Reuters: FDA to screen all imports, exemptions for low-value shipments revoked

[Pinmebaby1moretime]

"it will now review all imports of the products it regulates regardless of their quantity or value."

Are we forgetting that the items shipped are not marked as items that they regulate, but as "buckles" and "data cables?"

No hate but could we please not divulge specific info like what packages are marked as? Maybe i’m being paranoid but the less info out there the better. I just need more Reta and Lipo-b guys 😭😭

 

[indolent]

I only trust indignataries who begin with "So friends,"

 

[zpped]

Sorry if I sound rude you aren’t thinking clearly… How do they get shipments to the US warehouses from China in the first place? International shipment!

They can’t keep infinite US inventory they would need to spend a ton of money to do this as well as dealing with cold chain since inventory would be stored a long time. I doubt they have to do any of that now they get batches in and it’s sold quickly so they don’t have to keep inventory too long.

Yup, because nothing illegal ever makes it into the US...
But it will definitely change things. Probably make it more expensive, but it's already at absurdly low prices compared to 1 or 2 years ago.

 

[tncc_rn]

Yup, because nothing illegal ever makes it into the US...
But it will definitely change things. Probably make it more expensive, but it's already at absurdly low prices compared to 1 or 2 years ago.

I'm going to go on record stating it probably won't even make it more expensive in the future. May slow down the price decline, but not more expensive...

 

[Latlee]

Looks like I need to put another order in tonight before it is too late...Articles like this make me nervous

Definitely makes me nervous. I have Bac water from Canada that has been sitting in customs for two weeks now.

 

[tncc_rn]

Definitely makes me nervous. I have Bac water from Canada that has been sitting in customs for two weeks now.

I had B-12 injectable 30ml bottles from Canada that Customs held for 27 days. In the end they released it and it got delivered. Don't lose hope till a seizure notice shows up.

 

[KYRivianMan]

I had B-12 injectable 30ml bottles from Canada that Customs held for 27 days. In the end they released it and it got delivered. Don't lose hope till a seizure notice shows up.

With the heat and sitting in a sweltering warehouse for a month or longer is degradation a concern? I am seeing some things degrade 1-3% and other peptides/ solutions degrade 50-85% . That info valid?

 

[zpped]

With the heat and sitting in a sweltering warehouse for a month or longer is degradation a concern? I am seeing some things degrade 1-3% and other peptides/ solutions degrade 50-85% . That info valid?

1) B-12 is a vitamin not a peptide.
2) Lyophilized peptides degrading are not a concern. It won't matter on that scale.

 

[KYRivianMan]

1) B-12 is a vitamin not a peptide.
2) Lyophilized peptides degrading are not a concern. It won't matter on that scale.

In my 38 years of being a DVM and using a variety of peptides for animal health throughout my career, hydrolysis and degradation has always been a concern.But, I am always learning. Heck I have been on this forum for over a year and still an Apprentice. Lol

* I realize that B-12 is not a peptide, hence why I stated peptides and “Solutions”. B12 should store it at room temperature between 59°F and 85°F otherwise high rate of degradation occurs.

Peptides, especially in solution, can be sensitive to heat, leading to degradation through various mechanisms. While short peptides may refold after heat exposure, prolonged or high-temperature exposure can cause irreversible changes like hydrolysis of peptide bonds, denaturation, and aggregation.

Mechanisms of Peptide Heat Degradation:

• Hydrolysis:
  The most common pathway for peptide bond cleavage. Heating in aqueous solutions accelerates hydrolysis, breaking the peptide chain.
  
  
• Denaturation:
  High temperatures can disrupt the secondary and tertiary structures of peptides, especially those with well-defined structures. However, many short peptides can refold upon cooling.
  
  
• Chemical Instability:
  Heat can trigger other chemical reactions, including oxidation, deamidation, racemization,and isomerization, leading to peptide degradation.
  
  
• Physical Instability:
  Changes in secondary structure, adsorption, aggregation, and precipitation can also occur due to heat exposure.

Factors Affecting Peptide Heat Stability:

• Temperature:
  Higher temperatures accelerate degradation. Short-term exposure to room temperature (up to 30°C) is generally tolerable, but prolonged exposure can cause issues.
  
  
• pH:
  Changes in pH can influence peptide stability and the rate of degradation reactions.
  
  
• Peptide Sequence and Structure:
  The amino acid composition and the presence of specific secondary structures affect heat stability.
  
  
• Solution Conditions:
  Factors like the presence of salts, detergents, and other additives can affect peptide stability.

Practical Considerations:

• Storage:
  Dry peptides are generally stable at room temperature for short periods, but long-term storage is best at -20°C or lower, according to NIBSC.
  
  
• Handling:
  Reconstituted peptides in solution should be stored appropriately and used promptly to minimize degradation.
  
  
• Exposure to Heat:
  Peptides in solution should ideally be kept below 25°C for extended periods. Short-term exposure to room temperature may be acceptable, but prolonged exposure should be avoided, according to Intercom.

 

[zpped]

Peptides, especially in solution,

But they aren't in solution. Which is why I said "Lyophilized peptides". (Even in solution the degradation is surprisingly small for something like Tirz).

 

[Windingroads06]

I’m interested in how the logistics of this will work. Customs is the agency that screens this stuff. I am unaware of FDA employees opening packages at ports of entry.

Exactly. Is CBP can't get the job done, how is the FDA getting it done?

 

[Windingroads06]

It was they petitioned the fda to help so no more Americans are hurt/poisoned.

It was politicians who take money from BP. Saying they were acting on behalf of the constituency of whom about s third are morbidly obese and have multiple co morbid conditions.

 

[Windingroads06]

In my 38 years of being a DVM and using a variety of peptides for animal health throughout my career, hydrolysis and degradation has always been a concern.But, I am always learning. Heck I have been on this forum for over a year and still an Apprentice. Lol

* I realize that B-12 is not a peptide, hence why I stated peptides and “Solutions”. B12 should store it at room temperature between 59°F and 85°F otherwise high rate of degradation occurs.

Peptides, especially in solution, can be sensitive to heat, leading to degradation through various mechanisms. While short peptides may refold after heat exposure, prolonged or high-temperature exposure can cause irreversible changes like hydrolysis of peptide bonds, denaturation, and aggregation.

Mechanisms of Peptide Heat Degradation:

• Hydrolysis:
  The most common pathway for peptide bond cleavage. Heating in aqueous solutions accelerates hydrolysis, breaking the peptide chain.
  
  
• Denaturation:
  High temperatures can disrupt the secondary and tertiary structures of peptides, especially those with well-defined structures. However, many short peptides can refold upon cooling.
  
  
• Chemical Instability:
  Heat can trigger other chemical reactions, including oxidation, deamidation, racemization,and isomerization, leading to peptide degradation.
  
  
• Physical Instability:
  Changes in secondary structure, adsorption, aggregation, and precipitation can also occur due to heat exposure.

Factors Affecting Peptide Heat Stability:

• Temperature:
  Higher temperatures accelerate degradation. Short-term exposure to room temperature (up to 30°C) is generally tolerable, but prolonged exposure can cause issues.
  
  
• pH:
  Changes in pH can influence peptide stability and the rate of degradation reactions.
  
  
• Peptide Sequence and Structure:
  The amino acid composition and the presence of specific secondary structures affect heat stability.
  
  
• Solution Conditions:
  Factors like the presence of salts, detergents, and other additives can affect peptide stability.

Practical Considerations:

• Storage:
  Dry peptides are generally stable at room temperature for short periods, but long-term storage is best at -20°C or lower, according to NIBSC.
  
  
• Handling:
  Reconstituted peptides in solution should be stored appropriately and used promptly to minimize degradation.
  
  
• Exposure to Heat:
  Peptides in solution should ideally be kept below 25°C for extended periods. Short-term exposure to room temperature may be acceptable, but prolonged exposure should be avoided, according to Intercom.

But what is the total degradationpredicted to be? If it's say 10%, that means that instead of taking 10mg of something the patient is only taking 9mg. And, everything degrades over time unless stored in cold storage. So that 2 year stash? If not properly stored, how much is it degrading?

 

[rsmith]

In my 38 years of being a DVM and using a variety of peptides for animal health throughout my career, hydrolysis and degradation has always been a concern.But, I am always learning. Heck I have been on this forum for over a year and still an Apprentice. Lol

* I realize that B-12 is not a peptide, hence why I stated peptides and “Solutions”. B12 should store it at room temperature between 59°F and 85°F otherwise high rate of degradation occurs.

Peptides, especially in solution, can be sensitive to heat, leading to degradation through various mechanisms. While short peptides may refold after heat exposure, prolonged or high-temperature exposure can cause irreversible changes like hydrolysis of peptide bonds, denaturation, and aggregation.

Mechanisms of Peptide Heat Degradation:

• Hydrolysis:
  The most common pathway for peptide bond cleavage. Heating in aqueous solutions accelerates hydrolysis, breaking the peptide chain.
  
  
• Denaturation:
  High temperatures can disrupt the secondary and tertiary structures of peptides, especially those with well-defined structures. However, many short peptides can refold upon cooling.
  
  
• Chemical Instability:
  Heat can trigger other chemical reactions, including oxidation, deamidation, racemization,and isomerization, leading to peptide degradation.
  
  
• Physical Instability:
  Changes in secondary structure, adsorption, aggregation, and precipitation can also occur due to heat exposure.

Factors Affecting Peptide Heat Stability:

• Temperature:
  Higher temperatures accelerate degradation. Short-term exposure to room temperature (up to 30°C) is generally tolerable, but prolonged exposure can cause issues.
  
  
• pH:
  Changes in pH can influence peptide stability and the rate of degradation reactions.
  
  
• Peptide Sequence and Structure:
  The amino acid composition and the presence of specific secondary structures affect heat stability.
  
  
• Solution Conditions:
  Factors like the presence of salts, detergents, and other additives can affect peptide stability.

Practical Considerations:

• Storage:
  Dry peptides are generally stable at room temperature for short periods, but long-term storage is best at -20°C or lower, according to NIBSC.
  
  
• Handling:
  Reconstituted peptides in solution should be stored appropriately and used promptly to minimize degradation.
  
  
• Exposure to Heat:
  Peptides in solution should ideally be kept below 25°C for extended periods. Short-term exposure to room temperature may be acceptable, but prolonged exposure should be avoided, according to Intercom.

Handling:
Reconstituted peptides in solution should be stored appropriately and used promptly to minimize degradation.

Yeah, I don't think so. In your 38 years as a vet, you didn't have more than a couple to learn about GLPs which clearly differ from other peptides. I have some pharmaceutical Zepbound injectors in my fridge and they contain reconstituted peptides (i.e., tirzepatide) that were purchased in May but have expiration date of March, 2027 (almost 2 years from date of purchase).

Janoshik has done some testing on Tirz in particular and his data show this particular peptide to be almost bullet proof, showing practically no degradation after 4 freeze/thaw cycles over a number of months for reconstituted Tirz.

 

[pavlovs]

I have some pharmaceutical Zepbound injectors in my fridge and they contain reconstituted peptides (i.e., tirzepatide) that were purchased in May but have expiration date of March, 2027 (almost 2 years from date of purchase).

Zepbound and Mounjaro are manufactured in strict environments and the pens are hermetically sealed. According to at least one thread in this site, we are manufacturing in our bathrooms, kitchens, dining rooms and at our desks. We're doing it using vials bought off of Alibaba and Amazon. We're buying the lyophilized from people who only take crypto and disappear in the middle of the night, overfill and underfill, add cleaning fluid and seamonkeys. As someone else said (paraphrasing a lot) Jano would tell you to go ahead and use the vial that has been sitting on your sashboard in the hot Arizona sun for three weeks and was manufactured in Denise's bathtub.

Kind of not the same.

 

[rsmith]

Zepbound and Mounjaro are manufactured in strict environments and the pens are hermetically sealed. According to at least one thread in this site, we are manufacturing in our bathrooms, kitchens, dining rooms and at our desks. We're doing it using vials bought off of Alibaba and Amazon. We're buying the lyophilized from people who only take crypto and disappear in the middle of the night, overfill and underfill, add cleaning fluid and seamonkeys. As someone else said (paraphrasing a lot) Jano would tell you to go ahead and use the vial that has been sitting on your sashboard in the hot Arizona sun for three weeks and was manufactured in Denise's bathtub.

Kind of not the same.

FWIW, I trust Jano way more than I trust EL, the latter who I consider greedy, money hungry scumbags that ultimately have exactly zero interest in my health outside of what will net them a huge, unjustifiable profit.

Per mg., the Tirz I currently have in the freezer cost me approximately 5% of the Zepbound I have in the fridge.

So yeah, kind of not the same.

 

[MsGizmo]

Zepbound and Mounjaro are manufactured in strict environments and the pens are hermetically sealed. According to at least one thread in this site, we are manufacturing in our bathrooms, kitchens, dining rooms and at our desks. We're doing it using vials bought off of Alibaba and Amazon. We're buying the lyophilized from people who only take crypto and disappear in the middle of the night, overfill and underfill, add cleaning fluid and seamonkeys. As someone else said (paraphrasing a lot) Jano would tell you to go ahead and use the vial that has been sitting on your sashboard in the hot Arizona sun for three weeks and was manufactured in Denise's bathtub.

Kind of not the same.

The FDA recalls about 4 medications a day. Just because something is packaged in a pretty bottle in a lab somewhere doesn't mean its still safe.

 

[rsmith]

The FDA recalls about 4 medications a day. Just because something is packaged in a pretty bottle in a lab somewhere doesn't mean its still safe.

Yeah, FDA recalled over 14,000 medications over the past 10 years. Hardly a confidence builder.

FDA Dashboards - Recalls

Recalls by fiscal year, classification, product type, status, etc.

datadashboard.fda.gov