FDA to Over Regulate Nutritional Supplements

[mamayogibear]

Tell the FDA their Draft Guidance on NDIs is Bad for Consumers

On July 1, the US Food and Drug Administration issued draft guidance for complying with the New Dietary Ingredient (NDI) notification protocols required by the Dietary Supplement Health and Education Act (DSHEA)—seventeen years late.

The biggest problem is that this guidance will create such huge barriers for supplement manufacturers that it will be much more difficult and expensive to produce them. But of course, that means consumers would either have to pay much more for nutritional supplements, or else risk not being able to buy them at all if the manufacturer deems them too expensive to produce.

https://secure3.convio.net/aahf/site/Advocacy?cmd=display&page=UserAction&id=833

[mamayogibear]

I've noticed that this has gotten no replies. So do you gals just think that this will not happen and is a hoax or something? Sometimes I'm gullible but this got me worried and seemed to be for real!

[sosurreal09]

Oh it's totally real I have known about this a couple years. It's already happening in Europe I believe. IT IS BULL! "Vitamins are dangerous and kill people" you know...

[sosurreal09]

*sent*

[MsFortune]

I'd like proof that supplements and drugs are safe and effective before they are sold to consumers.  I'd like their manufacturing and purity to be overseen by a safety agency.  I don't see why - if they are safe and effective - requiring testing is a bad thing.  

[mzpuff]

Read and signed. this is really scary. makes me wonder, what will they come up with next

[stik]

Originally Posted by MsFortune 

I'd like proof that supplements and drugs are safe and effective before they are sold to consumers.  I'd like their manufacturing and purity to be overseen by a safety agency.  I don't see why - if they are safe and effective - requiring testing is a bad thing.  

I would like this too.  Right now, if a manufacturer calls something a "proprietary mixture" it can contain basically anything at all, as long as it also contains a tiny amount of the ingredient on the label.  Some companies have been selling capsules of basically just sawdust for years (usually at a substantial profit).  I think the time has come for higher standards there.  The petition lists some things as "minor differences" that don't sound minor to me at all, like changing the composition of a substance through heat or fermentation - that can be pretty major.  So can using a different part of a plant or a plant at a different stage in the life cycle.  I can see why the manufacturers want to maintain the status quo, but I think consumers would benefit from greater oversight.  

[sosurreal09]

I get what you guys are saying but the consumer needs to evaluate it themselves too. The reality is OTC drugs and prescription drugs ALL have side effects and can result in some horrible outcomes but they are tested and "safe" according to our FDA so I would rather research the brand myself, find supplements I want to use myself, and keep the big pharma and the FDA the heck out of it!

I only take supplements that are food based and I go through all the ingredients, I can monitor myself to see how they make me feel or if they seem to do anything at all, and I can choose whether or not to take them. Heck the supplements I take now are expensive enough but they have really helped me and I can not afford them if they go up in price!

You get what you pay for normally so if you go and get "vitamins" for $3 at walmart I would bet they aren't good quality and not worth the $3...and please don't categorize this under "poor people are too stupid to think" just like how the $1 menu isn't healthy but "people are too stupid" to not buy it b/c they are poor and uneducated. I mean come on go to any grocery store and how much of the garbage there isn't even real food? Why doesn't the FDA step in and fix that...? That would have a way bigger impact on this country than poor quality vitamins.

[MsFortune]

Originally Posted by sosurreal09 

I get what you guys are saying but the consumer needs to evaluate it themselves too.

++So do you expect consumers to do their own multi-year randomized clinical trials?    Because that is what you need to prove that something is effective and safe.  And then someone needs to audit the manufacturers to make sure that they are making what they say they are making and doing it in a safe way.  As a consumer, there is no way I can or will do those things.  I'd rather rely on a consumer protection agency to do this.  Otherwise I'm just looking at blog posts or partisan "news sites" and using my Google University degree and fooling myself into thinking that I am qualified to evaluate such things, with no real data and without relevant education.  

The reality is OTC drugs and prescription drugs ALL have side effects and can result in some horrible outcomes but they are tested and "safe" according to our FDA

++Before they are sold, all drugs (OTC and prescription) are rigorously tested.  That's how we know what the side effects are before they are sold.  And yes, they have these effects but the FDA evaluates the known side effects and risks of a drug compared to the benefits.  And then they are approved (or not) based on this information.  And then the information is made public so consumers can have some real data if they want to use the data.  

so I would rather research the brand myself, find supplements I want to use myself, and keep the big pharma and the FDA the heck out of it!

++Most people are not scientists who can really understand what they research, and there is not real data on most supplements out there, so most people can't do real research.  And as for researching the individual brands - short of auditing a manufacturing facility, I don't know how that could be done.  Maybe you have other ways you are researching this that you can recommend?

I only take supplements that are food based and I go through all the ingredients, I can monitor myself to see how they make me feel or if they seem to do anything at all, and I can choose whether or not to take them. Heck the supplements I take now are expensive enough but they have really helped me and I can not afford them if they go up in price!

++It's good that you feel that they work for you.  I think most consumers deserve some proof that what they are taking is safe and effective.  I want that proof.  

You get what you pay for normally so if you go and get "vitamins" for $3 at walmart I would bet they aren't good quality and not worth the $3...

++Inflating prices does not make something better for you.

and please don't categorize this under "poor people are too stupid to think" just like how the $1 menu isn't healthy but "people are too stupid" to not buy it b/c they are poor and uneducated.

++I think people - poor and not poor - deserve to have a consumer protection agency that tests for safety and effectiveness.  Most people are not going to do any research before they purchase things.  

I mean come on go to any grocery store and how much of the garbage there isn't even real food?

++I'm not sure what you mean here.

Why doesn't the FDA step in and fix that...?

++That's a false dichotomy.  If you think that the FDA should get involved in the lack of real food at the grocery store (I think that is what you are saying), then push for that.  Call your senator.  That does not mean that we do not deserve a consumer protection agency to make sure that the supplements that we are sold are safe and effective.  

That would have a way bigger impact on this country than poor quality vitamins.

++It's all supplements, nutraceuticals, homeopathy, etc - not just vitamins.  

[Turquesa]

Ummmmmmmmm, ladies?  Not 'spose to debate or post disagreement in the Activism forum.  Now that there's (officially?) less moderation here, I thought I'd say it. 

Thanks for bringing this to my attention Mamayogibear!  Scary stuff....

[MsFortune]

woa - respectful discussion where people present differing opinions and fact are not allowed?  that can't be.  We are all grown ups here.  

[stik]

The forum guidelines seem to reflect the old UA, which banned a lot of things including most debate, all mentions of certain practices, and taking issue with other posters.  But perhaps the mods would be willing to move this to the appropriate forum if they think it would be better there.

Personally, I am deeply irked by hyperbolic language (like "The FDA is going to outlaw nutritional supplements") to describe what is happening here - the FDA is going to set safety and quality standards for nutritional supplements, and monitor their production.  

[Turquesa]

Here are the current guidelines:

In addition - if you do not agree with a call to action/rally/protest, please do not post to the thread. Do not discuss the thread, or the original poster of the thread. If you find a counter cause of one posted here to be worthy, please start a new thread in Activism. THIS IS NOT A DEBATE BOARD. Posts that move into debate will be deleted from the thread, and alerts may be issued. In cases where the thread continually moves into debate, all posts following the OP will be removed and the OP locked and left for reference.

No shooting the messenger!

[stik]

I'm not really interested in debating the UA and whether or not the forum description accurately reflects recent changes in a thread on proposed changes to FDA regulations for nutritional supplements.  I'd like to stick to the topic.  I think the correct course of action for your concern, Turquesa, would be to click the funky little alert flag and alert the mods.  In my experience, they're really good at handling these interpretive issues, and we really don't have to make guesses about what they would do.  

I'm intrigued by the suggestions that the FDA should do more to help consumers identify "real" food in grocery stores.  I think that industry efforts to meet this need have been pretty pathetic so far - I can now buy Lucky Charms that have a label claiming they are high in fiber.  I find this unconvincing.  But aren't there some new labels out in grocery stores that label things high in nutrients?  I'm not sure who is behind that effort, and I haven't really noticed the labels yet in my local grocery store, but I think it's a good thing.  Assuming it's happening.  I thought I saw pics of an event with Michelle Obama and a lot of bright green tags in a Wal-Mart.  I don't shop at Wal-Mart, but I'm looking forward to the day the bright green tags hit my local Stop-and-Shop.  

[mamayogibear]

This doesn't just pertain to formulated supplements like in pill form but also bulk food items that are marked as 'nutritional supplements' and not 'food'. I am on food stamps and since new years a large amount of bulk items have stopped being considered food and can't be bought with food stamps. For instance bulk red raspberry leaf, psyllium, xylitol, nettle leaf, bee pollen etc... Almost half of my grocery list is no longer considered 'food' and falls into the category of nutritional supplements now! I don't think it is just the store I shop at either (Fred Meyer in WA state) but maybe it is.

The over regulation of whole food items is what concerns me the most about this. I do take a few vitamins but have a whole arsenal of herbs and spices that I consider medicinal and nutritional.

Thanks for the feedback thus far, I enjoy reading the opinion of others even if I disagree! But as PP stated please keep within the UA;) I'm not trying to start a debate here, I just hope to get people thinking about what is considered a 'nutritional supplement' instead of food and how regulation of such items would have an adverse impact on many people. Sorry if I came off as being snarky or instigating a diatribe!

[stik]

For instance bulk red raspberry leaf, psyllium, xylitol, nettle leaf, bee pollen etc... Almost half of my grocery list is no longer considered 'food' and falls into the category of nutritional supplements now! 

I have to admit, I don't think of those things as food.  I can't think of a way to make a meal out of red raspberry leaf, psyllium, or xylitol.  But I also don't think the issue of what food stamps cover is addressed by the petition you posted.  The food stamp program is administered by the USDA, not the FDA.  The FDA is part of the Department of Health and Human Services.  

[mamayogibear]

Food stamps have nothing to do with the OP! I was just pointing out that those items are no longer classified as food like they once were and probably would not have realized that if I did not have to pay for them with cash which I don't mind doing as long as I can keep going to the store and buy them. They are now considered nutritional supplements and would fall subject to the new regulation if it were to go through. However gum and candy are considered food!!! How can you make a meal out of that, shouldn't they be considered un-nutritional supplements? Drinks at stores are considered food, like teas in tea bags but bulk teas like rrl are not food now. Also lots of people use xylitol in place of sugar, so to you is sugar not a food item? And psyllium can be used to bulk up homemade vegan pudding or yoghurt.

I think you missed the whole point of my previous post which is items that were once called food because they can be used in cooking are no longer being classified as food. Items are being considered nutritional supplements instead so they will be taken off the shelf if the FDA begins to regulate supplements in an extreme manner.
 

Originally Posted by stik 

I have to admit, I don't think of those things as food.  I can't think of a way to make a meal out of red raspberry leaf, psyllium, or xylitol.  But I also don't think the issue of what food stamps cover is addressed by the petition you posted.  The food stamp program is administered by the USDA, not the FDA.  The FDA is part of the Department of Health and Human Services.  

[stik]

The FDA's goal is not to remove the products from the shelves.  The FDA wants to regulate production.  

FDA regulation might lead to some products being withdrawn from the market.  If that happens, it will likely be because the producers determine that meeting FDA regulations will be too costly.  That choice would imply that the withdrawn products fell well short of meeting manufacturing standards for purity and safety.  

FDA regulation will probably raise the price of a bunch of products.  That problem could be wider spread, but it still doesn't warrant the claim that the FDA is trying to outlaw nutritional supplements. You will still be able to go to stores and purchase supplements with money.  

If what food stamps cover is irrelevant to the issue with the FDA, then so is my opinion of xylitol and psyllium.

[kittywitty]

Originally Posted by stik 

I have to admit, I don't think of those things as food.  I can't think of a way to make a meal out of red raspberry leaf, psyllium, or xylitol.  But I also don't think the issue of what food stamps cover is addressed by the petition you posted.  The food stamp program is administered by the USDA, not the FDA.  The FDA is part of the Department of Health and Human Services.  

I can for some of those things- RRL is a tea. MUCH more nutritious than gum, candy, or half of the junk in grocery stores.

I'm all for regulation, I just don't want them clearing the shelves without warning before they do. I depend upon many of my vitamins!

[Alenushka]

I want more regulation. I am sick and tired of hearing lead and god knows what else found in supplements. If I am paying $$$, I would like it to be safe.

Also, some things I use but I have no idea what long term side effects are as no one has to do any studied. I take Peppermint Oil capsules for IBS and it works great....but is is safe to take for years? Who knows.  It is very disconcerting.