New Regulations on Supplements (doctor, ingredients, diet, gain)

[Niners fan]

Most of the public is not aware of the new regulations that have come out recently on dietary supplements. Last summer, FDA released a set of Good Manufacturing Practices (GMP) for health foods. FDA took years crafting the GMP and for the most part they are pretty balanced in protecting the consumer and holding manufacturers accountable. The regulations take effect in 1-3 years, depending on the size of the company.

However, one aspect of the GMP stands to severely reduce the choices of the consumer. The GMP require that all batches (or a statistical subset thereof) of finished products be tested to prove that the product matches its supplement facts panel. The intention is good. But practically speaking consumers could see the price of many Multi-Vitamin products rise by $10-12 per bottle or more.

I would rather have seen FDA allow those manufacturers who have no history of fraudulent products to prove the supplement facts panel is correct based on batch records documenting input rather than expensive lab tests.

In 1994, Congress loosened the regulations on supplements and that is why the industry has grown so much in the last 14 years, creating jobs and tax revenue along the way. It is unfortunate that some people in DC see a prosperous industry as a ripe target for more regulation.

Just thought I would pass this on. This was a big deal in the industry but received no media coverage. I suppose it might when consumers realize what it is going to mean. The biggest impact will begin in Summer 2010 when companies with 20-499 employees have to begin complying.


I can't imagine that anyone who isn't already aware of this would actually want to read the final rule but here is the link to FDA's site:

Federal Register - 72 FR 34751 June 25, 2007: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Final Rule (http://www.cfsan.fda.gov/%7Elrd/fr07625a.html - broken link)

[PinkString]

I have heard from other sources that the FDA which is closely linked with big Pharma is really trying to reduce our choices in supplements, make us pay a lot more! And try to get us to give up in frustration and see doctors and take crappy medications instead. What they don't realize is we will find a way to get our supplements and nothing will stop us! This just ticks me off. We need our health freedom!
I refuse to be a sheeple. Baaaad baaaad..lol

[eddiek]

The FDA is trying to make manufacturers prove the worthiness and safety of these supplements which they do not do at the present time. In all too many cases, these unregulated items are touted as being far more beneficial than they truly are, and there is little to no clinical data to back the claims. Additionally, unlike regulated drugs, they are not tested for interactions or adverse effects in many instances. There has always been a controversy as to the effectiveness and safety of these drugs.

[Niners fan]

There is something to what both of you say. The Supplement GMP were developed based, in part, on the Drug GMP. The problem is that most drugs have one or two active ingredients to test. Many supplements have 6 or 8 or more ingredients to test. Plus the batch sizes are smaller for most supplements. So effectively you are spreading a larger cost over fewer bottles.

FDA has a definite medical bias. There are people who think that FDA is trying to basically outlaw supplements. I kind of doubt that. I think it is more likely that Pharmaceutical companies are lobbying for regulations that will make it so that they are more competitive than most current supplement companies. The Pharmaceutical companies already have much of the expensive lab equipment and have a larger marketing reach. These new regulations could especially hurt the mom and pop health food stores around the country.

Senator Dick Durbin (D-Ill) is pushing for pre-market testing of supplements, including those that have been taking for hundreds or thousands of years without major incidents. In my mind, his push is just one more step towards merging Supplements and Drugs. Here is the statement on his own website:

Durbin Statement on Good Manufacturing Practices for Dietary Supplement Makers (6-22-2007) (http://durbin.senate.gov/record.cfm?id=277662 - broken link)

I have confidence that the American consumer will rise up against Congress and FDA if they feel like their supplements are being taken away. After all, with the changes in the law in 1994 Congress had a larger response from voters than on any other issue since the Vietnam War. What concerns me are the changes that take place without media coverage so the Public is not aware of them. There is nothing that Big Government hates more than the light of public scrutiny!