BBB National Programs Archive

NAD Recommends Prescription Vitamins Modify, Discontinue All Claims, Testimonials at Issue for ‘Statinzyme’

New York, NY – Dec. 19, 2013 – The National Advertising Division has recommended that Prescription Vitamins, LLC, modify or discontinue all claims at issue in a recent NAD inquiry, including claims that the product will prevent or relieve the “side effects” of cholesterol-lowering prescription medications or lower one’s chances of a heart attack or stroke.

NAD is an investigative unit of the advertising industry’s system of self-regulation and is administered by the Council of Better Business Bureaus. The claims at issue were challenged by the Council for Responsible Nutrition.

Statinzyme is formulated from ingredients that include CoQ10, EPA, DHA, flax seed oil, vitamin D3, primrose oil (GLA), resveratrol, vitamin B6, vitamin B12 and folic acid. In support of its claims, the advertiser offered the expert opinion of Dr. Jay Udani, board certified Internist and current CEO of Medicus Research, a contract research organization for that tests products including botanical drugs, dietary supplements and functional foods.

The Udani report contained the expert’s opinion on whether the advertiser’s claims were substantiated by the current body of scientific evidence. The expert also appended the relevant studies to the report.

NAD noted that the evidence in the record consisted primarily of studies of the efficacy of the individual ingredients in Statinzyme. Because the studies were either not a good fit for the advertiser’s claims due to differences in dosages and formulations or the results simply did not support the challenged claims, NAD recommended the advertiser modify or discontinue all claims and testimonials, including:

  •  “If you want to help relieve and stop muscle pain fast, you can now do so with Statinzyme (The Ultimate Supplement To Your Cholesterol Lowering Medication).”
  •  “CoQ10 is important for the health and function of our muscles, and low levels of CoQ10 have been shown to cause muscle pain and weakness.”
  •  “A large clinical study (n>18,000) proved that the addition of fish oil to the statin regimen resulted in a statistically significant 19% reduction in the risk for major coronary events, defined as sudden cardiac death, fatal or non fatal myocardial infarction, unstable angina, or the need for revascularization.”
  •  “ “The vitamin D3 in Statinzyme may reduce cardiovascular risk in patients who are suffering from statin induced vitamin D deficiency.”
  •  “GLA [gamma linolenic acid] has been shown to improve statin induced peripheral neuropathies.”
  •  “Studies show that concomitant use of statins and resveratrol induces cardioprotection against myocardial infarction.”
  •  “The combination of B6, B12, & Folic acid is specifically used to reduce levels of Homocysteine which has been linked to increased incidence of thrombosis and cardiovascular disease.”
  •  “Studies prove that patients supplemented with B6, B12, and folic acid to reduce Homocysteine levels had a significant 25% reduction in strokes.”
  •  “… I need to take statins because my doctor told me that it would help me live longer. I started taking Statinzyme when I heard about it from my pharmacist. I was feeling very sluggish and my muscles were always aching…but thankfully that all went away after I started taking Statinzyme. I have more energy and my muscles have stopped aching me for over 6 months now. My pharmacist is a genius.” – Captain Ed. Age 56.

The company, in its advertiser’s statement, said that while it ”disagrees with NAD’s conclusions, in the spirit of self-regulation, we will take NAD’s recommendations into account in future advertising.”