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Alive by Nature, now Alive by Science; FDA Investigation #1

alive by science FDA Crime

federal food, drug, and cosmetic act.

Alive by Nature, now Alive by Science, were written to on the 25th of July 2019, by the FDA, where the the FDA explained statements on their website violate the Federal Food, Drug, and Cosmetic Act.

the fda letter

FDA letter to Alive by Nature, now Alive by Science

The FDA letter to Alive by Nature, now Alive by Science reads: 

Dear Bryan Nettles: 

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at www.alivebynature.com [now https://alivebyscience.com] in May 2019 and has found that you take orders there for: 

claims and statements 

Alive by Science claims on website

Various claims and statements made on your website and/or in other labeling establish that these products are drugs as defined in 21 U.S.C. § 321(g)(1)(B) because they are intended for the treatment, cure, mitigation, or prevention of disease. 

For example, your website recommends or suggests the use of (it then lists the eight types of NMN that Alive by Nature, now Alive by Science sells) to treat, mitigate or prevent various cardiovascular diseases, fatty liver disease, alcoholic liver disease, Parkinson’s disease, Alzheimer’s disease, diabetes, various cancers, alcohol addiction, drug addiction, brain damage, and multiple sclerosis. 

As explained further below, the introduction of these products into interstate commerce for such uses violates the Federal Food, Drug, and Cosmetic Act. 

These products are also new drugs as defined under 21 U.S.C. § 321(p) because they are not generally recognized as safe and effective for the uses recommended or suggested in their labeling. Before a new drug may be marketed or otherwise introduced into interstate commerce, it must be approved by the FDA on the basis of scientific data demonstrating that the drug is safe and effective under the conditions of use in its labeling. See 21 U.S.C. §§ 355(a) and 331(d). Your drug products do not have FDA-approved applications as required by 21 U.S.C. § 355.

saying ‘did’ and not ‘may’

Alive by Science maybe misleading?

So, it appears that where most companies selling NMN state that taking NMN ‘may’ have a positive effect in regard to these age related diseases Alive by Nature, now Alive by Science were saying their products ‘did’ cure, prevent etc. or maybe they didn’t emphasize the fact that NMN had only been tested on animals?

advice to alive by nature, now alive by science 

Alive by Science advice from the FDA

We advise you to review all materials through which you communicate to consumers the intended uses of your products, and to either submit a New Drug Application (NDA) for products intended for use in treating, curing, mitigating, diagnosing, or preventing a disease or, alternatively, remove all statements indicating that your products are intended for such uses. 

This would include reviewing your websites, product labels, catalogs, brochures, flyers, package inserts, audio and video, e-commerce and social media accounts you operate (e.g., Amazon, eBay, Facebook and Twitter accounts), as well as any other promotional materials, and removing product claims, consumer testimonials, metatags, and anything else that states or implies that your products are useful in treating, curing, mitigating, diagnosing, or preventing diseases. 

So, the FDA seem to be advising pretty much purge anything that Alive by Nature, now Alive by Science owns that states cure, treat, mitigate or prevent disease. 

fda deadline 

The Alive by Science FDA deadline

Within 30 calendar days of the date of this letter, please correct the violations described in this letter and notify the FDA that the violations have been corrected.  

fda statement on non-compliance

Alive by Science have Products Illegally Marketed For Serious Diseases

After 30 days from the date of this letter (25th of July 2019), if your website(s) or other labeling continue to demonstrate that your products are intended to treat, cure, mitigate, or prevent diseases, the name of your firm and this letter will be posted on the FDA web-page for Products Illegally Marketed For Serious Diseases. 

This letter is not intended to be an all-inclusive review of your website(s) or a list of all violations of law that exist in connection with your products, your website(s) and other product labeling, or at your facilities. 

The FDA expects you to take the necessary steps to ensure that all your products comply with the laws and regulations enforced by FDA. 

Sincerely, 

U.S. Food and Drug Administration

conclusion

alive by science, what do you think?

So, this may simply have been an oversight by Alive by Nature, now Alive by Science in claiming that their NMN products can treat, cure, mitigate, or prevent diseases. 

But, the tone of the FDA’s letter leans more to Alive by Nature’s, now Alive by Science’s content being misleading by design, let me know below what you think.

So, I looked at Alive by Nature, now Alive by Science website, and I can’t see any obvious statements that claim their products treat, cure, mitigate, or prevent diseases. So it looks like they have removed those statements.  

However, it appears that Alive by Nature, now Alive by Science didn’t comply in time, they are now listed on the FDA webpage for Products Illegally Marketed for Serious Diseases.  

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