The Federal Food, Drug and Cosmetic Act defines a supplement as a vitamin, mineral, herb or other botanical, amino acid, or dietary substance for use by man to supplement the diet by increasing the dietary intake, concentrate, metabolite, constituent extract, or combination of preceding substances. With the astronomical variety of supplements being marketed it comes as a surprise to many that these products are not fully regulated by the Food and Drug Administration (FDA). Supplements fall under the Dietary Supplement Health and Education Act (DHSEA) of 1994 that prohibits manufacturers and distributors from marketing false or unsafe products. Prior to distribution, companies selling supplements must establish a safety plan and proper labeling to meet the DHSEA regulations. Although meeting these regulations are required, the FDA does not test these supplements to verify that what is on the ingredient list is actually being sold.
While the FDA does not regulate such products, there are independent organizations that test these products to determine if the ingredients on the label are in fact what the supplement contains without the addition of ingredients not listed. Unfortunately, these independent companies do not test to see if the supplement has a particular health effect or if it is safe. Organizations such as Consumer Labs, NSF Internationals and US Pharmacopeia all have their own seal of approval that can be found on the front of the supplement bottle indicating that the specific supplement has been tested.
Under federal law dietary supplements cannot be promoted for the treatment of disease because they are not proven to be safe and effective. Label claims such as “address nutrient deficiency,” “supports health,” “shrinks tumors,” “this product does it all” and scientific words being used like “scientific breakthrough” and “secret Ingredient” must be followed by this disclaimer “This supplement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease”. These label claims can be tip-offs of a company looking to take advantage of the limited knowledge of the general public and that supplements are simply not fully regulated by the FDA.
Before purchasing a supplement, it is important to speak with a doctor, registered dietitian or a pharmacist to determine a person’s nutrition needs. Factors to consider may include age, diet, current medical conditions or medical conditions a person may be at risk for such as osteoporosis, heart disease, kidney disease, cancer, pregnancy and more. It is also important to do your homework before purchasing any type of over the counter supplement. Questions a person should ask include: What does this supplement do? What are the risks and the benefits? How much do I take? How long do I take it? When do I take it?
When researching supplements, it is important to consider the risks. Speaking with a doctor, registered dietitian or pharmacist before taking a supplement will be helpful in determining which are safe for specific medical conditions. Many supplements can have interactions with current medications a person may be taking. Examples include vitamin C and E with cancer treatments; antidepressants and birth control with St. John’s Wort; vitamin K with Coumadin; ginseng with Heparin; anticoagulants and NSAIDS; gingko biloba with high blood pressure medications. Health conditions to be aware of when taking supplements include surgery, pregnancy, breastfeeding, heart disease, high blood pressure, and gastrointestinal issues. For example, during pregnancy a prenatal vitamin is recommended as consuming the recommended dosage of specific vitamins like folate can prevent long term birth defects such as spina bifida.
If a potential problem is suspected with a supplement it can be reported to the Federal Trade Commission, State Attorney’s General Office, State Department of Health, or your Local Consumer Protection Agency. If an illness is suspected to be a result from taking a supplement, report to your doctor immediately and a compliant can be filed with the FDA online.
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Medication and Supplements that can raise your blood pressure. Mayo Clinic Website. https://www.mayoclinic.org/diseases-conditions/high-blood-pressure/in-depth/blood-pressure/art-20045245 Accessed March 26, 2019
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Mixed Medications and Dietary Supplements Can Endanger Your Health. FDA website. https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm420349.htm. Accessed March 26, 2019
Guidance for Industry. Distinguishing Liquid Dietary Supplements from Beverages. FDA website. https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/UCM381220.pdf . Accessed March 26, 2019.