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 in response to this report.

The article presents a single case of liver injury and suggests a potential link to Provitalize. However:

• Regarding this incident, we have not been contacted directlyby consumers, medical professionals, or regulatory authorities (such as the FDA)
• There is no confirmed mechanistic evidence presented in the article that supports a causative link for turmeric or other ingredients in Provitalize
• Individual (idiosyncratic) reactions to liver injury can be completely independent from a product or ingredient’s safety profile
• The rare incidents of liver injury associated with turmeric or other ingredients mentioned in this article suggest that the consumer could have experienced an idiosyncratic reaction that was unrelated to Provitalize’s safety or quality
• According to the article’s list of testing performed, the consumer was not evaluated for a hypersensitivity reaction, which is a potential rare cause for acute liver injury and typically unrelated to product/ingredient safety
• The consumer presented with several known risks for liver injury, such as age, gender, possible postmenopausal metabolic compromise, potentially overweight, and alcohol consumption
• It is unknown if the consumer experienced any relevant signs or symptoms prior to her consumption of Provitalize
• It is unknown if the consumer took other non-prescription products for her pre-existing health concerns (asthma, weight loss, and menopause symptoms) that could have caused or contributed to the incident
• The consumer took less than the recommended dose of Provitalize, which also means she consumed amounts of turmeric and curry that are well below amounts shown in research to be safe and well tolerated

Here’s a breakdown of the supplement’s formula (per 2-capsule serving):

Turmeric is a bright yellow spice commonly used in curry dishes, and its active ingredient, curcumin, is known for its anti-inflammatory and antioxidant properties.

Many people consume foods containing turmeric daily or take turmeric supplements to support healthy joints and general wellness.

The report speculates turmeric (Curcuma longa) might be responsible for the adverse outcome. Here's what research tells us about turmeric's safety:

• Clinical data confirm safety up to 4–8 grams per day
• Provitalize contains only 350 mg per day—far below WHO’s recommended intake range
• Turmeric is classified as safe by the FDA (Generally Recognized as Safe)

Mild side effects such as nausea or abdominal discomfort have been observed in rare cases, but severe liver damage (direct hepatoxicity) has not been established as causally related to turmeric’s inherent safety profile. 

In very rare cases, a consumer may have a pre-existing genetic predisposition to react to a particular substance (similar to how food allergies are unique to the individual and not an indication that a food is unsafe).

Unlike a food allergy, however, these particular types of hypersensitivity reactions can present the same way as certain types of liver toxicity. Turmeric, for example, may be associated with this type of reaction in individuals carrying the HLA-B*35:01 gene.

Again, this is not typically associated with the ingredient’s safety and quality. It is unique to the individual’s rare genetically-related sensitivity to a specific ingredient and can occur with the consumption of very low amounts of an ingredient. 

Unfortunately, the authors of the published case report associated with Provitalize, did not mention that genetic profiling for HLA-B*35:01 was performed as a diagnostic tool. 

Therefore, it is possible that the consumer had this unique sensitivity and her reaction was not related to the general safety of turmeric or other ingredients in Provitalize.

• The toxicity studies cited in the report are based on animal models, which cannot be extrapolated to humans.
• Moringa oleifera has been studied in multiple human clinical trials with no adverse effects, and has a robust history of studies and safe use in both traditional medicine and modern supplements.
• Curry leaf (Helichrysum italicum) has no established association with liver injury and is commonly used in herbal formulations.

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 (Choi, Kim, Kim, Ban, Yang, & Park, 2021; Loquasto, Barrangou, Dudley, & Roberts, 2011; Kobayashi et al., 2013)
• Included in foods and supplements across the globe
• These probiotics are not known to be harmful to the liver or otherwise when used by healthy populations
• Typically associated only with mild GI symptoms, like gas or bloating

• Lecithin (from sunflower) is a phospholipid often used in foods and pharmaceuticals. It has a long-established safety profile.
• BioPerine®, a black pepper extract, is included in the formulation at 3 mg. It is commonly found in dietary supplements to support nutrient absorption.

We maintain rigorous safety oversight at every stage of product development and post-market activity:

• Our safety team monitors product safety continuously
• All manufacturing processes comply with current Good Manufacturing Practices (GMP) and FDA quality standards
• We maintain an open channel with regulatory authorities and are fully committed to transparency
• Provitalize is sold in compliance with regulations in more than 160 countries, including US, Canada, EU, and Australia
• Our ingredients and finished products undergo rigorous 3rd party testing and are verified by accredited laboratories (ISO17025)
• Provitalize has been in the global marketplace for 7 years and is consumed by approximately 500,000 consumers annually
• The incidence of one case of liver injury described in the article mentioned above amongst 500,000 consumers, is considered very rare and further supports the likelihood that the reaction is idiosyncratic - not related to inherent product safety issues

If a serious adverse event were ever received by our representatives, it would be immediately reported to the FDA or other authorities in compliance with current global regulatory obligations.

Provitalize has been used by millions of customers worldwide, many of whom share their feedback publicly. On Trustpilot, BBCo 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.

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
• There may be a large amount of variability in the strength, purity, or quality for the same ingredient assessed in different studies; for this reason, safety-related outcomes can also be vastly different  
• The strength of evidence can vary greatly as the population studied may be human, animal, or in vitro (cells, tissues, or microorganisms) - non-human or in vitro data has a much weaker application compared to human data

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
• They highlight individualized reactions or intolerances that are unique to the patient, but are not an indication that the product is unsafe for healthy populations 
• They involve patients that present with pre-existing medical conditions and/or other unique compromises that may result in atypical responses to an ingredient or product 
• They often involve a patient’s treatment from a single medical group, which may not include relevant medical history from other medical providers to help identify additional causes or risks for the reported event (separate from product use)

Context for Provitalize

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 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.

The case report offers a potential 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 related adverse reactions in our post-market surveillance
• Multiple factors (unrelated to our product) that have not been ruled out and that may have caused or contributed to the reported liver injury in the published case report
• Ingredient safety confirmed by globally recognized regulatory bodies, including FDA
• As of today, Provitalize remains a safe supplement when used as directed. We stand by the formulation’s integrity, scientific grounding, and regulatory compliance.

Most importantly, before taking any new dietary supplement it is recommended to consult with your health care provider if you have any medical conditions, take medications (including over-the-counter products), or other dietary supplements.

If you or someone you know experiences symptoms while taking any supplement:

1. Discontinue use immediately
2. Seek medical advice
3. Report the event to us or directly to the FDA’s MedWatch Program

We treat every concern with seriousness and are committed to ensuring the health and trust of our customers.

• Is Provitalize safe?
• Provitalize liver failure risk
• Turmeric liver toxicity facts
• Moringa supplement side effects
• Probiotics and liver health
• Menopause supplement safety
• BioPerine safety review
• Natural supplement adverse event

If you have further questions, reach out to our Customer Service Team at contact@thebbco.com.