Jon takes a look at the huge furor over a new bill called the “Dietary Supplement Safety Act” that has been introduced, what does it mean and why this is happening.
There is a theme running through Steven Spielberg’s last film, Catch Me If You Can, that basically says the New York Yankees won all their pennants not because they had better players, but because their opponents couldn’t take their eyes off the pinstripes in the Yankee uniforms. It’s a metaphor for what pickpockets do — bumping or confusing you with one hand, so you never notice that the other hand is picking you clean.
Alternative Health Community
Well, right now, I believe the alternative health community is focusing on pinstripes, while our right to purchase the supplements we want and need is being picked from our pockets – and no one is noticing.
Dietary Supplement Safety Act
Right now, there is a huge furor over a new bill called the “Dietary Supplement Safety Act” (S.722) that has been introduced in the U.S. Senate by Dick Durbin, the Democratic Senator from Illinois.
This is a very bad bill, and truly needs to be opposed. It would give the FDA broad sweeping regulatory power, require adverse event reporting by manufacturers, and would authorize the FDA to prevent the sale of any supplement for which even a single adverse event was reported. If passed, it would significantly undermine many of the freedoms that American consumers of dietary supplements hold dear.
Incidentally, according to this bill, the adverse event reporting and subsequent clinical evaluation don’t necessarily have to establish cause and effect, and the event itself could have been caused by consumer misuse. Nevertheless, once an incident was on file, the manufacturer could be made to go back and earn the FDA stamp of approval — a stamp that drug companies, incidentally, get up front. This process could take many supplements off the market indefinitely. Also, any new supplement containing a stimulant — including, for example, Chinese botanicals – would need FDA permission up front.
This bill is, of course, nonsense and unnecessary and would be a disaster if it were to pass. So why do I equate it to Yankee pinstripes? Because, the odds of this bill passing are close to zero. It is unlikely to pass for a number of reasons — the two main ones being.
- It is just too outrageous, and will galvanize the alternative health community into a storm of activity (which we’re already seeing) to make sure it is never passed
- The Republicans, notably under the guidance of Orrin Hatch, are likely to oppose it en masse
So if it never has a chance of passing, what’s the point of introducing it in the first place? I believe it is to keep us looking at pinstripes while our pockets are picked in an entirely different manner.
Even as the alternative health community mounts it’s counterattack to S.722, our rights to buy supplements that we want and need are already being taken away right under our noses — and no one ever even gets to vote on it.
Ephedra – Kava Kava – St. John’s Wort
Ephedra and kava kava and St. John’s wort are some of the most notable, but others are in the pipeline. The process is simple:
- A study is initiated — often backed by the pharmaceutical industry — to study the safety of a particular herb or supplement. (How kind of the pharmaceutical industry to fund herb safety studies. Such concern for public safety warms the heart, don’t you think?)
- The study finds some reason for concern — even though the study itself is seriously flawed and virtually useless. For example:
- The case against ephedra is based on statistical nonsense. The FDA compiled a list of people who died from heart attacks or strokes while using ephedra. Amazingly, they determined that 100% of the people on that list were people who had died using ephedra. Duh! Compile a list of all those who died from heart attack and stroke and drank water, and 100% of the people on that list would be water drinkers. Does that mean that water causes strokes and death? Only an idiot (or a Federal regulator) would believe that. The truth is that in studies comparing groups of people who use ephedra products with those who do not, there is virtually no difference in the rate of heart attacks and strokes! (Note: I am not a fan of ephedra because it exhausts the adrenal glands and do not use it any of my formulations — but nonsense is still nonsense.)
- The case against kava kava is equally bogus. I covered that in detail in the May 5th issue of the Baseline of Health® Newsletter. Again the case is based on statistical nonsense — but even though false, the “awareness of danger” is now out there.
- Once “awareness of danger” has been created (again, even though totally bogus), the insurance companies will no longer insure companies that manufacture or sell products that contain those “dangerous ingredients.” The insurance companies are very clear about this. They do not care if the case against the supplement is true or not. They only care if there is a “perception” that it is true. From their point of view, if there is a perception of danger, there is an increased risk of lawsuits.
- The net result is that manufactures and retailers start pulling products from the market to avoid losing their insurance and risk exposure from spurious lawsuits.
- Notice how much less ephedra is available in the market today. There are no real laws against it yet, but notice how many companies have stopped manufacturing and selling ephedra-based weight-loss products.
- Kava too has begun to fade from the market, but the effects are not as widely noticed yet because insurers grandfather companies in. That means that if a supplement company has a 3 or 5 year policy with its insurer that included kava before the concerns appeared, they will remain insured for the duration of the policy — but will not be renewed for kava when the policy comes up for renewal. We’re now about a year into the cycle (several years behind ephedra). That means that as each year goes by for the next 4 years, there will be fewer and fewer kava products available.
The bottom line is that this is far more insidious than S.722. At least with 722, you can face the enemy and fight back. With this procedure, you never get to see the enemy. You never get to hold your representatives accountable — because they never get to vote on the issue. Here, all it takes is the FDA deciding to target an herb, or a pharmaceutical company deciding that some supplement threatens one of its markets. Then the right study is commissioned, and before you know it, your ability to buy some herb or supplement has been removed without your ever knowing why.
And in the meantime, we all remain dazzled by the pinstripes of bills like 722 — bills that are unlikely ever to pass.
Oh, and if you live outside the US, don’t be too smug. Once the “perception of danger” exists offending supplements are quickly banned, no matter how bogus that perception may be. See what’s happening to kava kava and ephedra formulas in Canada or Europe.
The really disturbing thing is that I have no idea how to stop it. Bills like S.722 at least allow us to confront them and defeat them. But squeezing supplements off the market by pressuring insurance companies is incredibly nebulous. How do you confront it? How do you rally a public outcry against it like we’re seeing with S.722?
And yet, if we can’t find a coherent and effective strategy, we will one day wake and find that we have been picked clean of every supplement that actually works.
PS: In the meantime, we do need to act against 722. Call your Senators or send them a letter telling them to vote against SB 722. Although less effective, if nothing else, you can send them an email.