FDA issues new safety rules for vitamins

WASHINGTON - For the first time, manufacturers of vitamins, herbal pills and other dietary supplements will have to test all of their products' ingredients. The Food and Drug Administration said Friday it is phasing in a new rule that is designed to address concerns that existing regulations allowed supplements onto the market that were contaminated or didn't contain ingredients claimed on the label.

Last year, the agency found that some supplements contained undeclared active ingredients used in prescription drugs for erectile dysfunction. In the past, regulators found supplements that didn't contain the levels of Vitamin C or Vitamin A that were claimed.

If, upon inspection, the FDA finds that supplements do not contain the ingredients they claim, the agency would consider the products adulterated or misbranded. In minor cases, the agency could ask the manufacturer to remove an ingredient or revise its label. In more serious cases, it could seize the product, file a lawsuit or even seek criminal charges.

Dietary supplements — pills, liquids or other products — are a $22 billion industry.
http://news.yahoo.com/s/ap/20070622/ap_on_he_me/dietary_supplements

of the industry.

When it comes to herbal supplements, etc, the FDA wouldn't know shit if it stepped in it, put it on a kebob stick, tossed in on the grill with some Pat's Ho Made and ate it for dinner.

You do know that a great deal of herbs come from China, and we know how great their track record is with safety. Nothing wrong with saying that a vitamin should meet the same requirements that aspirin does.

Track records for safety are nothing short of a travesty when it comes to FDA midnight approvals.

A great deal of traditional medicine also comes from that part of the world, even though the ingredients don't. The FDA has banned more supplements with eons of proven track records simply because Big Pharma doesn't get a chunk.

We are talking about TRUTH IN LABELLING. Perhaps you prefer to have ethylene glycol in your toothpaste. Phen-fen had more to do with the actual testing and misuse of the meds than LABELLING. REGULATION IS A GOOD THING.
Unless you happen to be a Reagan Republican that is.

"Truth" is a word they really don't get.

I research my ingredients.

Fuck your "Reagan" reference. Regulation is fine if it's not done by Big Pharma's biggest on-the-knees supporter.

Its a actual working knowledge of how the SCIENTIFIC branch of the FDA works. Including using regs called Good Laboratory Practices, and Good Manufacturing Processes. Also I have been through SEVERAL FDA inspections and let me tell you something, they are difficult and companies that don't pass have real problems. Even companies that get warning letters often find themselves in deep financial straits if the science community believes they are having issues with the FDA. Do you know the history of the FDA, btw? It was set up to buffer agaisnt the kind of behavior you accuse it of. The regulations are firmly in place. Its the lack of inspectors and enforcement that is the issue. The rules for private industry are much stricter than even for the government. Also employees at FDA have what are called "conflict of interest" rules. No govt employee can own stock or have financial interest in Pharma/biotech companies. So even if someone once worked for a Pharma and Biotech (and thats very common, I myself have worked for both private and government agencies at one point..Pharmas are actually good to their employees so many biotech and scientific professionals will work and stay for a long time) there is nothing to be gained by illegally "helping" a company. Besides the scientific advisory committees are made up career MD's and PhD's from multiple sources. The FDA generally does listen to its advisory committees, when it doesn't thats when you know there is something fishy going on with the political heads of the FDA. Actually many in the science community feels like the FDA is overly cautious in approving new drugs. For every bad story you hear about there are 10 good new drugs approved and probably 15 that are rejected by the FDA.

Remember how that got passed? It's not science. It's money.

There's about 10 more life saving drugs being approved through the correct science by the FDA, that aren't publicized. the MSM loves to dwell on the bad stories In fact, I myself am the beneficiary of some of these meds made by HORRORS Merck of all people. The system isn't perfect but its much much better than most of the rest of the world. Read about the "regulations" in China sometimes and you will understand how superior our system is...

is a different issue -- under these guidelines issued by the FDA, the supplement version of Phen-fen would be allowed.

All this does is require that if you call a supplement "Willow bark" that it actually be willow bark, and that you don't use arsenic as a filler.

I can't see the downside to this.

is stuff that has had significant safety testing done that shows toxicological effects on humans and or animals. I have regulatory experience. There is YEARS of scientific study done on stuff that the FDA regulates. Its the unregulated stuff that hasn't been testing. I suggest you learn more about NIEHS' National Toxicology Program. It's the world's premiere study on chemical (and herbs and vitamins are CHEMICALS) safety. Most stuff submittted and banned has gone through 2-5 years of tox screens.

explain ephedra.

Have at it.

It is unsafe. And the safety testing proved it, along with the very notable deaths of young and healthy ATHELETES who were taking it. Have you ever tried the stuff? I was 100% healthy at the time and it gave me bad heart palpitations. Ephedra is a bad substance

and you have no science to back it up.

Ma huang has been used for HOW many years?

Irresponsible use, maybe. It's not unsafe. Notable deaths were supplemented with numerous variables.

Absolute bullshit.

It seems that its not the Ma huang thats the problem, but the addition of other chemicals with it and thats what caused the bad reactions it seemes and thats how it was being marketed in a totally unregulated way...it often was not as advertised causing trouble
http://ntp.niehs.nih.gov/index.cfm?objectid=E87F352F-BDB5-82F8-F07D41E8B443A532
Had the FDA had these new rules back then, perhaps Ephedra would not have been banned...

that it's not ephedra/ma huang, it's the usage?

So, like, if someone took 3 Ripped Fuel tabs and chased it with 3 Red Bulls and then went and exerted oneself in the hot Florida sun one might have issues?

Big shock. Read directions.

The people manufacturing it were putting UNLABELLED substances in it an this contaminating/adulterating it and thus making it dangerous. Apparantly it was a VERY common practice--which makes the whole ephedra thing and EXCELLENT reason why this truth in labelling law is important

a reasonable policy to me. It requires that supplements have what they say on the label, and that they're not contaminated.

x(

'bout time there was some regulation in the multi-billion dollar supplements industry.

Sid

protect us from Big Pharma and all the crap they pull? If the supplement industry is a multi-billion dollar industry I guess Big Pharma is a multi, multi billion dollar industry. It's great the way they wine and dine the doctors to get them to push their drugs. It would also be great if our food was safe. I guess I'm asking for too much.

that the FDA does keep off the market. The media does a real good job at ignoring that fact.
Many scientists believe that the FDA is too slow in approving some of the new cancer meds especially. There was a day not too long ago called "Black Monday" where 5 new promising cancer drugs were pulled by the FDA in one day, upsetting many oncologists who had high hopes and upsetting many cancer patients that were looking forward to trying it. This angle of the story NEVER gets reported.

Sid

:sarcasm:

It's a start. Now how about peer-reviewed scientific studies with appropriate controls for ALL supplements.

Time for the charlatans to stop making claims they cannot prove. That goes for all vitamins and supplements. Get those sleazebags off the TV like Enzyte, Head-On, etc.

It just requires what's in the capsule to be what the label says. Though there is already a requirement for little * leading to a box that says 'These claims have not been evaluated by the FDA etc...'

Still, it helps to know that what you are taking is actually what it says on the label and not some other stuff.