{"id":475,"date":"2014-07-21T10:08:50","date_gmt":"2014-07-21T17:08:50","guid":{"rendered":"https:\/\/skepticink.com\/health\/?p=475"},"modified":"2014-07-21T11:06:30","modified_gmt":"2014-07-21T18:06:30","slug":"recent-stories-tainted-dietary-supplements","status":"publish","type":"post","link":"https:\/\/skepticink.com\/health\/2014\/07\/21\/recent-stories-tainted-dietary-supplements\/","title":{"rendered":"Some Recent Stories of Tainted Dietary Supplements"},"content":{"rendered":"

By William M. London<\/strong><\/p>\n

I have stories to share with you about dietary supplements spiked with approved and unapproved drugs, but I haven\u2019t found any stories to share with you about approved drug products spiked with supplements.<\/p>\n

What does that tell you about dietary supplements?<\/p>\n

In the United States, under the Dietary Supplement and Health Education Act of 1994 (DSHEA)<\/a>, dietary supplements are supposed to contain \u201cdietary ingredients\u201d alone or in combinations. Ingredients can include vitamins, minerals, amino acids, enzymes, tissues from organs\/glands, several other substances that are supposedly dietary, and botanical preparations\u2014which, by their nature, contain a variety of untested chemicals in amounts that vary significantly from extract to extract.
\n<\/a><\/p>\n

While pharmaceutical companies are required to put chemicals through a rigorous laboratory and clinical testing process before the federal Food and Drug Administration (FDA) will consider them for approval as drug products, you don\u2019t need any premarket approval in order to sell untested combinations of many different chemicals as dietary supplements. You don\u2019t need to do any testing to establish that a dietary supplement product you want to bring to market is safe and effective for an intended health-related purpose. You can legally label your supplement product with claims about: (1) nutrient content (which often are inaccurate<\/a>), (2) health (including dubious assertions such as \u201csupports immune health\u201d or \u201csupports digestive health\u201d), and (3) maintaining normal body structure or function (e.g. \u201cpromotes healthy joints and bones\u201d). You just have to<\/a>:<\/p>\n

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  1. Avoid labeling the product as a treatment, prevention or cure for a specific disease or condition.<\/li>\n
  2. Label the product appropriately: include a descriptive name; indicate that it\u2019s a “supplement;” provide the name and place of business of the manufacturer, packer, or distributor; give a complete list of ingredients and the net contents of the product (and don\u2019t expect regulatory actions if the dosage of ingredients doesn\u2019t match what the label says).<\/li>\n
  3. Notify the federal Food and Drug Administration (FDA) if your supplement contains a dietary ingredient not sold in the U.S. before DSHEA was passed and explain why the ingredient ought to be safe (with no need to test the ingredient for safety or effectiveness for any intended purpose).<\/li>\n
  4. Include on the label when making structure\/function claims a disclaimer that Peter A. Lipson, M.D. has called the Quack Miranda Warning<\/a>: “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.”<\/li>\n
  5. Avoid false advertising.<\/li>\n<\/ol>\n

    By taking those five precautions, marketers can legally sell chemical concoctions (that should be viewed as drugs) as dietary supplements. And they often get away with selling unsafe chemical concoctions without taking all those precautions. But when dietary supplement companies authorize or allow ingredients (such as imports from China) not permitted under DSHEA to be included in product formulations, they leave themselves open to regulatory actions.<\/p>\n

    Healthy Life Chemistry By Purity First B-50<\/b><\/p>\n

    FDA conducted laboratory analysis of the supplement Healthy Life Chemistry By Purity First B-50, which was sold on various websites and in retail stores, and found that it contained two potentially harmful, anabolic steroids\u2014methasterone, a controlled substance, and dimethazine. The analysis was carried out after FDA received 29 reports of adverse incidents associated with use of the product and one hospitalization. Reported problems included:<\/span><\/p>\n