Are Your Supplements Safe?

In a word, YES! You may have seen recent media reports that question whether supplements are safe and we want to clear up any misconceptions. The vast majority of supplements are inexpensive, effective, and safe. The most important things to know about supplement safety are as follows:

  1. Claims that supplements are unregulated are false. Supplements are regulated under the Dietary Supplement Health and Education Act of 1994. According to the FDA’s own website the “FDA regulates both finished dietary supplement products and dietary ingredients” and the “FDA is responsible for taking action against any adulterated or misbranded supplement product after it reaches the market.” (1)
  2. The FDA’s website includes tips for using dietary supplements, information on how to report an adverse event, and what is required for a new dietary ingredient to come to market.(1)
  3. Pre-market approval of each product is not required because supplements are natural substances found in the body and in food and are regulated as such. Drugs require pre-market approval because most of them are chemicals not normally found in the body that require a higher degree of scrutiny.
  4. Recent actions by the Department of Justice (DOJ) relate to adulterated products which, by definition, are not supplements at all. They often contain drugs or unapproved dietary ingredients and are being marketed as supplements by companies with unethical business practices.
  5. Tainted products show up almost exclusively in three categories: sexual performance, weight loss, and sports supplements. (2)None of the recent actions by the DOJ against supplement companies are for vitamins, minerals, probiotics, fish oils, herbs, or most other products that people purchase at a store like ours.
  6. The overwhelming majority of supplement manufacturers are reputable businesses that follow FDA guidelines, including Good Manufacturing Practices (GMPs). GMPs require certain standards for identification, purity, strength, and composition of raw materials. Many companies we carry go beyond FDA requirements with additional certifications by third parties like USDA certified organic, NSF, Eurofins, and United States Pharmacopeia (USP).

Above are the most important things to know about supplement safety, but we also want to specifically address certain things that you may have heard in the news over the last year. Often, reporting is one-sided and sensationalized for the purpose of ratings and responses by the scientific community and industry experts do not get on the air. We may cite a response by a specific organization below, but keep in mind that many organizations came out against each allegation, including the Natural Products Association, the American Botanical Council, the Council for Responsible Nutrition, the American Herbal Products Association and many doctors and scientists. All of the industry associations support regulation significant instances of late and the real story behind them:

  1. Early this year, the New York Attorney General issued cease and desist letters to four large retailers including GNC, Target, Walgreen’s, and Walmart demanding that they stop the sale of certain herbal supplements. The demand was based on DNA bar code testing and the AG’s office claimed that the products contained unrecognized ingredients and did not contain what was claimed on the label. The main objection from industry experts was that DNA bar code testing is not a valid testing method for herbal extracts, which constituted most of the products tested. Herbal extracts make “the naturally occurring constituents more available, and there is no reason to retain intact (and therefore detectable) DNA to do so. There is no relationship between the quality of an herbal extract and the presence of detectable DNA.” Many other experts noted that other methods such as chromatography should have been used to confirm the results but were not.(3)
  2. Also within the last year, the FDA sent warning letters to manufacturers selling supplements that contained BMPEA, DMAA, and DMBA, all illegal substances found in sports supplements that do not meet the statutory definition of a dietary ingredient. The FDA was criticized by industry experts and others for not ensuring these products were immediately removed from shelves. The FDA also sent warnings to several companies for selling pure, powdered caffeine supplements that presented an unreasonable risk of illness or injury to consumers.
  3. In October, the Oregon Attorney General sued GNC, accusing them of selling 22 workout and fat-burning supplements that contained picamilon, a prescription drug in Russia used to treat neurological conditions. It also accused them of selling supplements containing BMPEA, an amphetamine-like synthetic ingredient in supplements, even though it knew as far back as 2007 that the ingredient was not legal. Industry experts agree with the removal of these illegal products from the market, but question why the FDA isn’t taking action rather than leaving it to the states.
  4. The New England Journal of Medicine recently published a report that supplements were responsible for 23,000 adverse events per year, based on data taken from 63 emergency departments in the US from 2004 to 2013. The NPA challenged the findings because the laws that regulate supplements have a clear mechanism for reporting adverse events, as noted on the FDA’s website. (1) Data from this reporting shows a very different picture—that there were only 3249 events reported in 2012. This is an extremely low number given the widespread use of supplements, demonstrating their safety. (4)
  5. In November, the DOJ and four other government agencies announced actions against several companies, most notable USPLabs, maker of weight loss and sports products like Jack3d and Oxy Elite Pro. The products contained illegal ingredients and did not conform to the definition of a dietary supplement. These “supplement companies” are named as such in the press, but don’t really represent the supplement industry because they do not meet the legal definition of a supplement.

A few things are clear from the above that I want to emphasize: supplements, by and large, are very safe and effective. This is why millions of Americans, including doctors and other health professional, use them. There are laws in place to regulate products that do not conform to the definition of a supplement and have synthetic, illegal, or new, unapproved dietary ingredients in them. The majority of “bad actors” can be found in the sports, weight loss, and sexual performance categories and it is best to use a “buyer beware” approach to products used for these purposes. Many stories in the news have inaccurate or exaggerated information, or represent a very small part of the supplements market.

We strive to do the research for you, and buy only from companies with excellent standards. Many of the companies we carry go above and beyond FDA requirements, and have solid science behind their products. The FDA has a video on supplements that states that “it is rare for vitamins and minerals to be contaminated with drugs”, so don’t assume that a few bad actors constitute the entire industry. (5)Buy supplements from a reputable source. When you see products with names like “Get it Up”, “Magic Power Coffee”, and “Fat Zero”, be skeptical. And last of all, don’t forget why you take supplements; a) they contain substances naturally found in the body and in foods b) they work with, rather than against, the body and c) they produce good results without side effects.

(1)http://www.fda.gov/Food/DietarySupplements/

(2)http://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?sd=tainted_supplements_cder&displayAll=false&page=13

(3)http://www.ahpa.org/Default.aspx?tabid=507

(4)http://www.npainfo.org/App_Themes/NPA/docs/press/PressReleases/NEJM%20Response%20-%20Supplement%20Use%20ER%20Visits%20Final.pdf

(5)http://hprc-online.org/blog/decoding-the-dietary-supplement-industry