FDA & regulating foods and supplements….

Today's Post, Friday, 5-15-2009

I have seen two things in just the last few days on this issue.

One suggests the FDA is not quite bright or well informed on this issue.

The other is a legitimate looking argument for the FDA to be able to regulate supplements as if they were drugs. It does suggest a legitimate role for the FDA but does NOT show that regulating supplements as if they are drugs is at all wise. That is in fact demonstrably incorrect.

Given the knowledge of the FDA of the legitimate health effects of foods and supplements, as revealed by its actions at least, the FDA is simply not up to the job of regulating health claims.

And, since there are an extremely large number of foods and supplements that do strongly support health and prevent disease, it would cause massive harm to the health of many people if the FDA had the power to regulate supplements as if they were drugs.

However, the legitimate looking argument for the FDA to be able to regulate supplements might suggest a compromise position that WOULD benefit the public health without harming it.

1. Here’s the recent news item that suggests the FDA has an incompetent understanding of how to regulate health claims about food and should NOT at its current level of competence be given more power to do so.

They said that the General Mills cereal Cheerios must stop claiming that their cereal helps prevent heart disease. And, they said that in order to make that claim, General Mills would have to have this fact tested as if the food was a new drug to prevent heart disease.

To me this virtually proves the FDA in its current form is not up to the job of regulating health claims for food & should NOT be trusted to do so.

a) Cheerios probably does more to create than prevent heart disease. So, even if they don’t know why, and I doubt they do, the FDA likely may have had a good idea in asking General Mills to stop making that claim about Cheerios. (If the FDA DID know why Cheerios probably does more to create than prevent heart disease they could have done a LOT more good at dramatically lower cost by releasing that info as a very well publicized press release. They did not include that info, so I seriously doubt they know it.)

Although it’s old, and we now know dangerously incomplete data, very high total cholesterol readings to tend to indicate a greater risk of heart disease and high levels of LDL cholesterol even more so. Eating oats does tend to lower total cholesterol and LDL cholesterol because of the soluble fiber in it. So, since Cheerios do have some oats and soluble fiber, the FDA might have researched the issue and required General Mills to say something like this on the Cheerios box.:

“Eating Cheerios may help some people prevent heart disease.

Cheerios has some soluble fiber from oats that can help lower LDL and total cholesterol somewhat for some people who eat it. Studies have found that lowering LDL and total cholesterol if they are high can help prevent heart disease. However, there are many other factors that influence heart disease, some even more strongly than LDL and total cholesterol. So eating Cheerios may or may not help prevent heart disease for any given individual.”

Each of these statements are careful and truthful. They make the case for Cheerios without hype that might lead a consumer to assume eating Cheerios is more beneficial than it actually is.

Had the FDA required General Mills to make that claim instead of the one they do now and issued a separate press release noting there are aspects of eating Cheerios that are NOT conducive to reduced heart attack risk, then I would think differently. But the FDA does not currently operate that way, so I don’t think they are up to the job and cannot be trusted to do it.

b) (The press release the FDA could easily have issued could have said that as a high glycemic cereal, eating Cheerios also tends to increase triglycerides and blood sugar levels and contribute to obesity. And since obesity also tends to induce high blood pressure while high triglycerides, high blood sugar, and high blood sugar all tend to CAUSE heart disease, many customers would do themselves and their heart health harm by eating Cheerios.)

Here’s why saying that a health claim for a food should require the kind of massive and expensive testing that drugs do would be quite harmful.

Some foods DO have health benefits with repeated research studies already published showing that they do. If people who sell those foods cannot say so that’s wrong two ways. It infringes on the right to free speech. (If a government agency can require you not to publish the truth, there is no free speech.) But it also harms the public health by withholding information that would enable them to better protect their health.

And, no food company can afford to have that kind of testing done, so saying they can only tell the truth in public if they do that testing is total incompetence on the FDA’s part and harms the public health the FDA is supposed to be helping to improve.

Since the actions of the FDA strongly suggest they don’t get that at all, I say they are not up to the job and should NOT be trusted with it.

2. The situation with supplements is quite similar. But there is one legitimate problem with supplements the FDA likely should be able to handle that would enhance the public health if the FDA had that job while NOT having the job of policing health claims for the supplements OR requiring them to be tested as drugs.

Can the FDA safely be given that limited job? If so, it might be a good idea.

Here’s one part of that legitimate problem.:

In the Medscape medical email I get I recently found this:

“FDA to regulate dietary supplements

Posted By: Bruno Oliveira, Rheumatology, 12:31PM May 1, 2009

From The Rheumatology News Journal (Rheumatologynews.com)

The Government Accountability Office (GAO) released a report (http://www.gao.gov/new.items/d09250.pdf) in January of 2009 titled: "FDA Should Take Further Actions to Improve Oversight and Consumer Understanding." This document outlines the current state of affairs in which the FDA has little power, if any, over companies that produce dietary supplements. Even if the FDA finds a product to be harmful, they can only ask for a voluntary recall.

Ten glucosamine products were tested and four of them didn’t have any glucosamine. Only two in the remaining six products had the advertised amount of glucosamine.

Do you agree with the recommendation to increase oversight to solve this issue?

Do you think the complementary and alternative medicine (CAM) industry should be regulated as regular medications/devices are?”

In the first part of this post, we show that the FDA should NOT be given the authority to regulate health claims for food or to regulate foods for which health claims or information exist as if they were drugs.

So there is no way I think the public would benefit if the FDA was given that right. In fact, I believe strongly the public health would suffer greatly if that were to happen.

For example, I’ve moved my own heart health indicators, by actual tests, into a very healthful range using supplements only. If the FDA were to make those supplements unavailable or cost six times as much or both my heart health and heart protection would drop like a stone.

And I’m far from being the only person for whom that’s true. This is evidence based and verifiable. But if the FDA regulated those supplement as if they were drugs, I would be deprived of them totally.

I’d prefer to be able to act to protect my health. If the FDA were to prevent me from doing so, which it WOULD do by regulating these supplements as if they were drugs, they would harm the public health. So I think they should continue to be denied that right.

However, what DOES look like a legitimate role for the FDA is shown quite clearly in the piece above that I found on Medscape.

Why not give the FDA the right to enforce that a supplement must have the ingredients stated on its label?

Similarly, some supplements have been found to contain actual drugs but with no listing on the label saying so to enable someone who should avoid those drugs to do so. And some supplements have been found to contain contaminants such as lead or bacteria that harm health.

I think the FDA should be able to enforce that a supplement have NO ingredient not listed on its label, including any and all undisclosed drugs. And I think they should be able to ban supplements that contain harmful contaminants.

So my conclusion is that to be sure that supplements are safe to take and contain what they say they do and only what they say they do, it might make sense to give the FDA that role but that role ONLY.