A recently published medical case report claims a patient developed acute liver failure after taking Provitalize, a natural menopause supplement. While such a report may raise understandable concern, the purpose of this article is to provide factual context, clarify the safety profile of Provitalize’s ingredients, and outline our regulatory position and response to this report.
The Claim: Liver Failure Allegedly Linked to Provitalize
The article presents a single case of liver injury and suggests a potential link to Provitalize. However:
- To date, we have not received any direct or indirect reports of this incident from consumers, medical professionals, or regulatory authorities such as the FDA.
- There is no clinical or mechanistic evidence presented in the article that supports a causative link.
- The report itself states a lack of well-defined mechanisms for turmeric toxicity.
What’s in Provitalize?
Here’s a breakdown of the supplement’s formula (per 2-capsule serving):
| Ingredient | Amount | Known Safety Profile |
|---|---|---|
| Proprietary Synbiotic Blend | 400 mg | L. gasseri, B. breve, B. lactis with FOS prebiotics — Prebiotics are classified as GRAS (Generally Recognized As Safe) by the FDA while the probiotic strains have passed genomic safety evaluation. |
| Turmeric Root Extract | 350 mg | The World Health Organization (WHO) recommends up to 1.5–3 g/day while clinical studies support up to 8 g/day. |
| Moringa Leaf (7:1 Extract) | 350 mg | No adverse effects in human trials. |
| Curry Leaf (Helichrysum) | 150 mg | No evidence of liver toxicity in clinical literature. |
| Sunflower-Derived Lecithin | 50 mg | Common food additive found in many products such as chocolate bars, candies, pastries, and vegan products. Classified as GRAS by the FDA. |
| Black Pepper Fruit Extract (BioPerine®) | 3 mg | Patented ingredient and classified as GRAS by the FDA. |
Turmeric: Liver Risk or Safe Anti-Inflammatory?
Turmeric is a bright yellow spice commonly used in curry dishes. Its active ingredient, curcumin, is widely recognized for its anti-inflammatory and antioxidant properties. Many people consume turmeric daily in foods or as supplements for joint pain, arthritis, or general inflammation.
The report speculates turmeric (Curcuma longa) might be responsible for the adverse outcome. However, research shows:
- Clinical data confirms safety up to 4 to 8 grams per day.
- Provitalize contains only 350 mg per day, far below WHO’s recommended intake range.
- Turmeric is classified as safe by: FDA (Generally Recognized as Safe), EFSA (European Food Safety Authority), EMA (European Medicines Agency).
Mild side effects such as nausea or abdominal discomfort have been observed in rare cases, but severe liver damage has not been established.
What About Moringa and Curry Leaf?
- The toxicity studies cited in the report are based on animal models, which cannot be extrapolated to humans.
- Moringa oleifera has a robust history of safe use in both traditional medicine and modern supplements. No adverse effects have been observed in human trials.
- Curry leaf (Helichrysum italicum) has no established association with liver injury and is commonly used in herbal formulations and cooking.
Do Probiotics Harm the Liver?
The probiotic strains in Provitalize, Lactobacillus gasseri, Bifidobacterium breve, and B. animalis subsp. lactis, are:
- Recognized as safe and effective in human gut health studies.
- Used in food and supplements globally.
- Do not produce harmful substances that could damage the liver.
- Typically associated only with mild digestive symptoms, like gas or bloating.
Supporting Ingredients: Lecithin and BioPerine®
- Lecithin (from sunflower) is a phospholipid widely used in foods and pharmaceuticals. It has a long-standing safety record.
- BioPerine®, a black pepper extract, is included at 3 mg. It is a patented, GRAS-certified ingredient used to improve nutrient absorption.
Regulatory Oversight and Product Safety
We maintain rigorous safety oversight throughout product development and post-market monitoring. Our practices include:
- Ongoing pharmacovigilance and internal safety reviews.
- Manufacturing in compliance with GMP and FDA quality standards.
- Open communication with regulatory authorities.
If a serious adverse event were confirmed, we would immediately report it to the FDA as required by regulation.
What Are Real Customers Saying?
Provitalize has been used by millions of customers worldwide, many of whom share their feedback publicly. On Trustpilot, BB Company has earned a 4.5+ star average rating across hundreds of verified reviews.
"I feel more energized, my hot flashes are gone, and I haven’t had any side effects."
"It really helped with my gut health and bloating. I love this product!"
Importantly, there is no pattern of serious adverse events, such as liver-related complaints, among verified reviews—further supporting the product’s real-world safety record.
About Scientific Publications and Evidence
You might wonder how to interpret this case report on PubMed. Let's explore what this means in context.
Understanding PubMed's Role
PubMed is a respected scientific database managed by the U.S. National Library of Medicine. As the world's leading biomedical literature repository, it hosts millions of peer-reviewed scientific articles from prestigious journals worldwide.
While PubMed maintains high standards for indexed journals, individual articles can vary in their level of evidence:
- Some are large clinical trials with extensive data
- Others are preliminary findings or individual case observations
- Each type of study serves different scientific purposes
About This Case Report
The article discussing Provitalize is a case report—an important type of medical publication that documents individual clinical observations. While valuable for identifying potential areas for further research, case reports have specific limitations:
- They focus on single cases rather than larger population studies
- They often serve as starting points for scientific investigation
- They require additional research to confirm any suggested associations
In this particular case report, the authors note a possible connection with turmeric, while acknowledging:
- The need for further investigation
- The presence of other potential factors
- The importance of additional clinical evidence
The Value of the Scientific Process
Scientific understanding develops through multiple studies and various types of evidence. While this case report contributes to the scientific discussion, it represents just one piece of a larger picture.
Good science requires both preliminary observations and comprehensive research to establish reliable conclusions.
This is why regulatory bodies consider multiple sources of evidence when evaluating product safety — including clinical trials, population studies, and post-market surveillance data.
Final Thoughts: Speculative Claims vs. Scientific Evidence
The case report offers a hypothetical association between Provitalize and liver injury, without presenting definitive causal evidence. Our position is supported by:
- Decades of safe turmeric usage in clinical research
- Absence of adverse reactions in our post-market surveillance
- Ingredient safety confirmed by globally recognized regulatory bodies, including the FDA, EFSA, and EMA
As of today, Provitalize remains a safe supplement when used as directed. We stand by the formulation’s integrity, scientific grounding, and regulatory compliance.
💬 What You Can Do
If you or someone you know experiences symptoms while taking any supplement:
- Discontinue use immediately
- Seek medical advice
- Report the event to us or directly to the FDA’s MedWatch Program
- Or contact our Customer Service Team
We treat every concern with seriousness and are committed to ensuring the health and trust of our customers.