Kirjoittaja Aihe: B-NMN Can No Longer Be Sold as a Dietary Supplement in the US (Luettu 594 kertaa)

upamfva · 03.04.23 - 10:37

B-NMN Can No Longer Be Sold as a Dietary Supplement in the US

Beta-nicotinamide mononucleotide (β-NMN), also referred to as NMN, is a forerunner to nicotinamide adenine dinucleotide (NAD+) — a compound that repairs and protects DNA and mitochondria in the body. As people age, NAD levels decrease, which is associated with reduced energy levels, DNA damage, cognitive impairments, and inflammatory conditions.Get more news about High Quality Nmn Manufacturer Supplement,you can vist our website!

NMN is an ingredient in dietary supplements like Hello100 that research suggests may raise NAD levels in the body. Because of this, it has gained popularity as an over-the-counter anti-aging health product. As NMN dietary supplements are no longer sold in the US, NAD+ injections may become a good alternative.

The FDA had previously accepted NMN as a New Dietary Ingredient (NDI), which allowed supplement manufacturers to market it. But, on October 11, 2022, they revoked the NDI, so companies can no longer sell it in the United States.

This decision has created concern among proponents of natural supplements, practitioners, and the dietary supplement industry.
What happened to NMN?
On July 25, 2022, Inner Mongolia Kingdomway Pharmaceutical Limited voluntarily submitted an NDI for NMN because the company planned to market an NMN-containing dietary supplement.

However, on October 11, 2022, the FDA sent a letter to Kingdomway regarding the company’s NDI. The FDA document states that “NMN has been authorized for investigation as a new drug” and “may not be marketed as a dietary supplement or as a food.”

The FDA can do this because of the preclusion provision of Section 201(ff) of the Federal, Food, Drug, and Cosmetic Act. Officials created this provision to protect the commercial interests of pharmaceutical companies developing new drugs. It also prevents unscrupulous individuals or groups from bypassing the drug approval process by categorizing their ingredients as dietary supplements.
However, the FDA does not disclose when a pharmaceutical company submits an Investigational New Drug (IND) application. So, it is unclear when NMN was authorized for investigation. This led Kingdomway to question the FDA’s decision.

In a supplemental letter explaining its decision, the FDA wrote, “the evidence on which Kingdomway relies to show that Β-NMN was marketed as a dietary supplement or food before it was authorized as a new drug is too recent, not relevant, or both.”

The FDA cites February 16, 2021, as the first date on which another manufacturer could have marketed its Β-NMN product lawfully after submitting an NDI notification to the agency on December 3, 2020. However, the FDA noted that it’s unclear whether Β-NMN was actually marketed on that date.

The second timeframe the FDA points out is September 2021 — the month that Kingdomway first marketed its NMN-containing whey protein concentrate.

wellthisisme · Vastaus #1 03.06.23 - 12:38

wellthisisme · Vastaus #2 03.07.23 - 04:24

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wellthisisme · Vastaus #3 03.07.23 - 08:34

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wellthisisme · Vastaus #4 10.09.23 - 20:32

wellthisisme · Vastaus #5 11.09.23 - 04:40

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wellthisisme · Vastaus #6 03.10.23 - 03:16

wellthisisme · Vastaus #7 02.12.23 - 08:37

wellthisisme · Vastaus #8 02.02.24 - 12:08

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