1st Phorm LLC
FDA issued a warning letter to 1st Phorm LLC (CEO Andrew Frisella) on July 29, 2021, after reviewing the company's website and finding that two products — Whole Heart Cardiovascular Health Formula and Full-Mega Omega-3 Fish Oil — were marketed with disease-treatment claims that rendered them unapproved new drugs and misbranded drugs under the FD&C Act. Additionally, five 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 because they contained hordenine, a new dietary ingredient for which no required safety notification had been submitted to FDA. The letter demands written corrective action within 15 working days and warns that failure to comply may result in seizure and injunction.
Flagged claims (11)
Regular use of Whole Heart can revamp your body's blood flow and help decrease cholesterol production.
IMPROVE LDL/HDL Ratio
[The natural substances in Whole Heart are also key components in helping treat arthritis and other common issues like acne and skin-diseases.
REDUCE Inflammation
MODERATE Cholesterol Levels
Studies on fish oils rich in both EPA and DHA have shown they help with lowering blood pressure, reducing triglyceride levels, lowering "bad" cholesterol (LDL) levels . . ..
Omega-3 fish oils rich in EPA and DHA have been shown to improve your body's natural anti-inflammatory response. They can also be used to reverse the symptoms of many conditions that are triggered by inflammation, such as asthma and psoriasis. Help boost your body's natural anti-inflammatory response . . . by supplementing daily with Full-Mega.
We formulated Whole Heart to help decrease unhealthy levels of LDL cholesterol.
The results of clinical studies have shown that they can be used to treat symptoms of ADHD as well as to combat symptoms of depression.
Whole Heart is a pharmaceutical-grade blend of ingredients designed to . . . combat cardiovascular disease and heart attacks.
Narrowing of the arteries increases resistance can lead to high blood pressure, the silent killer. To help remedy this, the ingredients in Whole Heart were carefully chosen because of their ability to lower inflammation and prevent the breakdown of nitric oxide, which can result in decreased blood pressure levels.
Required actions (2)
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so.
Failure to adequately address this matter may result in legal action, including, without limitation, seizure and injunction.
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