Comment posted on FTC Director Vladeck – Consumer Protection Director in a “target rich environment” by David A. Mark

As a science consultant to the supplement and functional food industries I often trot out a parable for prospective clients “Don’t go camping in the woods, because of the bears. If you must go into the woods, don’t carry food with you. If you must carry food, don’t be the slowest camper.”

The FTC has made clear that companies depending solely on testimonials to market products are the slowest campers. Other likely targets are companies depending on “vampire science” – research gleaned from the published scientific literature but not replicated with their own product, the flaw being that the tested and marketed products are not equivalent in chemical composition or quantity.

Recent comments by David A. Mark

• FTC takes snap, crackle out of Kellogg cereal health claims
  Nice post, as it confirms the FDA and FTC are policing hard on claims for cognitive or immune benefits, especially those directed to parents of young children.

  Another shoe may drop soon. The fourth International Conference on Polyphenols and Health, held in the UK in December 2009, saw many experts on this topic stating that many, perhaps all, of the health functions of polyphenols have nothing to do with antioxidant activity. If the FDA and FTC come to agree with this building consensus, many of the current label and marketing claims will be challenged.

• FDA Finally Getting Tough on False Food Claims
  The 17 Warning Letters that were dated Feb 22 but made publiic March 3 were more of a shot through the engine room than a shot across the bows. Nestle alone got Warned on four products, and is most likely overhauling every label it sells. POM took a direct hit, as did walnuts, which has an FDA-approved health claim and still managed to go over the line!

  What I found interesting is that the targets were all food companies. Usually the supplement industry takes a few hits when a shotgun blast like this goes off. We will have to wait to see if the FDA’s aim continues to be foods, or if supplements will get their turn.

• What marketing draws the ire of the FDA?
  I will add a lesson #4: The FDA will act fast when it wants to. Normal practice in Warning Letters is to require a response in 15 days. In the Letters that went to H1N1 product manufacturers they were allowed 48 hours to reply.
• Good news, bad news and more bad news on vitamins
  Item #3 was more complicated than that. It was done in Norway, 70% either current smokers or former smokers, and combined folic acid at 800 ug/d with vitamin B12 at 400 ug/day. The study saw an uptick in all cancer but that was mostly due to lung cancer and not colorectal cancer; earlier studies had seen upticks in colorectal, breast and prostate cancer, but no mention of lung. Within the JAMA study the authors note that all got the same doses, but only those that responded with a high serum folate were at higher risk. And then, two days after the JAMA article, a different study by Wu et al in AJCN reported a trend for lower recurrence of adenoma after years of folic acid at 1000 ug/d, with a better response in the subset that had started with low serum folate. Clearly, the consequences of folic acid fortification and supplement taking are confusing, complex, and likely involve a genetic component.
• Vitamin D at 5,000 IU: Too high, or just too soon?
  I am the original blogger. The key question is not what happens to serum vitamin D as intake increases; rather, it is clinical consequences. And benefits and risks can coexist at the same intake. Admittedly, the hypercalcemia study
  referred to in the 1997 UL determination for vitamin D was conducted in 1984. Hathcock [Am J Clin Nutr 2007;85:6-18] more recently admirably reviewed the literature and recommended a UL of 10,000 IU/day. I personally expect the IOM report in 2010 will raise the Adequate Intake to 1000 IU but be more conservative in raising the UL from the current 2000 IU, if at all. Maybe to 3000 IU. The suspected risks include renal stones and calcification of arteries and other soft tissues. Regardless, the point of the blog was that right now 5000 IU products are “outside the pale” and subject to regulatory warnings.

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