Soursop and cannabis oil seller Ramonita Valentin was recently warned by the US Food and Drug Administration, or FDA, for how her company, Vacunda & Design, markets its products.
From the FDA warning letter to Valentin, we learn that V&D was the host of a multi-day inspection visit in late winter of 2016, during which agents collected labels and promotional materials. Later, Investigators also visited Valentin’s websites, including:
Agents also took a look at the company’s official Facebook page and a page that redirects to the account for SinaiPR’s supplements.
The unallowed medical claims for which Valentin was warned are associated with 2 soursop oil supplements and a cannabis oil supplement.
Sinaí Cannabis Oil:
The page that appears to have been Valentin’s official marketing page has been unpublished or deleted but the FDA alleges that it once contained photos with text promoting the cannabis oil product for medical conditions including:
- HIV and AIDS
- Alzheimer’s disease
- Depression and anxiety
- Parkinson’s disease
- ADD and ADHD
- Various skin ailments
Sinaí Soursop Oil:
Valentin’s soursop oil product was also attached to numerous claims, including one that stated it was “10,000 times more potent than chemotherapy”. It was also promoted on Facebook and through other marketing channels for medical issues including:
- High blood pressure
- Kidney and digestive issues
- Anxiety and stress
- Thyroid disease
Of course, neither the cannabis oil nor soursop oil is recognized as safe or effective for any of those conditions. The blended product is also considered “misbranded” for that same reason.
But even if they were proven effective, said the FDA, the supplements would still be “misbranded” because they’re advertised for medical conditions that the average person simply can’t self-diagnose or self-treat effectively.
Valentin and Vacunda & Design were given the normal 15 working days to address those and all the other alleged violations. As of my check this morning, it appears that Valentin’s Facebook page and one of the websites has been removed.
HealthyForLifePR.com remains up but the soursop supplements appear to have been removed.
Photo Credit: Pixabay user prasadganapule69