A series by Bradley T. Wajda, D.O.
This is the 3rd installment in the series. We ended part two with a question- “does it matter where you get your multivitamin?” The answer is “more than you know”.
All supplements sold in the U.S. are required to adhere to Dietary Supplement Current Good Manufacturing Practice Guidelines (DS CGMP); however, the typical DS CGMP supplements that most people take frequently make the news due to quality issues- either not containing what they claim or containing contaminants.
- In May of 2013 Consumer Reports reported levels of lead in 9 out of 12 supplements that combine vitamin D with calcium. Those levels would have triggered warnings for reproductive risk under California Proposition 65.
- In the February 11, 2013, online edition of the Journal of the American Medical Association’s Internal Medicine there was a research letter from Kaiser Permanente scientists in Portland, Oregon. These scientists wanted to verify the potency of the community-obtained vitamin D3 pills they were using in a study and found that only one third of the pills analyzed fell within 10 percent of the claimed dose. The potency of these D3 samples was as low as 9 percent.
- In February of 2015 New York Attorney General Eric Schneiderman has sent cease-and-desist letters to GNC, Target, Wal-Mart and Walgreens asking them to stop the sale of allegedly mislabeled store-brand herbal products. Tests found only 21 percent of the supplements had DNA just from the herbs listed on the product labels. Seventy-nine percent of the products either had no DNA from the herb or included DNA from other plants.
- On August 17, 2019, the Organic Consumers Association ran a story about “fake” supplements being sold through a general retailer online.
Since 2010 the FDA has required all supplements sold in the United States to meet Current Good Manufacturing Practice guidelines (the CGMP). However, closer inspection reveals that these guidelines do not ensure a quality product:
- “Although there are new regulatory requirements for dietary supplements [the CGMP regulations of 2007], these products will not require FDA approval or submission of efficacy and safety data prior to marketing under the new regulation.” (Sadovsky, et al., 2008)
- “The responsibility for ensuring the validity of the product claims rests solely with the manufacturer.” (US National Library of Medicine, March 2011)
- “Unfortunately, it is possible for a company to manufacture a ‘bad’ supplement under the new ‘good’ manufacturing practices,” said Tod Cooperman, MD, President of ConsumerLab.com. “The GMPs require manufacturers to test all ingredients going into supplements but fail to specify the methods and standards by which ingredients are judged.”
- The GMPs do not set limits on the amounts of lead or other contaminants that can occur in supplements. Contamination is a well-known problem with some herbal and mineral supplements. The GMPs permit these limits to be determined by individual manufacturers.
- Similarly, manufacturers are left to choose the appropriate methods and standards for judging the identity of ingredients (there are no formally validated tests).
- 30% of CGMP supplements tested yearly by ConsumerLab.com have a quality problem.
Despite such lenient requirements set by the CGMP, Natural Products Insider reports that nearly 19 percent of dietary supplement firms are cited by inspectors for violations of the CGMP yearly.
So where do you get your supplements? You get them from an extensively tested and credentialed manufacturer. One that maintains such high standards that they have rejected entire batches of supplements that contain any potential issues that may cause a product to be less than the best. That manufacturer is Body Wise.
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