Unregulated Dietary Supplements May Be Prescription for Health Disaster

A new study from The New England Journal of Medicine found that dietary supplements, including vitamins, minerals, and herbs, send at least 23,000 Americans to the hospital each year, and hospitalize more than 2,000 annually. Authors examined data from 63 hospitals from 2003-2014 in drawing their conclusions that have health advocates renewing calls for stronger FDA oversight of supplement makers and supplement safety. Authors estimate the actual number of ER visits and hospitalizations is probably much higher since many people fail to tell ER physicians that they are regularly taking dietary supplements, and they fail to attribute their negative health symptoms to supplement use since supplements are supposed to be “healthy”.

Study authors warn “natural” does not equal “safe”

People take dietary supplements for a variety of reasons including weight loss, increased energy, for ED (erectile dysfunction) issues, and to enhance sports performance, just to name just a few. People mistakenly assume that since supplements are promoted as a health aide that they are harmless. Manufacturers use words like “natural”, “organic” or “no added ingredients” to evoke trust and imply that a product is safe when, in fact, there is no legal requirement that supplements be tested for their safety and effectiveness before being sold on the market.

The Dietary Supplement Health and Education Act (DSHEA) of 1994 severely limited any FDA role in the industry so the FDA can only step in and do something once a problem already exists. FDA approval is not required since dietary supplements are deemed neither “food” nor a “drug”, so the best advice when it comes to dietary supplements is buyer beware. Many dietary supplements have no recorded data to back up health claims, nor any rigorous safety testing or studies to demonstrate the effectiveness of these products.

Andrew Geller, a CDC medical health officer, explained, “Many Americans take dietary supplements in an effort to stay healthy, but these products can cause harm for some people.” Many products do not contain what they say they do, and others do not list what they actually do contain. Earlier this year, the New York Attorney General who went after big-name retailers whose store-brand supplements contained only 21% of the claimed ingredients. https://bubalolaw.wpengine.com/blog/2015/03/states-attorneys-general-take-up-fight-against-fraudulent-dietary-supplements/

And many people may not be getting the health benefits they bargained for because supplements may actually cause harm instead. Check out more on this subject in our March 2015 blog article: https://bubalolaw.wpengine.com/blog/2015/03/proceed-with-caution-before-you-swallow-all-the-hype-about-dietary-supplements/

FDA warning about imported dietary supplements and non-prescription drugs

The FDA is also warning consumers about health scammers selling fraudulent imported dietary supplements and non-prescription drugs. People who shop by non-traditional means like on the internet, at flea markets and ethnic stores, who may not speak English very well or at all, and who may be more likely to seek out dietary supplements like vitamins, minerals and herbs rather than use traditional medicine, are being targeted by health scammers.

We recommend that before buying an imported product be suspicious of products that claim a “quick fix”, “miracle cure”, or that they are “all-natural” or “FDA approved”. This last claim is a huge red flag that the product is fraudulent since supplements are not subject to FDA approval.

Let your doctor and pharmacist know what dietary supplements you are taking

Until we know for sure what is contained in dietary supplements, and whether they are a healthy addition to your diet, the best advice is never to take any before talking to your doctor or health provider. FDA National Health Fraud Gary Coody, R. PhD., cautions, “Remember, dietary supplements are not drugs. They are not substitutes for the drugs your health care professional prescribes. And you should let your health care professional know what supplements you are taking, because they may interact in a harmful way with prescribed medications or keep a prescribed drug from working.”

We also recommend keeping your pharmacist regularly up to date about any drugs, dietary supplements or other products to help you successfully avoid any drug interactions.

You can also check the FDA website to see if there has been any action taken against a supplement when deciding whether to add it to your dietary routine.

Dietary supplements must be regulated

We strongly advocate for a change in the law giving the FDA greater authority to regulate dietary supplements to ensure they contain the ingredients their labels say they do and do not contain any chemicals or other ingredients not listed on the label. The FDA also needs the authority to remove supplements from the market to keep dangerous products out of consumers’ hands. We also strongly believe that dietary supplements should undergo rigorous safety and product testing similar to prescription drugs to ensure their safety and effectiveness of what is claimed on the label. Dietary supplements should contain an accurate list of their ingredients as well as warning labels about any health risks or adverse effects.

Consumer advocates would also like to see dietary supplements in child-resistant packaging since there are many reports of child poisonings who accidentally ingest dietary supplements.

Report any adverse reactions to the FDA

If you or a loved one has a bad reaction to a dietary supplement or non-prescription drug, the FDA encourages you to file an adverse event report through their reporting system which allows it to document and investigate adverse reactions to try to remove harmful products from the market. Please report any adverse reactions by calling your state’s Consumer Complaint Coordinator found here: http://www.fda.gov/Safety/ReportaProblem/ConsumerComplaintCoordinators/default.htm or online at https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home.