’s review the facts about this regulation.
The U.S. FDA categorizes vitamins, minerals, amino acids, herbals, and other botanicals as dietary supplements. Other supplements that fall under the FDA regulations include hormones, such as melatonin, glucosamine, chondroitin, and SAMe. You can tell that an item falls under these regulations because the label will say “Supplement Facts”.
If sales are any proof, yes. In 2006, Americans spent over 23 billion dollars on dietary supplements. A 2002 survey found that about 40% of participants had used a vitamin, mineral or other dietary supplement in the previous month. About 44% of participants who are 40 years of age or older reported using more than one supplement.
Consumers are often surprised to learn that DSs are less tightly regulated than prescription or over-the-counter medications, food additives, and even the food we buy. The Dietary Supplement Health and Education Act of 1994 (DSHEA) essentially gave the FDA less oversight of the dietary supplement industry.
Under the DSHEA, product manufacturers are responsible for assuring safety and quality of their products, and for determining that any claims made about the supplement are not false or misleading. The manufacturer is responsible for establishing its own manufacturing guidelines to ensure safety and that what is on the label is what is actually in the product.
Unfortunately, this is not the case for far too many supplements. Some studies estimate that 60% of products do not contain what the label says they do. In some cases, there may be more or less of the active ingredient. In others, there may be unsafe additives such as less expensive alternatives, other active medications, or additives with their own toxicities. The U.S. FDA has instituted new regulations to have better oversight of the quality, strength, composition and purity of the products. The regulations will institute current good manufacturing practice requirements which will gradually be phased in, with all manufacturers meeting these standards by summer 2010. In 2008, manufacturers are required to report adverse reactions to the FDA, a practice that was previously voluntary. The new regulations fall short of assuring safety or toxicity of the active ingredients, as is done for pharmaceutical and over the counter medications, but at least it is a start.
The U.S. Pharmacopeia has established standards for purity, strength, labeling and quality. Manufacturers can show that they comply with these voluntary guidelines by putting a “USP” logo on the product label. While this is not guarantee of quality, it may be a sign of good practices by the manufacturer.
The take-home message is that consumers need to use caution, purchase supplements from reliable retailers, and report any side effects to the U.S. FDA.
Absolutely! Surveys have shown that many patients don’t tell their healthcare teams about supplement use. They may not think it is important or think that their providers will not understand. If you have any literature on what you are taking about, bring it to your appointment for your provider to see. Tell them what you are taking it for- perhaps they have something else that may be helpful.
Some supplements may interfere with cancer therapies or actually make certain side effects worse. Some can increase the risk of bleeding, which is a concern if your platelet count is low. And, unfortunately, some are a sham, promoted by unscrupulous retailers preying on cancer patients. Your healthcare team can help you make an educated decision about which supplements you want to use.