Public health and the FDA and supplement regulation....

Today's Post: Monday, 8-15-2011

Eight days ago on Thursday, 8-4-2011, we did a post explaining that for knowledgeable doctors and consumers many supplements as they now exist are an important, often effective, and safe way to protect the health of the people who take them.

Not eating or drinking harmful things, and eating and drinking foods and drinks that do support or protect health, and getting regular exercise each week are still very important – and effective. Far too few people do this set of things yet though that is changing.

But as supplements now exist, you can do more than just those methods to protect your health by taking supplements or taking supplements too. And, though supplements do cost money, they cost dramatically less than drugs.

Removing most of them from public availability and making the ones left available cost as much as drugs -- as the current NDI proposal would do -- would harm the health of the people who now take them and avoid getting sick because of it.

Because of this, if the FDA were to adopt this NDI proposal as a policy and enforce it, two very bad results would happen.

The FDA would spend a lot of money to do so a time we are trying to cut unneeded spending. They would have fewer resources to protect the public health in ways that are actually needed. And, since with exceptions we note shortly, supplements are safe enough that this proposed policy would be an irresponsible waste of money.

But of even greater importance, many of the hundreds of thousands of people who are now using supplements to stay well would begin to get sick or do so years earlier.

This specifically means that if the FDA were to adopt this NDI policy it would seriously harm the public health.

And, since medical care costs have already risen so high it is acting as a drag on our economy when we need the economy to do better and add jobs, the added medical care costs this policy would create -- would be a disaster for the economy.

This means the proposal is so horribly bad, it calls into question the FDA as it currently operates being the right agency to oversee supplements at all.

And, since such a policy would increase the money spent on drugs when the people got these diseases and the FDA as it exists now gets significant funding from drug company fees, it also looks as if this proposal is proof that the inherent conflict of interest is such that indeed, the FDA as it exists now may well not be capable of doing the job of regulating supplements at all.

But, that said, aren’t there some real problems with supplements that some part of the government should regulate?

Yes. But reasonable proposals to do so or to do so more effectively are not the current FDA proposal.

My understanding is that the FDA has the authority now with no new policies needed to do more than they have in this area.

There are two problem areas that cause most of the problems.

1. People who take supplements take a regular amount on purpose usually every day. They control how much they get of each supplement.

But for many supplements taking way too much by mistake is not wise.

This happened recently with the drug ibuprofen where people took it straight as Tylenol and also took less controlled amounts in over the counter remedies they often didn’t know contained it. Since few people knew or know now that this drug can cause quite serious liver damage if taken in excess or more than tiny amounts on occasion if taken by people who drink alcohol regularly, this did cause quite serious harm.

Supplements are simply not that dangerous. But there are some that it’s unwise to take in massive excess this way without knowing it.

Melatonin is a supplement that is an effective and safe sleep aid for many people. But the effective amount is tiny. Half a mg a day or at most 1 or 2 mg a day is enough. People who take way more than that, don’t sleep walk into dangerous situations as people do who take many sleep inducing drugs. But people taking 5 or 10 or more mg a day of melatonin can be so mellow and laid back and groggy, they won’t function well at school or work or feel like they can wake up 100 percent the next day.

And, some people eat a lot of brownies when they are stressed or hungry.

So, putting a good bit of melatonin into brownies sold AS FOOD is clearly an idiotic and irresponsible idea.

Should the FDA or the supplement regulating part of the Department of health pull such foods from the market and prohibit them from further sales.

Absolutely they should. It was because some fools did exactly that that some people asked the FDA to do more. In this specific case, they were absolutely correct to do so.

This also suggests that many “enriched” foods and energy drinks also should be far more closely regulated than they are now.

This is not because the supplements in them are harmful if used right; but because the amount of the supplement people get when it’s in foods or drinks can be out of control and excessive.

2. The other potentially harmful area for supplements comes from supplements advertised to help cause weight loss or muscle building or restore the sexual capacity of older people.

a) Some weight loss supplements with many ingredients have been known to include real drugs unlisted on the label. Many stimulant drugs do decrease appetite and increase activity. So people taking them can lose weight without doing many of the things that take effort to do such as pass on fattening foods or soft drinks or get regular exercise.

But taking these drugs without knowing it or taking too much without knowing it can cause sudden heart failure or other serious or deadly problems.

b) Some supplements to build muscle contain anabolic steroid drugs not announced on the label. These drugs do cause muscle development. For some medical uses, they can be valuable but only if used with great care and control including only taking them for short enough periods of time.

Taking these anabolic steroid drugs without knowing it or taking too much without knowing it can cause serious problems here too.

c) Some drugs for sexual enhancement contain Viagra or other similar drugs that are not listed on the label. This can cause some embarrassing problems but it can also cause harm. Though these drugs do work, they do NOT remove the diabetes or artery plaque that often causes the need for their use. When you need to use them for physical reasons instead of mental ones, you often have conditions your doctor should know about! That’s why these drugs should need a prescription to get. Further, the kinds of companies who sell them without a prescription or hidden in supplements may use too much or include dangerous impurities not safe to take.

The FDA or the part of the Department of health that replaces it to regulate supplements AND the responsible companies in the supplement industry need to work together to remove these hidden drugs from the market when they show up and do so well enough to deter it in the future.

Note though, that the supplements that do help these conditions, that are disclosed, and are safe to take do not need to be removed or treated as drugs to do so.

The FDA long ago should have begun working with the supplement industry to find and remove these products with hidden drugs and the companies selling them from the market.

So these two parts of the supplement industry do need more regulation and more effective regulation.

But the current FDA NDI proposal would cause massive increases in cost for the FDA and medical care costs for the people who now protect their health with supplements and harm the public health and remove people’s right to choose by treating all supplements is drugs is NOT the solution needed to fix these two legitimate problems.

It’s about as useful as blowing up the building with people in it to get rid of a fly instead swatting it instead.