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Is FODZYME safe? How do you test for quality and safety? Has it been approved by the FDA?Updated 6 days ago

We are committed to providing a product that not only meets but exceeds industry standards for quality and safety. 


By law, the United States Food and Drug Administration (FDA) regulates health supplement products but does not pre-approve them. This is why we have on our website and product labels the disclaimer: “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”


Here’s how we run third-party tests for every single batch:


Enzyme Activity and Stability

Our enzymes are rigorously tested to ensure consistent activity profiles. We carry out standard, internationally accepted enzyme-specific assays recommended by the Food Chemicals Codex (FCC) that not only test for enzyme performance after formulation of every batch but also monitor it over prolonged storage periods under different temperatures and humidity conditions. This helps us ensure that there are no changes in activity that may indicate degradation or loss of function of individual enzymes over the shelf life of FODZYME. 


Allergens

Ingestion of microbial enzymes, like the ones in FODZYME, is not likely to be of concern with regard to food allergy. No major allergen substances are used in the fermentation, recovery processes, or formulation of our product. Nevertheless, we rigorously evaluate every batch of FODZYME for all major allergens, such as peanut, gluten, soy, and almond, to ensure that it will not be responsible for an allergenic response upon ingestion. Additionally, as they are obtained from fungal sources, our enzymes are checked thoroughly to ensure that there is no presence of any mycotoxins such as aflatoxin. 


Contaminants

Contaminants or impurities can interfere with enzyme activity as well as pose a health risk to the consumer. To avoid this, we test for two key contaminant groups per the regulatory recommendations for food-grade enzymes: microbiological and heavy metals. We carry out stringent tests for pathogens of concern, such as *Salmonella* spp., *Escherichia coli*, *Staphylococcus aureus,* and *Pseudomonas aeruginosa*. We also strictly test for the absence of other bacterial, yeast, and mold contaminants, taking care to mitigate the microbial risks to our customers. Even though our production microbial strains for all three enzymes meet the criteria for non­-toxigenicity and non-pathogenicity, we take extra precautions to ensure that no production organisms are present in the final product. We carefully choose our enzymes to be derived from microbial fermentation processes which carry a negligible heavy metal contamination risk. We take all the necessary steps to screen our raw materials for heavy metal content, implement Good Manufacturing Practices (GMP) to minimize contamination risks during production, and conduct regular testing of FODZYME for heavy metal levels such as lead, cadmium, arsenic, and mercury. 


Safety

All three enzymes in FODZYME are fungal carbohydrases and are explicitly labeled as Generally Recognized As Safe (GRAS) by the FDA. Our production strains are well-characterized microbes that have been tested for the safe production of food-grade enzymes for decades. Coupled with the long history of safe use, Kiwi’s own GRAS determination carries sufficient toxicological testing data confirming no evidence of toxicological concern regarding the safety and consumption of FODZYME.


Reference

  1. Orally Administered Enzyme Food Supplement Safety Overview Enzyme Technical Association.; 2012. Accessed May 8, 2024. https://www.enzymetechnicalassociation.org/wp-content/uploads/2018/10/Orally-Administered-Enzyme-Food-Supplement-Safety-Overview11.pdf
  2. Food Chemicals Codex (FCC) | FCC | Online. Foodchemicalscodex.org. Published 2023. Accessed May 8, 2024. https://www.foodchemicalscodex.org/
  3. Pariza MW, Foster EM. Determining the Safety of Enzymes Used in Food Processing. Journal of food protection. 1983;46(5):453-468. doi:https://doi.org/10.4315/0362-028x-46.5.453
  4. Pariza MW, Johnson EA. Evaluating the Safety of Microbial Enzyme Preparations Used in Food Processing: Update for a New Century. Regulatory toxicology and pharmacology. 2001;33(2):173-186. doi:https://doi.org/10.1006/rtph.2001.1466
  5. Carsten Bindslev-Jensen, Per Stahl Skov, Roggen EL, Hvass P, Ditte Sidelmann Brinch. Investigation on possible allergenicity of 19 different commercial enzymes used in the food industry. Food and chemical toxicology. 2006;44(11):1909-1915. doi:https://doi.org/10.1016/j.fct.2006.06.012
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