Deregualtion, no regulation meme

[icerat]

The FDA should be the agency to test anything marketed for ingestion by humans

So you want the FDA to test all food and drinks that are marketed?

 

[Puppycow]

That is admittedly a bipartisan bill, the supplement industry has senators from both parties in their pocket.

Tom Harkin (D) was also a big supporter of this iirc.

 

[Puppycow]

So you want the FDA to test all food and drinks that are marketed?

How about random samples. Of course they can't test it all, but if they tested say 1000 different products selected randomly each year, in different categories, that could keep them honest. If the random tests show that certain categories of goods, such as herbal supplements, are more likely to not contain what they claim to contain, they could focus more on those. Companies that fail would get extra scrutiny if they also sell other products.

 

[xjx388]

But the FDA isn't the agency who enforces the laws you are citing, but the FTC. So we need to give the FDA much broader regulatory control over much larger sections of the retail world then.

There's no reason why the two agencies can't handle the different aspects. The FDA does indeed have authority over supplements and the FTC has control over false advertising offenses. I see no need to expand the regulatory powers of either one.

Consumers who are interested in these products can educate themselves on what they should be looking for. Independent testing companies can offer their verification services. Provable problems can be prosecuted. No need for more regulation.

 

[casebro]

Already a thread in 'science'

http://www.internationalskeptics.com/forums/showthread.php?t=288376

 

[xjx388]

How about random samples. Of course they can't test it all, but if they tested say 1000 different products selected randomly each year, in different categories, that could keep them honest. If the random tests show that certain categories of goods, such as herbal supplements, are more likely to not contain what they claim to contain, they could focus more on those. Companies that fail would get extra scrutiny if they also sell other products.

That is what they currently do for food products but it isn't a big priority when it comes to supplements:

In that FDA has limited resources to analyze the composition of food products, including dietary supplements, it focuses these resources first on public health emergencies and products that may have caused injury or illness. Enforcement priorities then go to products thought to be unsafe or fraudulent or in violation of the law. The remaining funds are used for routine monitoring of products pulled from store shelves or collected during inspections of manufacturing firms. The agency does not analyze dietary supplements before they are sold to consumers. The manufacturer is responsible for ensuring that the "Supplement Facts" label and ingredient list are accurate, that the dietary ingredients are safe, and that the content matches the amount declared on the label. FDA does not have resources to analyze dietary supplements sent to the agency by consumers who want to know their content. Instead, consumers may contact the manufacturer or a commercial laboratory for an analysis of the content.

 

[theprestige]

I can buy a bottle of aspirin at the dollar store containing more than a hundred tablets, and all of them will contain 325 mg of aspirin. For a dollar.

I can't tell if you're claiming that the aspirin manufacturers you buy from have your trust that their quality, consistency, and honesty meet your expectations; or if you're claiming that the FDA inspects and verifies every single aspirin tablet in every single bottle of aspirin sold in every store in the nation.

Either way, could you share with us some of the evidence that has led you to the conclusion hilited above?

 

[ponderingturtle]

There's no reason why the two agencies can't handle the different aspects. The FDA does indeed have authority over supplements and the FTC has control over false advertising offenses. I see no need to expand the regulatory powers of either one.

Consumers who are interested in these products can educate themselves on what they should be looking for. Independent testing companies can offer their verification services. Provable problems can be prosecuted. No need for more regulation.

Got it, there is nothing actually wrong with the current situation and so nothing needs to be done. The supplement industry is perfectly well regulated.

 

[ponderingturtle]

I can't tell if you're claiming that the aspirin manufacturers you buy from have your trust that their quality, consistency, and honesty meet your expectations; or if you're claiming that the FDA inspects and verifies every single aspirin tablet in every single bottle of aspirin sold in every store in the nation.

Either way, could you share with us some of the evidence that has led you to the conclusion hilited above?

Manufacturers of real medication have very strict regulation about how they need to maintain quality control to insure that they have consistent and accurate amounts of medication in each pill.

Manufactures of supplements do not have these regulations and audits of their process.

 

[Dr. Keith]

Just in case anyone is interested in USP...

http://en.wikipedia.org/wiki/United_States_Pharmacopeia

They're actually a pretty useful organization, that most people don't even know exists.

A few interesting things to note about USP:

1. They are not associated with USP Labs, the sports supplement company linked with liver illness.

2. How many consumers catch this distinction between USP and USP Verified:

USP also conducts verification programs for dietary supplement products and ingredients. These are testing and audit programs. Products that meet the requirements of the program can display the USP Verified Dietary Supplement Mark on their labels. This is different from seeing the letters “USP” alone on a dietary supplement label, which means that the manufacturer is claiming to adhere to USP standards. USP does not test such products as it does with USP Verified products.

3. In my exposure to USP's Verification program, it seemed far less robust than I would imagine most people assume. If one is intentionally using cheaper materials it would not be hard to do so while maintaining USP Verification. Those verification fees are pretty stout, so USP is not really trying to "bust" their verified brands, so much as make sure they have paperwork to cover their tails when their verified brand gets busted.

4. USP has discretion over who it verifies, thereby creating a very odd barrier to entry for smaller companies, even beyond their heavy fees.

In other words, as good as USP is, it is also a pretty good case study of where a proper regulatory body could be far more effective.

 

[blutoski]

A few interesting things to note about USP:

1. They are not associated with USP Labs, the sports supplement company linked with liver illness.

2. How many consumers catch this distinction between USP and USP Verified:

3. In my exposure to USP's Verification program, it seemed far less robust than I would imagine most people assume. If one is intentionally using cheaper materials it would not be hard to do so while maintaining USP Verification. Those verification fees are pretty stout, so USP is not really trying to "bust" their verified brands, so much as make sure they have paperwork to cover their tails when their verified brand gets busted.

4. USP has discretion over who it verifies, thereby creating a very odd barrier to entry for smaller companies, even beyond their heavy fees.

In other words, as good as USP is, it is also a pretty good case study of where a proper regulatory body could be far more effective.

There's also the transparency about criteria and incentive.

Specifically, I have advised my clients who are interested in losing weight to ignore private vetting programs that provide front-of-box icons. They're all money-making schemes from what I can tell. Remember: the consumer is not their customer, it's the business paying for the certification. There is a history of downward slide into deference to industry preference at the cost of consumer protection.

Examples are: Canadian Heart and Stroke Foundation's "Health Check" ([cancelled] a few months ago, but not before a decade and a half of defrauding consumers), Canadian Diabetes Seal, Juvenile Diabetes Research Foundation Approved. There are others. They all started with the best intentions, but it doesn't take long to recognize that the manufacturers are the customer and the consumer's eyes are the product.

 

[thaiboxerken]

Supplements and herbs should fall under FDA regulation, but because some woo-believer wanted, they are considered foods that are not regulated. I don't know if the woos were Repuglican or Demograts but it is a problem.

 

[xjx388]

Supplements and herbs should fall under FDA regulation, but because some woo-believer wanted, they are considered foods that are not regulated. I don't know if the woos were Repuglican or Demograts but it is a problem.

They DO fall under FDA regulation. They don't have as strict rules about them as do "dangerous" substances like prescription drugs but they are indeed regulated. Supplement manufacturers cannot make unproven claims, they must be manufactured under certain guidelines, etc:

Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded. That means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of DSHEA and FDA regulations.

FDA is responsible for taking action against any adulterated or misbranded dietary supplement product after it reaches the market.

 

[thaiboxerken]

It is my opinion that supplements should fall under the OTC drug regulations at the minimum.
The current regulations are not good enough.

 

[blutoski]

Supplements and herbs should fall under FDA regulation, but because some woo-believer wanted, they are considered foods that are not regulated.

By "some woo-believer" are you referring to the electorate or the politicians?

I don't know if the woos were Repuglican or Demograts but it is a problem.

My impression is that the primary driver was the supplement producers, who felt restricted by the general rule of truth in advertising. DSHEA was a compromise that allowed them to market untested, unproven, and even disproven products, as long as they didn't explicitly say it cured or treated a disease.

 

[Foolmewunz]

The Food and Drug administration, but they don't get to do that because Senator Orrin Hatch, a Republican, introduced the Dietary Supplement Health and Education Act of 1994.

I cannot recall his name, but Hatch has a tag-team partner on the other side of the aisle. Neither are voting their beliefs, necessarily, but those of their donors. They both top the list of funds received from the supplements and magic potions lobbyists.

Let's not try to brand this solely a GOP problem. It's a money problem.

 

[Beerina]

Manufacturers of real medication have very strict regulation about how they need to maintain quality control to insure that they have consistent and accurate amounts of medication in each pill.

Manufactures of supplements do not have these regulations and audits of their process.

These are issues of fraud, not regulation. They were given a pass on what constitutes ingredients, as well as direction on threading the needle with allowable but fraudulent health claims.

Good luck with that. "Congratulations! Testing shows it actually contains the stated amount of utterly useless herb X!"

 

[thaiboxerken]

Don't we use the government as an agency to regulate against fraud?

 

[ponderingturtle]

These are issues of fraud, not regulation. They were given a pass on what constitutes ingredients, as well as direction on threading the needle with allowable but fraudulent health claims.

Good luck with that. "Congratulations! Testing shows it actually contains the stated amount of utterly useless herb X!"

And how is one supposed to detect fraud?

 

[The Don]

And how is one supposed to detect fraud?

Maybe in the new unregulated age, private companies will analyse products at their own cost and then sue the manufacturer in the event that they don't come up to specification. These companies will have tow income streams, the payouts from such litigation and preemptive payments from manufacturers who may not want their products subjected to such scrutiny.

Not only will this protect the consumer but will create a whole new sector of privately owned job and wealth creators (as opposed to the government-run leeches who currently provide a more comprehensive service at a much lower cost). I cannot see how this could possibly work against the best interests of the consumer