Why supplements are worth saving as they currently exist....

Today's Post: Thursday, 8-4-2011

There are a number of ways people can actively support and improve their health.

1. They can learn what NOT to do and why and choose to NOT do those things.

Examples are not smoking, avoiding second hand smoke, not eating packaged snacks and desserts, not eating foods with hydrogenated oils or high fructose corn syrup, and not drinking soft drinks.

2. They can eat in ways that have been shown to help people stay healthy and eat more of the things that are unusually nutritious or health giving or help keep excess fat off.

Examples are eating beans and lentils, using only extra virgin olive oil instead of oils high in omega 6 oils or saturated fats from grain fed cows, and eating “superfoods” such as organic blueberries, broccoli florets, and more.

Three diets fit this well: The DASH II diet with extra virgin olive oil added, the Mediterranean diet with less pasta and more vegetables, or the paleo diet plus beans and lentils, extra virgin olive oil, and some dairy -- either low fat from grain fed cows or from cows fed only grass.

3. They can get all 3 basic kinds of exercise every week to the best of their ability and keep doing so as a lifestyle choice and upgrade. These include strength training, interval cardio, and different kinds of moderate exercise such as tai chi and walking.

4. And, in almost every specific area of health or health concerns, there are specific supplements available today to help people become healthier or prevent disease.

The evidence is clear for a very large number of specific supplements that they can be effective and in some uses even life saving.

The supplement industry is not perfect. But given that, the track record over the last 20 years for the whole industry has produced far less problems for people taking the supplements than aspirin all by itself. This includes the few supplements that have been problematic.

In addition, when consumers learn that certain supplements can be harmful they stop taking them. Ephedra caused some problems and few people take it now because those problems were publicized.

Because supplements contain folk remedies used for hundreds of years in many cases or are based on food ingredients from superfoods or spices and compounds natural to the human body, they have several benefits.

This makes them quite safe and explains why there are so few problems with them.

They quite often contain multiple ingredients that support health, sometimes even producing the desired result by containing mutually helpful ingredients that produce better results than using only the ingredient most helpful by itself.

They have very few side effects. This means that unlike many drugs, they can be taken without the side effects that, in drugs, often provide a specific needed benefit but harm the quality of life or even the health of the people taking them in other ways.

In addition, they often help fix the causes of illness instead of just removing the symptoms as drugs sometimes do.

This set of tools for good health overall contains supplements that are effective in helping people stay healthy in almost every important area of health.

Some are very inexpensive and some are a bit pricey. But because they are NOT treated as drugs, which their safety record does not justify, they are often dramatically less expensive than drugs addressing the same conditions.

There are people with a family history of heart disease who have very low risk factors for heart disease by doing the first 3 things AND taking the right supplements now have very low risks. I am such a person. And I have the blood tests to prove it.

In almost every area of health there are now people like me who are healthy now at reasonable cost because they do the first 3 things and take the right supplements.

This means that removing supplements from sale that have proven safe and preventing new ones from being developed would severely harm thousands and thousands of people. People who stay healthy now would get sick or they would develop diseases decade earlier.

So, it would strike a grave and serious blow to the public health of people in the United States.

But that’s far from all. The medical care costs that this would generate or make happen decades earlier than they would now, would be added to the massive cost increases of health care.

Those new costs would devastate our economy. Since it already is in serious trouble from the already high health care costs and other reasons, this is even more undesirable!

How you feel if you were forced to use only the computers and software that were available in 1994 and any upgrades would be few and cost thousands of dollars each?

This is exactly what the FDA has just proposed for supplements. All supplements now in use with a good safety track record but introduced since 1994 and any new supplements would become considered as and be tested as drugs.

This shows a complete misunderstanding of what supplements are and their current value to the public health and our economy.

Reasonable requirements would be that the providing company:

Have its supplements tested at independent labs after purchased by the lab from a current retailer to show the supplement listed contains the supplement and the amount of it that is on the label and does not also contain impurities or drugs not on the label and include that with the notice to the FDA.

Then the NDI notice would be automatically approved when the FDA takes delivery of the registered letter with this information. There would be no months or years long delay for supplements already in use to be approved or massive costs needed. Only if the supplement failed the tests would more be needed.

(As I understand it, the FDA already has the power to acquire any safety problems reported with the use of specific supplements and already collects this data. So any problems in use can be addressed later for specific supplements.)

As I see it, unless the FDA completely re-writes their current proposal to avoid treating supplements like drugs in ways similar to what I’ve just proposed, the FDA as now constituted should not be in the business of regulating supplements.

This quite possibly will prove to be the case. There is an inherent conflict of interest involved. Much of the FDA’s income is from the work they do regulating the pharmaceutical industry.

But if the FDA consults with the supplement industry and only plans to add reasonable requests such as those I’ve outlined above, then perhaps it can rise above this conflict of interest.

If it does not, we need a new and separate regulatory entity entirely. Or perhaps the FDA should be divided into 3 completely independent parts. One for food. One for drugs and medical devices only. And one for supplements.

Disclosure: I have a personal interest in this. My Dad died of congestive heart failure after surviving 3 heart attacks but having his heart damaged by them.

As a result of doing all four of these things, I dropped my LDL from the over 160 common in the rest of my family to 130 and then to 73 by adding supplements.

The sterol supplements I take that have produced a significant part of the 57 point drop in my LDL cholesterol would disappear from the market under these new FDA proposed guidelines. Then if they returned after a delay of a year or two, they would cost $80 a bottle or more instead of $8 that I pay now. Since sterol supplements have been in use for over 10 years with a superb safety record, this is not at all in my interest or in the interest of the thousands of people like me.

5. Drugs and surgery and medical devices and procedures when use precisely after the individual patient’s exact needs are determined can be very valuable and lifesaving when things go wrong.

But they are dangerous if misused or overused or used on the wrong people or on people who do not need them.

For those who stay healthy, they are not needed except for accidents and communicable diseases.

And, because drugs and surgery and medical devices and procedures have serious risks and side effects they should only be used sparingly and when truly needed.

This will be most doable in years to come only when people do more of the first four things here than most do now.

Removing supplements would make this even less possible. It clearly moves things in the wrong direction.

If you can, write the FDA. In finding out about this proposal, I got a suggested letter to write to them on this subject. (Since the deadline for public comment is quite soon, do it as soon as you can because if you delay a few weeks from here you will be too late.)

I’ve included it here for any of you who would like to use its wording.

It has the address to mail it to.

If you do that, also feel free to include a copy of this post. (I’ve made my best effort to explain WHY these proposed guidelines are unneeded and would go against the public interest and harm the overall economy not just the supplement industry.)

Food and Drug Administration
Division of Dockets Management (HFA-305)
5630 Fishers Lane, Room 1061
Rockville, Maryland 20852

Re: Draft FDA Guidance Document for NDIs; Docket # 2011-D-0376-001

Dear Sir or Madam,
I am writing you to express my grave concerns about your Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient (NDI) Notifications and Related Issues, which was issued for industry and other comment in early July 2011. Your Agency sprung this on both industry and consumers without seeking any prior input from either and your draft Guidance is badly flawed as a result. Therefore, I ask that you withdraw this document at once, consult with industry and consumers on a longer-term basis than the 90-day period, and come out with a new Guidance that better reflects the realities of the marketplace and the safe track record of supplements, including those with new dietary ingredients (NDIs).
In particular, this draft Guidance causes me concern because it:

Requires NDIs to meet drug-like safety tests
Requires NDIs to be proven through unnecessary, expensive tests
Elevates NDI submissions to food-additive or GRAS levels

Ignores the incredible, proven safety record of supplements, both new and old

Ignores the intent of Congress when passing DSHEA that "the Federal Government should not take any actions to impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers"
Through its imposition of unnecessary high costs, arbitrarily discriminates against small- and medium-sized businesses
Will put thousands of people out of work by destroying jobs in a time of economic decline
Turns a basic notification system for new supplements into an arbitrary approval system.


Is overly burdensome and destructive of Congress' express intent in DSHEA that "the right of access of consumers to safe dietary supplements is necessary in order to promote wellness."