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Kennedy asks FDA to revise 'self-affirm' rule for food ingredient safety
reuters.com ^ | Mar 11, 2025 | Reuters

Posted on 03/11/2025 9:37:42 AM PDT by ransomnote

March 10 (Reuters) - U.S. Secretary of Health and Human Services Robert Kennedy Jr. directed the Food and Drug Administration on Monday to revise safety rules to help eliminate a provision that allows companies to self-affirm that food ingredients are safe.

SNIP

"For far too long, ingredient manufacturers and sponsors have exploited a loophole that has allowed new ingredients and chemicals, often with unknown safety data, to be introduced into the U.S. food supply without notification to the FDA or the public," he said in a statement.

Currently, the FDA strongly encourages manufacturers to submit notices under a rule known as Substances Generally Recognized as Safe, but they can also have the option to self-affirm the use of a substance without notifying the FDA.

Eliminating this pathway would require companies wishing to introduce ingredients in foods to publicly notify the FDA of their intended use and submit the supporting safety data, the HHS said.


(Excerpt) Read more at reuters.com ...


TOPICS: Miscellaneous
KEYWORDS: fda; foodingredients; foodsafety; rfkjr

1 posted on 03/11/2025 9:37:42 AM PDT by ransomnote
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To: ransomnote

Kennedy is quietly doing a good job


2 posted on 03/11/2025 9:39:47 AM PDT by Fai Mao ( Democrats need to go to prison.)
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To: Fai Mao

Yes, he is.


3 posted on 03/11/2025 9:41:18 AM PDT by madison10
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To: ransomnote

Big Food crams all kinds of poisons into foods.

Every single ingredient needs to be listed on labels.


4 posted on 03/11/2025 9:44:22 AM PDT by Arcadian Empire (The Baric-Daszak-Fauci spike protein, by itself, is deadly.)
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To: Fai Mao

Like he told us during his campaign: he knows exactly what to do.


5 posted on 03/11/2025 9:47:41 AM PDT by Rural_Michigan
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To: ransomnote

> a provision that allows companies to self-affirm that food ingredients are safe <

Wow. That’s some crazy stuff right there. I wonder if it would work elsewhere.

IRS agent: “Your tax return looks very suspicious. For one thing, it’s filled with all sorts of errors.”
Me: “I self-affirm that my return is 100% correct. So quit yer yapping.”


6 posted on 03/11/2025 9:48:21 AM PDT by Leaning Right (It’s morning in America. Again.)
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To: Rural_Michigan

If hadn’t endorses DJT I would have voted for him for POTUS. He would have been a great one. As it is I’m thrilled he is where he is


7 posted on 03/11/2025 9:48:56 AM PDT by Rural_Michigan
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To: ransomnote

We all know how top-down, centralized, Fed.gov regulation always benefit insiders and large corporations, which have the money and connections to game and influences rules set in Washington DC. This is true in finance, pharma, media, and especially AGRICULTURE.

Therefore, RFK needs to give outright unequal and favorable treatment in regulation, tax, penalties, oversight etc. etc.. to family farms and small food processors.

Consider it an aggressive “affirmative action” program for family, local, small-scale agriculture and food processing.


8 posted on 03/11/2025 9:58:26 AM PDT by PGR88
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To: Rural_Michigan

“If hadn’t endorses DJT I would have voted for him for POTUS. He would have been a great one. As it is I’m thrilled he is where he is”

You would have voted against Trump?


9 posted on 03/11/2025 10:02:03 AM PDT by TexasGator (I1.11.'1I1.I'')
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To: Leaning Right
... “I self-affirm that my return is 100% correct..."...

Actually, one does that by signing the return and the odds against audit are pretty good.

These rules are certainly hard to generalize. Does every ingredient have to submit to extensive and costly and time-consuming testing? For the most part, I think we can assume most additives are faithfully believed to be safe by the maker. They aren't in business to harm people, by and large. I think of the Amish wanting to sell raw milk ....

10 posted on 03/11/2025 10:08:53 AM PDT by gloryblaze
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To: gloryblaze

> They aren’t in business to harm people, by and large. <

True that. But unfortunately, too many companies are willing to cut corners to increase their profit margins. That’s where the problem is.

A good example of this is Lumber Liquidators. They got caught importing cheap flooring from China, flooring that had too high a formaldehyde content. It was much more than what they officially listed. For sure Lumber Liquidators didn’t want to deliberately hurt their customers.

But they did gamble with their customers’ health, just to save a buck.

https://www.foxnews.com/us/lumber-liquidators-paying-33m-to-settle-us-fraud-charges


11 posted on 03/11/2025 10:24:13 AM PDT by Leaning Right (It’s morning in America. Again.)
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To: Leaning Right; gloryblaze
They aren't in business to harm people, by and large.

I would say this:

They are in business.
They worry about profits.
They don't worry too much about harming people.

12 posted on 03/11/2025 10:26:54 AM PDT by ClearCase_guy
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To: Leaning Right
... They got caught importing cheap flooring from China, flooring that had too high a formaldehyde content. It was much more than what they officially listed....

That is a known unsafe substance, and if they knowingly mislabeled it's amount, then that is clearly fraud. And they paid a price, which is a lesson to others.

13 posted on 03/11/2025 10:37:31 AM PDT by gloryblaze
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To: ClearCase_guy
... They are in business.

They worry about profits.

They don't worry too much about harming people.

Of course businesses have to worry about profits. I suspect food companies worry a great deal about harming people, too.

If you really don't think they give a hoot in heck, we will just have to agree to disagree.

14 posted on 03/11/2025 10:40:42 AM PDT by gloryblaze
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To: ransomnote

https://www.cspinet.org/sites/default/files/attachment/GRAS%20Comment%20FINAL_0.pdf
Gamma-amino butyric acid (GABA) is a neurotransmitter that was self-determined GRAS by industry for use in beverages, chewing gum, coffee, tea, and candy. GABA was declared GRAS despite the fact that estimated exposures were in excess of what the manufacturer considered safe. In addition, the submitter relied on unpublished safety studies, and failed to consider existing exposures.293 When FDA identified these concerns, the company withdrew its notice. While the company told NRDC that it would not market the product for use in food, it continued to use the ingredient in dietary supplements. NRDC also identified five food products marketed by other companies with GABA as a named ingredient, including bottled tea and nutrition bars.

- - - - -

Sweet lupin protein, fiber, and flour have been declared GRAS by an Australian firm for use in baked goods, dairy products, gelatin, meats, and candy, despite concerns that the chemicals could cause allergic reaction in people with peanut allergies.

- - - - - -

Theobromine was declared GRAS by a U.S. company for use in bread, cereal, beverages, chewing gum, tea, soy milk, gelatin, candy, and smoothies, despite having an estimated consumption rate that was more than five times the safe consumption level reported by the company’s consultant. On top of this already considerable cause for alarm, the notification did not provide explanations for various safety concerns raised by animal testing of theobromine, including testicular degeneration and delayed bone formation.297 Nevertheless, NRDC found that theobromine was a named ingredient in more than 20 food products, including isotonic waters, nutrition bars, and diet foods.


15 posted on 03/11/2025 10:52:28 AM PDT by Doctor Congo
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To: Doctor Congo

The more I read ingredient labels and look them up on the web, the more I retreat from purchasing ‘normal’ items like...I dunno...table salt. (Yes it turns out table salt is said by some to be bad for you, as is most pink salt. It’s additives and impurities that are concerning.)

The US subsidizes soybeans and yet I’ve read a well referenced book (The Hidden Dangers of Soy) which made me more cautious, and then an article by Brian Cates identifying the problems with pushing Americans off of butter fat/tallow and onto ‘seed oils’ (safflower, soybean, peanut etc.) is strongly correlated with sky rocketing health problems.

I’ve seen GRAS ratings on the additives in my supplements, and I (literally) am not buying many of those ingredients anymore. I simply do not understand why my calcium tablets contained Titanium Dioxide for ‘whiteness’.

Many of these GRAS ratings say it’s safe in small amounts, but how much is ‘small’ and how much of an additive ingredient they list is in other supplements I take?

I note that mannitol is in odd foods and chewable supplements, and carnuba wax is in some gummie vitamins. Yes, carnuba wax. I looked it up and it is GRAS. But if you read further, its safe in small amounts otherwise it can disrupt the biome of the intestine. Many of these GRAS approved items say that in large (how large?) amounts they could disrupt the balance of good bacteria in the intestine...you know...the kind of beneficial bacterial which underpins your immune system.

I’ve just been looking at maltodextrin. It’s added to foods in two different forms. One is an indigestible starch and the other is a form of sugar - they are added to different products to deter clumping in powdered products and make such powders ‘free flowing’.

SO from the reading I’ve done, there’s caution about eating substances your intestines can’t digest (disrupt good bacteria). Then the sugar form of Maltodextrin which can be digested can cause problems for those with diabetes. I don’t personally know anyone with diabetes or I would ask if they are aware that the latter form of Maltodextrin can spike their blood sugar, but manufacturers are not required to list it as an ‘added sugar’. They do have to list it as a carbohydrate. That seems cheesy to me because the consumer may assume the carbs are part of the primary product and not the additive- I just hope diabetics know.

So the table salt in my house lists Maltodextrin on the label. I assume it’s the indigestible starch version. I switched to Celtic salt and noticed a) it tastes better and B) it’s saltier. Just how much maltodextrin is in my table salt that it dilutes the flavor?

Oh, and carageenan. That one is in people food and pet foods. I remember some talking head laughing about paranoid people worried about that word - carageenan, and that it was perfectly safe as it is made from seaweed. Then I found a Pub Med article detailing the potential side effects and I recall remarking to a friend in an email: Carageenan is much worse than I thought. Then I read an article in a pet magazine saying not to feed your pet foods with carageenan.

I’ve always been told ‘natural flavors’ is where they hide the worst chemicals. Avoid the generic ‘natural flavors’ or so I’ve been told.


16 posted on 03/11/2025 11:28:01 AM PDT by ransomnote (IN GOD WE TRUST)
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To: Leaning Right

👍🤣👍


17 posted on 03/11/2025 11:40:21 AM PDT by SoConPubbie (Trump has all the right enemies, DeSantis has all the wrong friends.)
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To: ransomnote

The reason processed foods taste “better”, bread is softer, lemonade has more body, etc., is because of food additives. When RFKjr is able to get them removed or decreased, those foods may not taste the same, and we may be disappointed, but we’ll get used to the changes. Decades ago, A high friend went to Germany; she said common foods, such as ketchup, tasted nothing like American counterparts; yes, we will have to adjust, but we will be better for it.


18 posted on 03/11/2025 1:55:16 PM PDT by Flaming Conservative ((Pray without ceasing))
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