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Biome Bites Ep011 - Supplements performing like drugs
FromInside Matters
ratings:
Length:
16 minutes
Released:
Jan 25, 2024
Format:
Podcast episode
Description
What are the differences between a food supplement and a drug?
There are some key differences in the regulations. And those regulations govern how they're manufactured, how they're tested, the levels of quality assurance, and also the level of evidence. that has to be generated for them to be able to be put on the market.
So drugs are regulated by competent authorities. In the UK, it's the Medicines and Healthcare Products Regulatory Agency. Food supplements are regulated by food standards agencies. In the US, interestingly, they're both governed and regulated by the same group, the FDA, Food and Drug Administration, but they're separate divisions within that very large organization that create the standards that the companies and the organizations that are manufacturing, distributing, and marketing have to adhere to.
Now, classically, there are significant price differences between drugs and food supplements, and that's driven by the level of evidence that the companies have to generate to put the products on the market. And there's much higher stringency and standards in drugs rather than foods. Drugs often fail in clinical development as well because the standards are so high.
Therefore, the drugs that are on the market are priced by the companies to be able to recoup losses from a company-wide perspective, associated with failed drugs, and also to make a significant return, typically within a patent life. of an approved drug. Back to the topic. Food supplements could be better than a drug for certain indications, and certain uses.
Timestamps:
00:00:00 Intro
00:01:46 Key differences between supplement and drug
00:03:14 Lysine
00:09:54 Quercetin
00:15:19 Melatonin
TRANSCRIPT:
Biome Bites #11
Hi everyone, it's your host Dr. James McElroy here today for another Biome Bites. This is a solo episode so you have me and only me for the entirety of this episode. Today we're going to be speaking about three food supplements that could be better than drugs. Or rather, in a parallel universe, may in fact be regulated and distributed, marketed, and prescribed as drugs.
So what are the differences between a food supplement and a drug? There are some key differences in relation to the regulations. And those regulations govern how they're manufactured, how they're tested, the levels of quality assurance, and also the level of evidence. that has to be generated for them to be able to be put on the market.
So drugs are regulated by competent authorities. In the UK, it's the Medicines and Healthcare Products Regulatory Agency. Food supplements are regulated by food standards agencies. In the US, interestingly, they're both governed and regulated by the same group, the FDA, Food and Drug Administration, but they're separate divisions within that very large organization that create the standards that the companies and the organizations that are manufacturing, distributing, and marketing have to adhere to.
Now, classically, there are significant price differences between drugs and food supplements, and that's driven by the level of evidence that the companies have to generate to put the products on the market. And there's much higher stringency and standards in drugs rather than foods. Drugs often fail in clinical development as well because the standards are so high.
Therefore, the drugs that are on the market are priced by the companies to be able to recoup losses from a company-wide perspective, associated with failed drugs, and also to make a significant return, typically within a patent life. of an approved drug. Back to the topic. Food supplements could be better than a drug for certain indications, and certain uses.
I'm going to start with something called Lysine, also known as L Lysine. Lysine is an essential amino acid. Now, there are nine essential amino acids that we're aware of for the human body. That means that they cannot be synthesized by the human body and have to be consumed, have to be generated by your diet, so you have
There are some key differences in the regulations. And those regulations govern how they're manufactured, how they're tested, the levels of quality assurance, and also the level of evidence. that has to be generated for them to be able to be put on the market.
So drugs are regulated by competent authorities. In the UK, it's the Medicines and Healthcare Products Regulatory Agency. Food supplements are regulated by food standards agencies. In the US, interestingly, they're both governed and regulated by the same group, the FDA, Food and Drug Administration, but they're separate divisions within that very large organization that create the standards that the companies and the organizations that are manufacturing, distributing, and marketing have to adhere to.
Now, classically, there are significant price differences between drugs and food supplements, and that's driven by the level of evidence that the companies have to generate to put the products on the market. And there's much higher stringency and standards in drugs rather than foods. Drugs often fail in clinical development as well because the standards are so high.
Therefore, the drugs that are on the market are priced by the companies to be able to recoup losses from a company-wide perspective, associated with failed drugs, and also to make a significant return, typically within a patent life. of an approved drug. Back to the topic. Food supplements could be better than a drug for certain indications, and certain uses.
Timestamps:
00:00:00 Intro
00:01:46 Key differences between supplement and drug
00:03:14 Lysine
00:09:54 Quercetin
00:15:19 Melatonin
TRANSCRIPT:
Biome Bites #11
Hi everyone, it's your host Dr. James McElroy here today for another Biome Bites. This is a solo episode so you have me and only me for the entirety of this episode. Today we're going to be speaking about three food supplements that could be better than drugs. Or rather, in a parallel universe, may in fact be regulated and distributed, marketed, and prescribed as drugs.
So what are the differences between a food supplement and a drug? There are some key differences in relation to the regulations. And those regulations govern how they're manufactured, how they're tested, the levels of quality assurance, and also the level of evidence. that has to be generated for them to be able to be put on the market.
So drugs are regulated by competent authorities. In the UK, it's the Medicines and Healthcare Products Regulatory Agency. Food supplements are regulated by food standards agencies. In the US, interestingly, they're both governed and regulated by the same group, the FDA, Food and Drug Administration, but they're separate divisions within that very large organization that create the standards that the companies and the organizations that are manufacturing, distributing, and marketing have to adhere to.
Now, classically, there are significant price differences between drugs and food supplements, and that's driven by the level of evidence that the companies have to generate to put the products on the market. And there's much higher stringency and standards in drugs rather than foods. Drugs often fail in clinical development as well because the standards are so high.
Therefore, the drugs that are on the market are priced by the companies to be able to recoup losses from a company-wide perspective, associated with failed drugs, and also to make a significant return, typically within a patent life. of an approved drug. Back to the topic. Food supplements could be better than a drug for certain indications, and certain uses.
I'm going to start with something called Lysine, also known as L Lysine. Lysine is an essential amino acid. Now, there are nine essential amino acids that we're aware of for the human body. That means that they cannot be synthesized by the human body and have to be consumed, have to be generated by your diet, so you have
Released:
Jan 25, 2024
Format:
Podcast episode
Titles in the series (44)
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