(KappaGuerra) “FDA issued warning letters for the unapproved stimulants BMPEA, the ephedrine analogue methylsynephrine, and DMHA in 2015, 2016, and 2019, respectively. Using Google, manufacturer’s websites, and the FDA’s websites, the team searched for evidence of recalls of the implicated products. Products that remained for sale online were purchased, and powder from these products was reconstituted and analyzed for the presence and quantity of FDA-prohibited ingredients using liquid chromatography-mass spectrometry.”

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All right jama so that’s the journal of the american medical association fda warning letters fail to result in removal of illegal supplement ingredients

That is what I’m looking at here here’s a little excerpt that I pulled out and thought was important reading and it’s in the description fda issued warning letters for the unapproved stimulants bmpea

The ephedrine analog methylphene or methylcyne ephrine and dmha in 2015 2016 and 2019 respectively using google manufacturers websites and the fda’s websites

The team searched for evidence of recalls of the implicated product products that remained for sale online were purchased and powder from these products was reconstituted and analyzed for the presence and quantity of fda prohibited ingredients using liquid chromatography mass spectrometry

All right what’s the source world online exclusive and again the title is the same one that’s here which is jama jama the journal of the american medical association fda warning letters failed to result in removal of the legal supplement ingredients

According to product recall reports just a portion of products containing illegal ingredients will recall following the issuance of warning letters all right

Let’s take a look this was written by mike montamorano associate editor at nutraceuticals world august 2 2022 the food and drug administration sends warning letters to companies marketing supplements or ingredients that the agency deems to be illegal and or fail to meet the definition of a dietary supplement

In order to develop an estimate of how many companies follow through with removing illegal and potentially dangerous substances from the dietary supplements market

A team of researchers led by peter cohen md of cambridge health alliance writing in jama track fda warning letters for unapproved stimulants present and products on the market

Okay so this guy peter cohen md he tracked fda warning letters for unapproved stimulant presence and products on the market that’s the first of the plot here

Let’s go on they assess the frequency at which these products were removed following the receipt of an fda warning letter specifically with warning letters which addressed amphetamine

Ephedrine and some other drugs which are known to carry serious health risks including hemorrhagic stroke and sudden death all right and this is kind of crazy

This has been going on for so many years and I never looked at it any information about before and I’m subscribed to this periodical I get a whole bunch of actual physical ones before

But I don’t think this one ever did come in a physical copy anyway I digress let’s see so ephedrine and some other drugs which are known to carry serious health risk

Including hemorrhagic stroke and sudden death quote whether fda warning letters lead manufacturers to recall or reformulate products is unknown we assess the frequency of product recalls and the presence of fda prohibited drugs in supplements after fda warning letters

The authors wrote okay I remember who are these authors it was a team I guess team of researchers led by peter cohen md of cambridge health alliance

Writing in the journal of the american medical association continuing fda issued warning letters for the unapproved stimulants b mpe a the ephedrine analog methylcynephrine

And dmha in 2015 2016 and 2019 respectively using google manufacturer’s websites and the fda’s websites the team searched for evidence of recalls of the implicated product

Products that remained for sale online were purchased and powder from these products was reconstituted and analyzed for the presence and quantity of fda prohibited ingredients using liquid chromatography mass spectrometry

It’s interesting how many things when tests are being done like analysis are so much the same like for example for a contaminated site to end up on the department of environmental quality or the environmental protection agencies list

Actually which is known as the national priorities list they go in and do the same thing they basically go into a site and they check for the nature and extent of the contamination

So it’s the same thing in everything and there’s a reason why I’m making a point about that there’s so many things that if you’re listening there’s so many different things that you can pull out that would be helpful for when you’re organizing certain campaigns

Let’s see right so the team search for evidence right products remain a sale or reconstituted all right of the 31 products targeted in warning letters for the presence of remember these chemicals molecules

These ingredients right what did they say are known to carry serious health risks including hemorrhagic stroke and sudden death so that’s where we are

So of the 31 of those that have those risks only one product was recalled by the manufacturer meanwhile 29% of the products remained online for an average of six years

After fda issued warning letters four of the nine products that were still for sale online listed the presence of at least one prohibited ingredient on the label

One product listed the same prohibited ingredient mentioned in a warning letter while three product labels declared other fda prohibited ingredients okay

That’s interesting there too something you hear about like when I was traveling around in asia and then the kickboxing matches and just some of the drug testing and how people got passed and stuff like that

Do whatever you want that’s one thing but another problem with somebody the one reasons why these kind of things are important is because there are some athletes who are not intentionally ingesting banned substances

And because some products are contaminated with them it’s causing them to test positive or things that they had no idea about this is again something been going on for years

I never really looked into it but here this popped up again over and over again into my feed so I’m taking a look at it let’s take a look at here so the last name was a cave

They left out of 31 only one which we called 29 remained on the shelf for an average of six years four of the nine products were still on sale and one of them listed one prohibited ingredient that was named in the letter

And then at least three other product labels declared other fda prohibited ingredients that were not necessarily in that warning letter apparently in some of these places

Seems like nobody’s even listening send us a warning letter let’s just keep selling it until I don’t know police officers come kicking outdoors down with guns

Let’s see five of the nine products still available on the market were found to contain at least one fda prohibited ingredient in total 29% of the products targeted by fda warning letters remained available for purchase

And most of them were adulterated with unapproved ingredients again I think this is quoting from the jama article quote says this study raises questions regarding the fda’s actions to ensure that manufacturers are compliant with the agency’s warning letters

The fda should consider ways to ensure that prohibited drugs are removed from supplements perhaps by testing products sold after warning letters and mandating recalls

Whenever products remain adulterated the authors concluded time to act on authority as the next section is labeled boldly here and listening in you will see that these links are here

The link is directly to this article so you can read it listening back where are we here all right time to act on authority megan olsen senior vice president and general counsel at the council for responsible nutrition

Said that warning letters alone aren’t consequential enough to be perceived as sufficient threats to bad actors wow that’s obvious right if people are keeping things on sale for six years on average

After the fda sends a warning letter that’s an understatement warning letters alone aren’t consequential enough to be perceived as sufficient threats to bad actors

Okay quote it is unfortunately the case that the agency is not doing its job when one can find the same rogue ingredients in the same bad product six years after warning letters have been issued

Olsen said oh she’s continuing this study demonstrates that warning letters alone are not viewed as sufficient threats by bad actors and outliers fda should stop assuming that everyone in the market wants to do the right thing

Fda has recently been asking for a new socalled prohibited act authority to clean up the industry she added in other words fda wants clear cut ability to address illicit substances that have never been marketed as drugs nor even studied for their potential effects

But are nevertheless marketed as supplements all right I don’t know you can read that the wording there and what she’s talking about the slippery slope

But I’m not going to get into that crn supports this legislative priority insofar as expanding the agency’s authority over substances that aren’t implicated by the drug preclusion clause of the dietary supplements health and education act

While the agency can mandate recalls of dietary supplement products it is only done in rare instances the agency often instead requests that companies conduct voluntary recalls I’m still quoting

Still continuing here these illicit substances may be currently caught in illegal no man’s land not supplements not drugs and without this new authority

Not clearly within the fda’s enforcement olsen said this simple change to the law currently part of the senate heelp or help committees user fee legislation

Would give fda capacity that much of the industry hold on let me start that again this simple change to the law currently part of the senate health committee’s user fee legislation would give fda capacity that much of the industry believes it already has

But fda has been requesting explicit statutory language to clarify all right that’s actually important so she’s basically saying that this change in the law will basically give the fda capacity that a lot of people in the industry thought they already had

So they already thought they could regulate more strictly than just sending for example these warning weathers we could definitely assume that’s what she’s getting at

Right so people assume that they had more power than just sending one another but this new law would make that more possible continuing like olson scott melville

President and ceo of the consumer health products association said that he also supports comprehensive reforms to offer fda clear authority to go after products that contain dangerous prohibited ingredients

This language they keep saying they offer fda clear authority to go after products that contain dangerous prohibited ingredients where’s the go after part

Let’s get to that let’s get to people kicking doors down or something they’re just going around testing things it’s independent researchers went around testing stuff

But nobody I mean I’m still not seeing okay let me stop and look at the rest of this all right so now somebody’s using stronger language there can be no tolerance for illegal products masquerading as dietary supplements

Especially after a manufacturer has already received an fda warning letter yet that is precisely what was found the troubling situation highlights the need for increased enforcement of current law by the fda and the department of justice

And the need for more comprehensive reform of dietary supplement regulation please that’s melville speaking continuing to speak again according to melville

The mandatory product listing another alphabet right mpl number okay according to melville the mandatory product listing mpl provision of the current user fee registration bill being considered by congress won’t go far enough beyond npl

He said fda should also be able to increase facility inspections and remote regulatory assessments the latter of which is an informal assessment of a facility that was introduced during the height of the covid 19 pandemic

Oh boy coven 19 still pop in the setup and shit it doesn’t belong in here we go I don’t expect anybody to know what I mean as the house and senate confer on fda user fee authorizations

The need to balance consumer access to safe and beneficial dietary supplements with fda’s ability to swiftly remove dangerous and illegal products from the marketplace should be recognized to ensure that any agree to reforms are meaningful and not reform in name only

Meldil said all right something changed at the fda that I don’t know about are they not anymore the fraud and death administration one more letters

Here we go npa what is npa so apparently npa saying fda should do more with the tools it has let’s find out what the mpa is and n as in nickel according to daniel fabricant

Phd president and ceo of the natural products association there’s the npa fda appears unwilling to take steps such as product seizures and injunctions

Which it already has the authority to do okay in contrast to crn npa does not support granting the agency more authority when it doesn’t utilize existing tools

Oh boy what is crn we just went over there all these letters right crn crn olson council for responsible nutrition right so the crn is the council for responsible nutrition

And now the npa is saying in contrast to the crn npa does not support granting the agency more authority when it doesn’t utilize existing tools okay that makes sense

Right so olsen from the crn is saying that they need to give the fda more authority because she’s saying that the fda does not have authority that the industry thinks it has

While daniel fabricant of the natural products association is saying that they do have some authority but they’re not even using that which they do have

At least that’s how I’m understanding it so far all right another point of contention is the fact that fta’s facility inspections have been declining in frequency sometime

Irrespective of funding fabricant said all right so he’s saying that the inspections are less and less and it doesn’t matter how much money they have

He noted that a report from the office of the inspector general concluded that even in response to significant inspection violations follow up from the agency to ensure corrections were made by the facility was rare

Who reads these freaking documents anyway this is so boring but informative at the same time somehow this study reaffirms fda’s performance failure gaps going back to a report published by the office of the inspector general in 2017

Companies who receive a warning letter are required to notify fda within 15 days of receipt of their warning letter and the specific steps they have taken to address any violations

Failure to do so is supposed to result in legal action including seizure and injunction see that’s what I’m talking about right there when I was talking about something actually being done

This is what we’re talking about this phrase seizure and injunction why are they just sending letters so it’s supposed to result in these this should be considered low hanging fruit for the agency

But it’s obvious there’s an element of willpower that’s absent these gaps we’re quoting again I can’t keep up look just come to read the documents these gaps in actions indicate that newer

Authorities to the fda clearly aren’t warranted when current authorities where problems have been located aren’t followed up with fabricant continued this study makes it clear the agency has adequate authority to pursue products masquerading as dietary supplements

The repeated absence of follow through requires oversight and accountability all right so the gist of this is the title says it all right fda warning letters failed to result in removal of illegal supplement ingredients

We got a little bit more in depth from a couple of different agencies here all the letters here we got fta we got j-a-m-a dmha is one of the ingredients

Right we got bmpa crannpac oh my gosh ceo scope at 19 and more that’s it we got details okay that’s on the record I looked at so now we have a little bit

More better idea of what goes on in some of these oversight agencies according to nutraceuticals world if you don’t get periodical from them maybe I’ll find a link from here

How do I even get these things I forgot it’s been probably something like 20 years since I’ve been receiving these periodicals all right and that’s it

This is 21 minutes and this is on the capacity at a martial arts maybe don’t see how it’s yet related but we’re going to see supplements are a big part of athletes lives

And if we’re getting stuff that’s contaminated with shit that we didn’t want in there in the very least causing some kind of disqualifications if somebody’s competing or even kill you