# FDA WARNING_LETTER - 1st Phorm LLC - March 31, 2021

Source: https://www.keypedia.com/records/warning_letter/1st-phorm-llc/34dd27a3-92c9-403e-bef4-4d2a32db4737

> FDA WARNING_LETTER for 1st Phorm LLC on March 31, 2021. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: 1st Phorm LLC
- Inspection Date: 2021-03-31
- Product Type: Food
- Office Name: Office of Human and Animal Food West Division II
- Summary: The FDA issued a Warning Letter to 1st Phorm LLC on July 29, 2021, following a March 2021 review of their website, www.1stphorm.com. The review identified serious violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, the products Whole Heart Cardiovascular Health Formula and Full-Mega Omega-3 Fish Oil were deemed "unapproved new drugs" and "misbranded drugs." Website claims for these products, such as those found on their respective product pages, established their intent for use in the cure, mitigation, treatment, or prevention of disease, classifying them as drugs under section 201(g)(1)(B) of the Act. Since they are not generally recognized as safe and effective for these uses, they are considered "new drugs" under section 201(p) and require prior FDA approval, which they lack. Furthermore, these products are misbranded under section 502(f)(1) because they lack adequate directions for use by a layperson, as their intended uses require supervision by a licensed practitioner.

Additionally, the products MegaWatt V2, Thyro-Drive, 1-Db Overdrive Fastpack, 1-Db Goddess, and 1-Db Overdrive & Thyro-Drive were found to be "adulterated dietary supplements" under section 413(a) of the Act. These products

## Related Officers

- [District Director](https://www.keypedia.com/people/latonya-mitchell/433fa355-5a9b-4723-876c-782d1ca5737d)
- [Christopher M. Klein](https://www.keypedia.com/people/christopher-m-klein/759ed06b-6416-4238-85ec-e1e8c7106321)
- [Sal Frisella](https://www.keypedia.com/people/sal-frisella/fcb5633d-8ff9-4806-9319-c6999126bb72)

Company: https://www.keypedia.com/companies/1st-phorm-llc/2bdb8bb8-de16-4204-a679-affe70eb2afd

Office: https://www.keypedia.com/offices/office-of-human-and-animal-food-west-division-ii/5966c263-9d27-4d22-8c31-6c72f83e0767