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We see them advertised on TV, in late night infomercials, in our pharmacies and nutrition stores all the time. Many of us, adults and children alike, take them because we believe they are keeping us healthy or in some way give us the impression of leading a healthier lifestyle. With so many of them available making claims about the benefits to our health, weight loss, weight gain, healthy bones and joints, even those out there that improve one’s mood or sex life, how do all these dietary supplements make it on to our store shelves and how are they regulated? Are they safe?
According to National Health Interview Survey in 2007, 17.7 percent of American adults had used these types of products in the past 12 months. The most popular of these products used by adults in the past 30 days were fish oil/omega 3/DHA (37.4 percent), glucosamine (19.9 percent), echinacea (19.8 percent), flaxseed oil or pills (15.9 percent), and ginseng (14.1 percent). Data collected between 2003 and 2006 in the National Health and Nutrition Examination Survey (NHANES) that covered all types of dietary supplements indicate that 53 percent of American adults took at least one dietary supplement, most commonly multivitamin/multimineral supplements (taken by 39 percent of all adults). Women were more likely than men to take dietary supplements. 1
In October 1994, the Dietary Supplement Health and Education Act (DSHEA) was signed by President Bill Clinton in which congress defined the terms “dietary supplement” and “new dietary ingredient” as components of dietary supplements. Dietary supplements are products taken by mouth that contain a “dietary ingredient” intended to supplement the diet.
Also, manufacturers and distributors who wish to market dietary supplements that contain “new dietary ingredients” must notify the Food and Drug Administration about these ingredients. The notification must include information that a dietary supplement containing a “new dietary ingredient” will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling and are defined, in part, as products (other than tobacco) intended to supplement the diet that contain one or more of the following:
These supplements 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 whatever their form may be, DSHEA places dietary supplements in a special category under the general umbrella of “foods,” not drugs, and products must be labeled as dietary supplements that are intended for ingestion. They cannot be represented for use as a conventional food or as a sole item of a meal or the diet. Because dietary supplements are under the “umbrella” of foods, FDA’s Center for Food Safety and Applied Nutrition (CFSAN) is responsible for the agency’s oversight of these products as opposed to the Center for Drug Evaluation and Research (CDER) that are charged with regulating and approving drugs as we have mentioned in an earlier post (see The FDA Process: How Drugs Are Approved and Monitored).
We have mentioned in previous posts that one of the responsibilities of the FDA is to protect the public health by assuring the safety, efficacy of human and veterinary drugs, biological products, medical devices, our nation’s food supply 3. Prior to DSHEA in 1994, dietary supplements were subject to the same regulatory requirements as were other foods. This new law, which amended the earlier Federal Food, Drug, and Cosmetic Act, created a new regulatory framework for the safety and labeling (see below) of dietary supplements under a different set of regulations than those covering “conventional” foods and drug products.
The DSHEA requires that a manufacturer (firm) is responsible for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not adulterated or misbranded. This means that dietary supplements do not need approval from FDA before they are marketed. In some cases a new dietary ingredient, pre-market review for safety data and other information is required by law 4.
Manufacturers, however, need to register themselves with FDA before producing or selling supplements. In June, 2007, FDA published comprehensive regulations for Current Good Manufacturing Practices (sometimes referred to as cGMP) for those who manufacture, package or hold dietary supplement products. These regulations focus on personnel, the physical plant and grounds, the equipment that is used, requirements to establish a production and process control system, requirements for quality control, requirements for components, packaging, labeling as a dietary supplement, distribution, records and recordkeeping 5. These quality control measures ensure the identity, purity, quality, strength and composition of dietary supplements2.
The FDA is responsible for taking action against any adulterated or misbranded dietary supplement product after it reaches the market. As with other products where the FDA is involved, the manufacturer, packer, or distributor whose name appears on the label of a dietary supplement marketed in the United States is required to submit to FDA all serious adverse event reports associated with use of the dietary supplement in the United States4.
FDA regulations require that certain information appear on dietary supplement labels. Information that must be on a dietary supplement label includes five statements that are required: 1) the statement of identity (name of the dietary supplement), 2) the net quantity of contents statement (amount of the dietary supplement), 3) the nutrition labeling, 4) the ingredient list, and 5) the name and place of business of the manufacturer, packer, or distributor. In addition, each dietary supplement must have nutrition labeling in the form of a “Supplement Facts” panel similar to a food label. This label must identify each dietary ingredient contained in the product. Ingredients not listed on the “Supplement Facts” panel must be listed in the “other ingredient” statement beneath the panel. The manufacturer is responsible for ensuring that the “Supplement Facts” label and ingredient list are accurate, that the dietary ingredients are safe, and that the content matches the amount declared on the label, and the disclosure of key allergens is required (Food Allergen Labeling Act).
As I mentioned earlier, we see ads in print and on TV about claims some of these manufacturers make about their products and that if/when we take them we can become stronger, lose weight, get healthy, etc. The responsibility for ensuring the validity of these claims rests with the manufacturer, FDA, and, in the case of advertising, with the Federal Trade Commission (for more information on the FTC see their website). Some can be can be misleading. Therefore, a product sold as a dietary supplement and promoted on its label or in labeling as a treatment, prevention or cure for a specific disease or condition, would be considered an unapproved–and thus illegal–drug. So labeling and safety issues become very important issues when a manufacturer markets a dietary supplement.
By law, manufacturers may make three types of claims for their dietary supplement products: health claims, structure/function claims, and nutrient content claims.
When a manufacturer makes a structure/function claim on a dietary supplement label, a statement or “disclaimer” is required by law (DSHEA). The manufacturer is responsible for ensuring the accuracy and truthfulness of these claims; they are not “approved” by FDA. For this reason, if a dietary supplement label includes such a claim, it must state in a “disclaimer” that FDA has not evaluated this claim. The disclaimer must also state that this product is not intended to “diagnose, treat, cure or prevent any disease,” because only a drug can legally make such a claim.
So, are you worried or concerned yet? Don’t be. I know this is a lot of information to digest and we consider it part of our core values here at Recall Center to educate in order to make you a more informed consumer.
Yes, it’s true that dietary supplements do not require testing for efficacy. Most of the dietary supplements, like vitamins and minerals, have been around for a while, are considered to be safe, and actually do as they claim. All products are in danger of some type of contamination during a manufacturing process, just like any approved drug (prescribed or over-the-counter) that goes through rigorous testing. Some herbal medicines may contain very little of what the company claims or anything of value at all 7. And you should be at least a little curious when an infomercial in the middle of the night is telling you, for example, to take a supplement and you can lose a lot of weight. More likely than not, if something sounds too good to be true and hard to believe, it most likely is. Some ingredients you see listed on the labels may interact with drugs you are taking or may just have a negative effect, depending on whatever ails you, so always check with your doctor. The point is, as a consumer, keep yourself informed, ask questions, read the labels before you buy, and do the research. There are plenty of resources to find information you are looking for and in the end you will feel better about the decisions you make regarding your own health.
If you think you have suffered a serious harmful effect or illness from a dietary supplement, the first thing you should do is contact or see your healthcare provider immediately. Then, you or your health care provider can report this by submitting a report through the Safety Reporting Portal. If you do not have access to the internet, you may submit a report by calling FDA’s MedWatch hotline at 1-800-FDA-1088.
National Institutes of Health. National Center for Complementary and Alternative Medicine. Using Dietary Supplements Wisely. Last Updated: March 2013. Available at: http://nccam.nih.gov/health/supplements/wiseuse.htm. Accessed on April 21, 2014. ↩
U.S. Food and Drug Administration. Food: Q&A on Dietary Supplements. Last updated: March 20, 2014. Available at: http://www.fda.gov/Food/DietarySupplements/QADietarySupplements/default.htm. Accessed on: April 20, 2014. ↩
U.S. Food and Drug Administration. About FDA: What We Do. Last updated: September 19, 2013. Available at: http://www.fda.gov/aboutfda/whatwedo/. Accessed on: April 21, 2014 ↩
U.S. Food and Drug Administration. Food: Dietary Supplements. Last updated: March 20, 2014. Available at: http://www.fda.gov/Food/Dietarysupplements/default.htm. Accessed on: April 20, 2014. ↩
U.S. Food and Drug Administration. Food: Guidance for Industry: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Small Entity Compliance Guide. Last updated: February 24, 2014. Available at: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/ucm238182.htm. Accessed on: April 20, 2014. ↩
U.S. Food and Drug Administration. Food: Label Claims for Conventional Foods and Dietary Supplements. Last updated: February 26, 2014. Available at: http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm111447.htm. Accessed on: April 22, 2014. ↩
Newmaster SG, Grguric M, Shanmughanandhan D, Ramalingam S, Ragupathy S. DNA barcoding detects contamination and substitution in North American herbal products. BMC Med. 2013 Oct 11;11:222 ↩