Zarbee's busted by FDA for dietary supplement claims

Zarbee's busted by FDA for dietary supplement claims

The Dietary Supplement Heath and Education Act of 1994 essentially removed dietary supplements from pre-market regulation by the FDA.  According to federal law, a dietary supplement is 

  • a vitamin or mineral; 
  • an herb or other botanical; 
  • an amino acid; 
  • a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or 
  • a concentrate, a metabolite, a constituent, or an extract.

Based on the largely unproven claim that taking these substances can improve health, Americans down them to the tune of $30 billion a year (2011).

Dietary supplements can't make the same sort of claims about effectiveness that prescription drugs can. Supplements cannot explicitly or implicitly claim to prevent, treat, mitigate, cure, or diagnose a disease. That is solely within the jurisdiction of prescription drugs, which are subject to extensive pre- and post-market regulation by the FDA. Instead, supplements generally have to stick to claims that taking them improves the body's "structure" or "function" or contributes to general "well being."  Trouble is, no one seems to know exactly what that means, including the FDA.  Here's what the Office of Inspector General of the Department of Health and Human Services had to say on the subject in a 2012 report:

a supplement may claim that it “curbs appetite to help with weight loss,” but it may not claim to “aid weight loss to treat obesity” because obesity is a disease. Similarly, a supplement may claim to “support immunity,” but may not claim to “boost the immune system against colds and flu” because the latter references specific diseases. Although FDA has issued regulations and published guidance describing the difference between structure/function claims and disease claims, it acknowledges the challenge of distinguishing between the two.

Of course, this distinction is often meaningless to a consumer.  Ms. Consumer wants to loose weight  whether she is obese or not and if a supplement claims it helps her lose weight she'll buy it.  Mr. Consumer wants to "support immunity" (whatever that means) even if he doesn't have a cold or the flu.  He'll buy the supplement either way.   And these purchases will be made even if there is no good evidence that the supplement curbs appetite, helps with weight loss, or supports immunity.  That's because supplements manufacturers are supposed to have some evidence of effectiveness but they don't have to give that evidence to the FDA for pre-market review.  

The (underfunded by Congress) FDA occasionally nabs a company for getting into prescription drug territory. Last month, a supplement company called Zarbee's became the target in one of these cases. According to its website, Zarbee's products were created by a pediatrician who is the father of four boys.  It sells only a few products and actually seems tame compared some of the supplement pushers, like GNC, for example. 

Zarbee's got a warning letter from the FDA telling it to knock off with the disease claims, which included:

  • Natural Ivy Leaf extract "helps thin and loosen web mucus coughs"
  • dark honey (a supplement ingredient) is "clinically proven to calm coughs and sore throats in children"

Social media got them in trouble too.  Zarbee's "liked" some testimonials posted by customers on its Facebook page.  (I must digress:  The internet provides so many more opportunities than in pre-internet times to get in trouble, doesn't it?  Plus the benefit of a record of what you've done that never goes away.)  A sampling of "liked" comments:

  • Zarbee's Children's Sleep Remedy helped relieve insomnia of daughter on ADHD medication and another child with cerebral palsy.
  • A customer had been "battling either bronchitis or pneumonia for the last 18 days" found Zarbee's Children's Cough Syrup got rid of hoarseness and made her throat and chest "feel better."
  • Parents report that Zarbee's is the only medicine they use for their 2 year old.  [Yikes!] "Colds and congestion clear up in 2 days."
  • A poster's husband was "very impressed" by the way Zarbee's allergy relief "worked for him."

["Yikes!" added by author.]  Of course, it is entirely possible that these products contain some active ingredient that improved symptoms or affected the course of disease. It is also entirely possible that these results were due to the placebo effect or the natural course of the disease. That's the problem with supplements -- without clinical trials, you can't know. ff Zarbee's is going to make claims that their products accomplish these things, they have to jump through the considerable hoops that drugs must clear before getting to market. The FDA also noted that Zarbee's cough syrup + mucus relief, nighttime cough syrup and sleep remedy "are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners."

Unfortunately, in this as in all dietary supplement claims, the FDA can only play catch-up.  It has no authority to vet claims before they appear on the market.  In any reasonable system, dietary supplements would be treated the same as drugs (either OTC or prescription, depending on the circumstances) because that is essentially what they are.  Zarbee's will have a chance to respond to the FDA's warning letter, after which it can work out a settlement with the FDA or, if the parties can't come to an agreemeent, the FDA can proceed with an enforcement action and the whole matter can be tied up in administrative proceedings and court for several years.  











Points of Interest 7/12/2014
None so blind