Tuesday, April 26, 2005

Comments regarding my post on FDA and nutritional supplement regulations

In response to my post yesterday on the FDA and nutritional supplements, Fred refers us to a column by republican congressman Dr. Ron Paul. Congressman Paul is properly concerned with the impact of government intervention on consumer choice and presumably was cited because Fred feels the same way.

Perhaps we can reach some common ground. Would you be willing to accept that government has an overriding interest in insuring that:
  • Any nutritional supplements on the market are at least be proven to be safe for consumption and are at least not deleterious.

  • Such supplements are marketed only with claims that have been validated on the basis of medical data i.e. that the packaging reflects supportable claims.

  • Such supplements meet standards with regards to claims of purity, strength, etc.
Government regulations such as these would allow companies to market any supplement they can prove is safe as long as the label accurately reflects what's in it and that no unproven claims are made with regards to efficacy.

It seems to me that this kind of legislation might strike a happy medium of government's overriding interest in public safety and the consumer's right to choose what goes into their bodies. Or do you believe that no government intervention is warranted as far as nutritional supplements are concerned?

Yes? No?



Blogger Fred Mangels said...

Not sure just how much I would agree with your proposed criteria. I do have a problem with any person or business having to jump through hoops just to market a product.

If someone wants to sell me something, it should be my choice whether to buy it whether the government deems it safe, or not. Sure, I like disclosure but who keeps an eye on the guys enforcing the disclosure?

If the supplement industry wanted to start their own trade group to establish standards and certify products as meeting their criteria, they should be free to do so but that doesn't mean that all companies within that industry be forced to join that group or abide by their standards. Not sure if I would accept mandatory disclosure of certification on labels or packaging either. If someone wants to offer a product, and simply label it "Gingseng, 100mg", let them have at it. Myself or others may not buy the product, though, since we may want to have more info available before making a purchase. Others may not care and may prefer whatever benefit THEY feel the product offers, regardless of the information or certification.

Remember too that there are Underwriter's Lab type outfits around that test all kinds of consumer goods. I someone found out a company was selling parsley in capsules claiming it was Golden Seal, they could not only face public humiliation but civil and criminal fines as well.

Would an industry group be akin to the fox guarding the henhouse? Yes, it could well be, but that's not to say the same might be true of the FDA, at least according what people say in some circles.

But, I might go along with the FDA idea, despite what shortcomings there may be, if it were voluntary. If some company wanted the FDA to certify the efficay of it's product, whether it be a supplement or drug, they could voluntarily submit it for certification. If a person or company decided it wasn't worth the hassle of submitting the drug to the FDA, let them try to market it without FDA approval.

I might well chose not to buy something, as mentioned above, if it didn't have certain certifications, whether from the FDA or a private group but let's let those people compete in the marketplace and see where it ends up.

Keep in mind that there is always civil recourse for fraud and the like, whether the wrong is real or imagined. Even FDA approval doesn't necessarily protect against civil suit. Remember some years ago when Medtronics was sued for some thousands of dollars for some heart pacemaker or implant device, I forget exactly what it was. To paraphrase the court: "Simply because the product was approved by the FDA, doesn't relieve the company of financial liability for a defective product...".

The idea that the FDA, or any other entity, should be there to assure us of quality in what we buy sounds good, but one wonders what the end result really is?

Just saw something this morning about the FDA condsidering (or did they actually do it?) pulling some drugs- Celebrex being one I remember- off the shelves for alleged adverse side effects. I've used Celebrex. It works quite well for me. Now they're saying I can't use it for risk of heart attack or stroke. Who should be deciding that question of what risks are acceptable: myself and my doctor or some politicians and bureaucrats? I prefer making the decisions myself.

Should the FDA be sued since they allowed Celebrex on the market in the first place? You won't see me filing suit and I suspect they're are immune to such lawsuits no matter how many mistakes they make.

April 27, 2005 9:29 AM  

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