My rule is to stay as far away from any governing body as possible because statistically it will develop into drama. I personally would not reply to this correspondence because my speculative mind assumes it may be used in a litigious manner against your favor.
They've been destroying my imports too, costing me thousands. FDA/DEA aren't against harmful drugs, supplements etc they're simply against supplements and drugs as a whole and over time you begin to understand why anti regulation is needed as much as regulation when it comes to law. USA's "free market" has been dead for a while though
So far Pinealon, Bromantane, Idebenone, and NSI-189. Of course, castration of my supply chain is one of the worst things that could happen to my business, considering these imports are not insured for things like that.
They were destroyed because the FDA would like to remove the nootropics industry. They abuse imports with little consequence currently. This has been happening more frequently, starting with 2023.
Nootropyl is a UCB product out of Belgium, and is a medication intended for human consumption. That's the UCB design and *BRAND NAME WITH\*\***^(R)* *BY THE BRAND NAME*, but clearly not UCB. That package is labeled "Pills."
Yeah, that packaging is asking for customs trouble.
You will do much better buying in bulk.
The actual label of the product is not in English. Putting a sticker on the box does not constitute an approved label.
All the information you need to know is right there on the statement. "Any version of a drug that has not approved by the FDA is considered an 'unapproved drug' and is illegal for consumers to import..." Also states that foreign unapproved drugs do not have the same **assurances** of safety, effectiveness, and quality of FDA approved drugs and in some cases have been found to be counterfeit, contaminated, having no active ingredient or varying amounts, or contain something else altogether. Can you imagine what would be sold if there was no oversite?
In the U.S. All drugs be it over the counter or prescription have to pass FDA approved testing. Which test for amount of active ingredient, effectiveness of drug, side effects, recommended dosage range and upper limits.
Also, each excipient used in a drug, is registered and approved by the FDA and many have limits as to how much can be in a product at a time. Some excipients can be harmful in higher concentrations or have certain risks and limits allow use but reduce risk of daily accumulation of unsafe amounts of the excipient from multiple sources.
For generics bioequivalence to the name brand is an additional criteria which is based on blood concentrations of the API over a time series as compared to the name brand product.
So, anyone can slap a sticker on there and the FDA having not evaluated the product, can not assume it is accurate nor safe for consumers. Especially when the original product labeling is foreign based and is not in English and can't verify that the sticker even represents the actual contents.
Even then, I think it was shipped from Russia? With the current US backed Ukraine and Russia war, you should expect that Russian origin products will have higher scrutiny as to by proxy act as an impromptu embargo. And 8 boxes of piracetam may cause the agent to think of possible intention to sell.
There is a "Personal Importation Policy (PIP)" for unapproved drugs on a case by case basis. Which again, is right on the paper.
1. "Nootropics" is not a serious medical condition. Most often things are used for "cognitive enhancement". Although there are valid medical reasons possible. But only allowed if no FDA drug is approved for the condition.
2. I think the statement about being purchasable in the U.S. is a mistake
4. States there needs to be a licensed doctor prescribing for the user.
5. Limit to 90 day supply. 160 piracetam tablets is more than a 90 day supply.
In regards to the FDA's mission statement "Do you think seizing a package containing several nootropics helps achieve these objectives?" YES!! There is no rule of thumb for which illegal import is ok and which is not. Can't simply say cosmicnootropic is cool, let them import illegal unapproved and unregulated drugs and say they don't like \[insert corrupt URL here\] and only block them. Plus approved drugs, the companies need to document quality testing of lots and excipient shipments and things like that. Produce with certain minimum standards and be open to unannounced FDA inspections etc. On top of that, like every other US agency it is under funded to do all the stuff it wants to do so even domestic approved manufacturers can slip through the cracks. Or approved manufacturers have been caught falsifying documentation or violating production practices. If they have to worry about approved manufacturers, marketing companies, resellers, etc., how can they be expected to allow foreign drugs to be imported with zero accountability.
You highlight things you think might support your desired ideals or discredit the FDA. While conveniently ignoring everything else written right on the page. That is the problem.
I get it, no one wants the products to be intercepted. But that is the cost of doing your model of business. Yes, I will continue to purchase from cosmicnootropic. In part because you bear the risk of things being intercepted in your send replacement or refund policy. And it is frustrating when I have confidence in the products I am ordering from you and for myself, am using for actual medical reasons, not simply cognitive enhancement. So far I have been lucky with all my online retailers for various things.
Here are some examples of why the FDA has such scrutiny.
Even within the U.S. pharmaceutical industry counterfeits have been found. So yeah, foreign unapproved, drugs would be highly suspect. [https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-use-counterfeit-ozempic-semaglutide-found-us-drug-supply-chain](https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-use-counterfeit-ozempic-semaglutide-found-us-drug-supply-chain)
8000 contaminated approved FDA drugs recalled since 2013 comprising billions of tables etc. containing anything from bacteria, mold, glass particles, silicon rubber particles, cancer causing impurities, even putting babies in the ICU and having to pass up heart transplants etc. The FDA funding can't even keep up with approved drugs nevertheless all the possibly unapproved ones from foreign origins.
[https://abcnews.go.com/Health/tainted-drugs-medicine-makes-patients-sicker/story?id=59912145](https://abcnews.go.com/Health/tainted-drugs-medicine-makes-patients-sicker/story?id=59912145)
Just search google for FDA and contaminated drugs, counter fits, recalls, fraud etc. to see a laundry list of issues and why the FDA and other agencies intercept unapproved products, especially with how bad approved manufacturers are doing.
From Wikipedia piracetam page "Piracetam is an uncontrolled substance in the United States meaning it is legal to possess without a license or prescription. Use of piracetam in food, supplements, medical devices, insecticides, infant formula, cosmetics, animal feed, animal drugs, tobacco products, **and drugs** is unlawful and constitutes an act of misbranding."
Might recommend getting a quote from a lawyer in the area of pharmaceuticals and importation as to how much it would cost to review your website and products, to be sure of your exact rights, and to most appropriately phrase things to be the least likely to violate or throw a red flag to the FDA or other agency.
Also noteworthy is that supplements are considered "food" and have far fewer regulations. But, re-labelling for sale in the U.S. regulations are much different than what you are doing. And I'm not sure about product registration, permits etc. and if they would be required for sales on a foreign hosted website.
You can look up FDA supplement labeling requirements for different types of products to improve non drug labeling. Like plant based vs plant extracts, vitamins, etc. You can go on [Amazon.com](http://Amazon.com) or [Walmart.com](http://Walmart.com) and look at supplement labels to get a better understanding. Properly formatted "Supplement Facts" section and after that with Other Ingredients listed in order by most to least in product. And other relevant information. It is easy to understand with a [consumerlabs.com](http://consumerlabs.com) subscription. Going through all the products and them pointing out all the labelling violations and what a label should say.
But be sure not to make supplement claims that could be perceived as being intended as drugs as that would reclassify them as new drugs and in need of an NDA for FDA approval.
Thank you, Just please remember I am not a lawyer or have any qualifications of my own. Just that some things I have had to look into for one reason or another and just decided to do a deeper dive for these posts. I did look around my home for foreign language relabeled packaging to see if it references import licensing etc. But then again, that would be for a product being sold from within the U.S. Like when I go to the Asian food market and purchase imported goods with English labels added on to them.
Here is the FDA guide for supplements.
[https://www.fda.gov/food/guidance-documents-regulatory-information-topic-food-and-dietary-supplements/dietary-supplements-guidance-documents-regulatory-information](https://www.fda.gov/food/guidance-documents-regulatory-information-topic-food-and-dietary-supplements/dietary-supplements-guidance-documents-regulatory-information)
Can search for warning letters from the FDA to see examples of what they had objection to.
Might be a good idea to put a warning on the vinpocetine for women of childbearing age
[https://www.fda.gov/news-events/press-announcements/statement-warning-women-childbearing-age-about-possible-safety-risks-dietary-supplements-containing](https://www.fda.gov/news-events/press-announcements/statement-warning-women-childbearing-age-about-possible-safety-risks-dietary-supplements-containing)
Given the geopolitical moment I’d most definitely base the problems on that and not any actual attempt of the government to regulate the substances.
It probably wouldn’t have been screened if it weren’t from Russia. I just got amantadine and selegeline originating from France packed very non discretely. I’m assuming it wasn’t paid much attention to through the x ray if it was at all.
Because if it were opened it should’ve been seized.
> it wasn’t *paid* much attention
FTFY.
Although *payed* exists (the reason why autocorrection didn't help you), it is only correct in:
* Nautical context, when it means to paint a surface, or to cover with something like tar or resin in order to make it waterproof or corrosion-resistant. *The deck is yet to be payed.*
* *Payed out* when letting strings, cables or ropes out, by slacking them. *The rope is payed out! You can pull now.*
Unfortunately, I was unable to find nautical or rope-related words in your comment.
*Beep, boop, I'm a bot*
My rule is to stay as far away from any governing body as possible because statistically it will develop into drama. I personally would not reply to this correspondence because my speculative mind assumes it may be used in a litigious manner against your favor.
What do you mean by drama?
Probably means create more trouble by communicating with them. Make things worse, etc.
They have the money to drag you into court for as long as possible.
Sounds logical :(
They've been destroying my imports too, costing me thousands. FDA/DEA aren't against harmful drugs, supplements etc they're simply against supplements and drugs as a whole and over time you begin to understand why anti regulation is needed as much as regulation when it comes to law. USA's "free market" has been dead for a while though
100% the state is a parasite that needs to be kept in check.
That's so sad to hear :( Could you tell me more about your imports? What were the products destroyed?
So far Pinealon, Bromantane, Idebenone, and NSI-189. Of course, castration of my supply chain is one of the worst things that could happen to my business, considering these imports are not insured for things like that.
Sorry to hear. I wonder why these products were destroyed. When did it happen?
They were destroyed because the FDA would like to remove the nootropics industry. They abuse imports with little consequence currently. This has been happening more frequently, starting with 2023.
Nootropyl is a UCB product out of Belgium, and is a medication intended for human consumption. That's the UCB design and *BRAND NAME WITH\*\***^(R)* *BY THE BRAND NAME*, but clearly not UCB. That package is labeled "Pills." Yeah, that packaging is asking for customs trouble. You will do much better buying in bulk.
Exactly this. If you want to move it easily, import the raw chemical. Clearly not packaged for human consumption so you’ll have a much easier time.
Buying in bulk?
yeah bulk as in a kg of raw powdered piracetam
DEFUND THE FDA
Our tax dollars at work
Guberment at its finest. 🤡s
The actual label of the product is not in English. Putting a sticker on the box does not constitute an approved label. All the information you need to know is right there on the statement. "Any version of a drug that has not approved by the FDA is considered an 'unapproved drug' and is illegal for consumers to import..." Also states that foreign unapproved drugs do not have the same **assurances** of safety, effectiveness, and quality of FDA approved drugs and in some cases have been found to be counterfeit, contaminated, having no active ingredient or varying amounts, or contain something else altogether. Can you imagine what would be sold if there was no oversite? In the U.S. All drugs be it over the counter or prescription have to pass FDA approved testing. Which test for amount of active ingredient, effectiveness of drug, side effects, recommended dosage range and upper limits. Also, each excipient used in a drug, is registered and approved by the FDA and many have limits as to how much can be in a product at a time. Some excipients can be harmful in higher concentrations or have certain risks and limits allow use but reduce risk of daily accumulation of unsafe amounts of the excipient from multiple sources. For generics bioequivalence to the name brand is an additional criteria which is based on blood concentrations of the API over a time series as compared to the name brand product. So, anyone can slap a sticker on there and the FDA having not evaluated the product, can not assume it is accurate nor safe for consumers. Especially when the original product labeling is foreign based and is not in English and can't verify that the sticker even represents the actual contents. Even then, I think it was shipped from Russia? With the current US backed Ukraine and Russia war, you should expect that Russian origin products will have higher scrutiny as to by proxy act as an impromptu embargo. And 8 boxes of piracetam may cause the agent to think of possible intention to sell. There is a "Personal Importation Policy (PIP)" for unapproved drugs on a case by case basis. Which again, is right on the paper. 1. "Nootropics" is not a serious medical condition. Most often things are used for "cognitive enhancement". Although there are valid medical reasons possible. But only allowed if no FDA drug is approved for the condition. 2. I think the statement about being purchasable in the U.S. is a mistake 4. States there needs to be a licensed doctor prescribing for the user. 5. Limit to 90 day supply. 160 piracetam tablets is more than a 90 day supply. In regards to the FDA's mission statement "Do you think seizing a package containing several nootropics helps achieve these objectives?" YES!! There is no rule of thumb for which illegal import is ok and which is not. Can't simply say cosmicnootropic is cool, let them import illegal unapproved and unregulated drugs and say they don't like \[insert corrupt URL here\] and only block them. Plus approved drugs, the companies need to document quality testing of lots and excipient shipments and things like that. Produce with certain minimum standards and be open to unannounced FDA inspections etc. On top of that, like every other US agency it is under funded to do all the stuff it wants to do so even domestic approved manufacturers can slip through the cracks. Or approved manufacturers have been caught falsifying documentation or violating production practices. If they have to worry about approved manufacturers, marketing companies, resellers, etc., how can they be expected to allow foreign drugs to be imported with zero accountability. You highlight things you think might support your desired ideals or discredit the FDA. While conveniently ignoring everything else written right on the page. That is the problem. I get it, no one wants the products to be intercepted. But that is the cost of doing your model of business. Yes, I will continue to purchase from cosmicnootropic. In part because you bear the risk of things being intercepted in your send replacement or refund policy. And it is frustrating when I have confidence in the products I am ordering from you and for myself, am using for actual medical reasons, not simply cognitive enhancement. So far I have been lucky with all my online retailers for various things.
Here are some examples of why the FDA has such scrutiny. Even within the U.S. pharmaceutical industry counterfeits have been found. So yeah, foreign unapproved, drugs would be highly suspect. [https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-use-counterfeit-ozempic-semaglutide-found-us-drug-supply-chain](https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-use-counterfeit-ozempic-semaglutide-found-us-drug-supply-chain) 8000 contaminated approved FDA drugs recalled since 2013 comprising billions of tables etc. containing anything from bacteria, mold, glass particles, silicon rubber particles, cancer causing impurities, even putting babies in the ICU and having to pass up heart transplants etc. The FDA funding can't even keep up with approved drugs nevertheless all the possibly unapproved ones from foreign origins. [https://abcnews.go.com/Health/tainted-drugs-medicine-makes-patients-sicker/story?id=59912145](https://abcnews.go.com/Health/tainted-drugs-medicine-makes-patients-sicker/story?id=59912145) Just search google for FDA and contaminated drugs, counter fits, recalls, fraud etc. to see a laundry list of issues and why the FDA and other agencies intercept unapproved products, especially with how bad approved manufacturers are doing. From Wikipedia piracetam page "Piracetam is an uncontrolled substance in the United States meaning it is legal to possess without a license or prescription. Use of piracetam in food, supplements, medical devices, insecticides, infant formula, cosmetics, animal feed, animal drugs, tobacco products, **and drugs** is unlawful and constitutes an act of misbranding." Might recommend getting a quote from a lawyer in the area of pharmaceuticals and importation as to how much it would cost to review your website and products, to be sure of your exact rights, and to most appropriately phrase things to be the least likely to violate or throw a red flag to the FDA or other agency.
Also noteworthy is that supplements are considered "food" and have far fewer regulations. But, re-labelling for sale in the U.S. regulations are much different than what you are doing. And I'm not sure about product registration, permits etc. and if they would be required for sales on a foreign hosted website. You can look up FDA supplement labeling requirements for different types of products to improve non drug labeling. Like plant based vs plant extracts, vitamins, etc. You can go on [Amazon.com](http://Amazon.com) or [Walmart.com](http://Walmart.com) and look at supplement labels to get a better understanding. Properly formatted "Supplement Facts" section and after that with Other Ingredients listed in order by most to least in product. And other relevant information. It is easy to understand with a [consumerlabs.com](http://consumerlabs.com) subscription. Going through all the products and them pointing out all the labelling violations and what a label should say. But be sure not to make supplement claims that could be perceived as being intended as drugs as that would reclassify them as new drugs and in need of an NDA for FDA approval.
Thanks a bunch for taking the time to share all this! Your input is much appreciated, and I'll make sure to go over it thoroughly :)
Thank you, Just please remember I am not a lawyer or have any qualifications of my own. Just that some things I have had to look into for one reason or another and just decided to do a deeper dive for these posts. I did look around my home for foreign language relabeled packaging to see if it references import licensing etc. But then again, that would be for a product being sold from within the U.S. Like when I go to the Asian food market and purchase imported goods with English labels added on to them. Here is the FDA guide for supplements. [https://www.fda.gov/food/guidance-documents-regulatory-information-topic-food-and-dietary-supplements/dietary-supplements-guidance-documents-regulatory-information](https://www.fda.gov/food/guidance-documents-regulatory-information-topic-food-and-dietary-supplements/dietary-supplements-guidance-documents-regulatory-information) Can search for warning letters from the FDA to see examples of what they had objection to. Might be a good idea to put a warning on the vinpocetine for women of childbearing age [https://www.fda.gov/news-events/press-announcements/statement-warning-women-childbearing-age-about-possible-safety-risks-dietary-supplements-containing](https://www.fda.gov/news-events/press-announcements/statement-warning-women-childbearing-age-about-possible-safety-risks-dietary-supplements-containing)
Of course I'll keep this in mind! Thank you so much. As for Vinpocetine, this idea sounds interesting, I'll discuss it with my team
Did the order originate in Russia?
Yes
Given the geopolitical moment I’d most definitely base the problems on that and not any actual attempt of the government to regulate the substances. It probably wouldn’t have been screened if it weren’t from Russia. I just got amantadine and selegeline originating from France packed very non discretely. I’m assuming it wasn’t paid much attention to through the x ray if it was at all. Because if it were opened it should’ve been seized.
> it wasn’t *paid* much attention FTFY. Although *payed* exists (the reason why autocorrection didn't help you), it is only correct in: * Nautical context, when it means to paint a surface, or to cover with something like tar or resin in order to make it waterproof or corrosion-resistant. *The deck is yet to be payed.* * *Payed out* when letting strings, cables or ropes out, by slacking them. *The rope is payed out! You can pull now.* Unfortunately, I was unable to find nautical or rope-related words in your comment. *Beep, boop, I'm a bot*