FDA against Kratom Extract

FDA against Kratom Extract – Mitrasafe

Mitrasafe is a fresh addition to the Kratom extract classifications. It is a single compound Kratom extract whose launch was disapproved by the Food and Drug Administration of the United States. The reason for the FDA’s action is Mitrasafe had failed in the tests conducted to examine its dietary ingredients. The results weren’t in favor of Mitrasafe in the perception of FDA and they have called for the Ban by warning the manufacturers of Mitrasafe to not to launch their product.

FDA also pointed out the manufacturers, Industrial Chemicals; LLC/INI Botanicals that they are promoting Kratom Extract (Mitrasafe) as medicine for addiction which is actually in contrary to all of its properties and with no scientific evidence. Mitrasafe isn’t a disease treating medicine or a pain relief drug, said the officials of FDA. In addition to their statements, the FDA chief has also sent a five-page letter to the attorney claiming that the manufacturers had given misleading statements.

The crux of the five paged letter by the head of Food and Drug Administration, Scott Gottlieb, MD, is as follows:

“We have found that Mitrasafe, as publicized as a single compound extract doesn’t qualify as a dietary supplement. It is an adulterated drug, and certainly not a substitute for opium. We have also heard that the manufacturers quoting that their product is all natural and could be used in the place of morphine for the pains instigated by some acute and fatal diseases. The false claims of Kratom as addiction curing medicine and treats withdrawal symptoms are literally fear-provoking. All those unproven, unexamined, assumed and misleading statement is plainly nothing but violations. They could cause serious health complications which includes death in some cases. We are taking serious actions to protect public health from dreadful Kratom provocations. People involved in misleading statements are subjected to prosecution.”

The announcements from FDA didn’t stop there, they continued by the destruction of Kratom products by a distributor in the state of Missouri. Centers for Disease Control and Prevention’s involvement in the surveillance due to their presumptions of Salmonella Infections are linked with Kratom.

If we go through the history of Kratom, it is an herbal medication that is originated from the Southeast Asian countries like Indonesia, Malaysia etc. The momentum it has obtained in FDA and other drug enforcement sectors are mainly to its consistent growth in its sales in the region of North America. It is reported that there are around three to five million users of Kratom which is actually an unscientific and unapproved drug which is said to cure anxiety, pain, depression and addiction problems.

A statement of warning was released by the agency stating that there were many fatalities due to the consumption of Kratom within few months. There were criticisms due to the lack of proper cautionary statements from either side. There was another statement issued by the same agency in regard to the components and behavior of the Kratom extract which behave more or less in the similar way that opioids do. However many felt that the report lacked any rational and scientific value and was only successful in letting the people that Kratom and opioids are equivalent.

For every sale of products as dietary supplements, the manufacturers must see through that the product undergoes the authorized examination of new dietary ingredient notification (NDIN). A statistical survey concluded that in the recent submission to the NDIN, most of the applications, say close to 70% are rejected for the reason that the producers haven’t mentioned their chemical composition and safety details. There are some processes which have been examined and they couldn’t qualify the test as a dietary supplement.

If we go through the case of Kratom Extract, Mitrasafe, the maker had incorporated the historical data of their compositions and he had used 99% natural ingredients produced by Mitragyna Speciosa. The chemical that is used while manufacturing Kratom extract is Mitragynine (99% approx.) which is primarily bioactive of the tree and there are the huge amount of data to prove the safety of the herb.

Many scientists and freelance biologists have mentioned their doubt in the company’s claims of Kratom have 99% natural ingredients. They felt that there should be proper scientific data as proof for such claims. They also said that the company had failed to spell out the other components which compose of the other 1%.

To be specific, the federal law does not encourage such drug claims for a mere dietary supplement. It is not completely untrue that herbals do contain some ingredients which could cure pains etc. but that does not any way make an herb into a drug. The makers must produce all the necessary scientific evidence to prove their claims. It is on their part to prove their clinical safety too. If the claims are of historical data, it is certain that FDA would try hard to not approve such extracts at any cost.

Many experts felt that Mitrasafe is a dietary supplement but not a drug by any means. They had expressed their anguish in looking at such absurd claims and efforts of a company whose overemphasis is getting beyond limits day to day. The false claims also included that extract could even cure diabetes which is why the FDA is totally restrained in giving any grants to the producers of Mitrasafe.

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