As we move forward in cold and flu season, the mass marketing of products gets going in full-force. There are the old familiars-decongestants, antihistamines, cough syrups and analgesics (pain and fever-reducers)-that have been around for a long time and are regulated as drugs. But there are also all kinds of alternative supplements that are promoted. According to a study published in the New England Journal of Medicine, October 15, 2015, and reported on by Medscape Infectious Diseases on its website, dietary supplements send an estimated 23,005 Americans to the emergency department and result in 2,000 hospitalizations each year.
For example, one of the newer cold/flu remedies to hit the market are products made with elderberries. The cooked blue/black berries have been used in teas, liquid extracts and capsules. The National Center for Complementary and Integrative Medicine, (NCCIH) reviews many dietary supplements and reports the most up-to-date research on the products. Regarding the elderberry and related elder products, it states:
- There have been some small studies that show the elderberry may relieve flu symptoms, but the evidence is not strong enough to support use of the berry.
- A few studies have suggested that a product containing the elder flower and other herbs can help treat sinus infections when used with antibiotics, but further research is needed.
- No reliable information is available on the effectiveness of elderberry or elder flower products for other uses.
- The NCCIH warns that uncooked or unripe elderberries are toxic and cause nausea, vomiting, or severe diarrhea. Only the blue/black berries of elder are edible. Furthermore, elder flower can have diuretic effects, so caution must be used if you are also taking drugs that increase urination.
Dietary supplements (products that may contain vitamins, minerals, amino acids, herbs or other plant or botanicals) are not regulated in the same stringent manner as are products that are considered drugs. However, people may use dietary supplements for the same reasons that they might take a medication.
It is important that you understand what is in a supplement that you are taking to be sure it will not interact with medications that you take, worsen a health condition that you might have, or if you expect to have surgery, or are pregnant or nursing. The regulation of supplements (by the Food and Drug Administration-FDA) differs from the regulation of drugs (both prescription and over-the-counter) in that it is up to the manufacturer to ensure that their products are safe and that the label information is truthful and not misleading. Manufacturers of dietary supplements do not have to provide study data which demonstrates their safety or effectiveness before the product comes to market. The oversight for dietary supplements is more passive in that the evaluation of a product and its safety is done by the FDA after the product is on the market. The FDA keeps track of any side effects reported by consumers, health care providers and supplement companies. If the FDA finds the product unsafe, it will remove it from the market. The Federal Trade Commission (FTC) is responsible for regulating product advertising and requires all information be truthful and not misleading.
You might wonder, what about the claims dietary supplements make? Are they true? There are three types of claims that dietary supplements can make on their products. They are: health claims; structure/function claims and nutrient content claims. Different requirements are in place for each type of claim. For example, if a product makes a claim about how a supplement affects the structure or function of the body, the claim must be followed by the statement, “This statement has not been evaluated by the U.S. FDA. This product is not intended to diagnose, treat, cure or prevent any disease.”
The main messages about supplements are: Know what you are taking; Know how it might interact with other medications you take; and what are the potential side effects to watch for. If you have had a reaction or side effect from a dietary supplement you have taken, you can report it to the Safety Reporting Portal, http://www.safetyreporting.hhs.gov.
There are a number of reliable resources for learning about a supplement. National Center for Complementary and Integrative Health (NCCIH), www.nccih.nih.gov; Office of Dietary Supplements (ODS), http://ods.od.nih.gov; Center for Food Safety and Applied Nutrition (CFSAN), http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CFSAN or the National Library of Medicine’s MedlinePlus, http://www.medlineplus.gov.
Residents of the Quinnipiack Valley Health District (Bethany, Hamden, North Haven and Woodbridge) without internet access can call QVHD, 203 248-4528, for written information on this topic or a specific supplement. The information in this column is provided for educational purposes only and is not intended to be construed as medical advice or replace the advice of your health care provider.