Protect Consumers: Reclassify Zeolites From “Dietary Supplement” to “Drug” for Safe and Effective Use
What is zeolite?
Zeolite is a naturally occurring mineral or rock with a unique crystalline structure composed of aluminum, silicon, and oxygen. Known for its high cation-exchange capacity and ability to adsorb various substances, zeolites have been utilized in a variety of industrial and environmental applications, including water purification, air filtration, and as catalysts in chemical reactions.
Zeolites in the supplement industry
It is only since the early 2000s, that zeolite has been available as a dietary supplement. Prior to this it was never recognised as part of the human food supply. It has garnered online attention for its alleged detoxifying properties, allegefl capable of eliminating heavy metals and toxins from the body, without removing any essential nutrients. In contrast to supplements deeply rooted in ancient cultural practices, zeolites are newcomers to the market, lacking historical precedent in both animal and human health traditions.
*It is important to note that the following does not apply to not all companies selling zeolites*
The rise of zeolites as a "heavy metal detox" solution
Zeolites have been heavily marketed as a powerful "heavy metal detox" product, claiming to cleanse our bodies from toxins, of our modern, polluted, toxic world. The marketing narrative suggests that everybody on Earth is toxic due to exposure to this toxic world and all diseases can be traced back to heavy metal toxicity and that detoxifying with zeolites is the key to healing.
The marketing strategy employed is characterized by fear-mongering and predatory tactics, unscrupulously advocating for indefinite consumption of this heavy metal detox product across all age groups, including pregnant women and babies.
Testimonials and popularity
The marketing of zeolites has been bolstered by numerous positive testimonials from individuals who claim to have treated, healed, and even prevented various diseases by using zeolite supplements on a regular basis. These stories contribute to the growing popularity and perception of zeolites as a miracle cure. The most disturbing aspect of this marketing is the claim that zeolites are safe for pregnant and breastfeeding women, and even for babies. Never in the history of dietary supplements have pregnant and breastfeeding women, along with babies, been targeted as the primary audience for a "heavy metal detox."
Zeolite / Clinoptilolite does NOT have GRAS Status for dietary supplements
GRAS status, or "Generally Recognized as Safe," is a designation by the FDA indicating that a substance is considered safe by experts and does not require further FDA approval. To achieve GRAS status, there must be consensus among qualified experts based on scientific evidence or a long history of common use in food. Supplements need GRAS status to ensure their ingredients are safe for consumption, protecting consumers and providing confidence in the product's safety.
It's not just shocking but also dangerously reckless that zeolite or clinoptilolite, touted as safe for pregnant women and babies by sales reps, lacks GRAS status for human consumption as a dietary supplement or food. It does have GRAS status, but it has only been approved as an additive, specifically an anti-caking agent. Its safety hasn't been confirmed even for animals to consume beyond 1% of their diet by weight. For instance, 100g of feed allows for a maximum of just 1g of zeolite. This flagrant disregard for safety standards poses a grave risk to human health, particularly to vulnerable populations like pregnant women and infants.
The companies should have applied for NDI New Dietary Ingredient notification process, because clinoptilolite has no history of being used as supplements that would regard it as safe for human consumption. After the process it is up to the FDA to decide if the substance is safe to be used in dietary supplements. Until then, it should only be allowed to be used as it has been officially recognized as safe, as an anti caking agent. That is all.
It’s important to note that only the synthetic version (sodium aluminosilicate aka E554) has been granted GRAS status for use as an anti caking agent, and not the natural version (clinoptilolite). Clinoptilolite has no GRAS status in any classification.
Classification of supplements vs drugs
The fundamental difference between supplements and drugs, as per the FDA classification system, lies in their intended use and regulatory requirements:
Supplements: Dietary supplements are intended to add nutritional value to the diet, when we cannot get all of our nutrients from foods. They are regulated under the Dietary Supplement Health and Education Act (DSHEA) of 1994. Supplements do not require pre-market approval by the FDA, and their safety and efficacy do not need to be proven before marketing. However, they cannot claim to diagnose, treat, cure, or prevent any diseases. It is important to note that any product suggested or marketed for topical application cannot be categorized as a dietary supplement.
Drugs: Drugs are intended to diagnose, cure, mitigate, treat, or prevent diseases. They are subject to rigorous FDA regulations, including pre-market approval based on substantial evidence from clinical trials demonstrating safety and efficacy. Drugs must adhere to strict labeling, manufacturing, and marketing standards, and they require ongoing post-market surveillance to monitor adverse effects.
Zeolites do not contain bioavailable nutrients. Zeolites stands apart to other dietary supplements due to the fact it has never been in the food supply , prior to it being introduced to the dietary supplement market in 2005. There is a serious lack of scientific evidence supporting claims of detoxification and heavy metal removal, as well as its absence of a longstanding tradition of use in human consumption. Unlike other recognized supplements that serve specific roles in the body, zeolite does not offer distinct health benefits or support bodily functions. Its purported effects are primarily based on anecdotal evidence rather than substantiated scientific research..
Chelators and chelation therapy
A chelator is defined as a substance that can bind to metal ions, forming stable complexes and aiding in the removal of these metals from the body.
Zeolite is marketed as a “heavy metal removal” product, hence it is technically marketed as a chelator, although the companies may not use that particular word.
Chelators are typically classified as drugs rather than supplements. Chelation therapy involves the administration of FDA approved chelating agents, such as Calcium disodium versenate (EDTA), Dimercaptosuccinic acid (DMSA), Dimercaprol (BAL) Deferoxamine, Deferasirox and Deferiprone, to remove heavy metals or minerals from the body. Since this process involves medical intervention and has the potential to affect health outcomes, chelating agents are regulated as drugs by health authorities such as the FDA. This classification ensures that chelation therapy is administered under the supervision of qualified healthcare professionals and undergoes rigorous evaluation for safety and efficacy.
While many chelators available as dietary supplements are derived from natural sources and have documented health properties, such as Alpha-lipoic acid (ALA), Modified citrus pectin (MCP), Cilantro, Chlorella, N-acetylcysteine (NAC) and Silica (derived from horsetail herb or bamboo extract). Zeolite stands apart as an inorganic rock, devoid of any carbon-based life form (plant or animal) association. Unlike the supplement chelators mentioned, which offer specific proven health benefits and are even produced within the human body, zeolite lacks established scientific evidence supporting its purported health properties. Its classification as a dietary supplement raises concerns about safety and efficacy, particularly given its inorganic nature and reliance on anecdotal rather than empirical evidence. Moving zeolite from the 'dietary supplement' to the 'drug' classification would subject it to the rigorous testing and oversight processes of the FDA, ensuring that its safety and efficacy as a chelator, or heavy metal toxicity removal product, are thoroughly evaluated before public consumption. This shift is crucial to uphold consumer trust and safeguard public health.
It's concerning how companies omit the term 'chelator' from the labeling of zeolite products. Could this deliberate omission be an attempt to evade the rigorous testing requirements imposed on most other chelators in the market? I believe it's crucial to uphold fairness and equality in regulatory standards by subjecting zeolite to the same level of scrutiny and testing as other chelators. Enforcing consistent testing protocols will ensure consumer safety and prevent potential misrepresentation of the product's properties
There is no comprehensive peer reviews human study that has demonstrated the safety or effectiveness of zeolite for its marketed purposes over a long period of time. The reclassification of zeolite is necessary to perform the necessary studies to ensure it’s safety and efficacy, especially for pregnant women and newborns, as it is marketed.
Based on the provided information, the most appropriate classification for the nano-sized zeolite product in a spray bottle would be as a drug. This is due to the following reasons:
- Chemical Mode of Action: The primary mechanism involves ion exchange, a chemical reaction essential for the product’s function.
- Therapeutic Claims: The product is marketed with claims of treating diseases by removing heavy metals from the body.
- Internal and External Use: The product is intended for both internal detoxification and external treatment, such as for skin and eye conditions, indicating a therapeutic intent.
- Systemic Effect: The product claims to travel throughout the body, including crossing the blood-brain barrier, which implies systemic effects typical of drugs.
- Health Risk: Evidence suggests the product may also remove essential minerals from the body, posing significant health risks that necessitate thorough evaluation and regulation as a drug.
- Not a Dietary Supplement: Dietary supplements are intended to supplement the diet with bioavailable nutrients, and cannot make claims about diagnosing, treating, curing, or preventing diseases. Zeolite fails to be classified as an essential nutrient and its product’s marketing and intended uses go beyond the scope of dietary supplements and align more closely with drug regulations.
To comply with FDA regulations, the company should pursue the drug approval process, which includes providing substantial evidence of safety and efficacy through clinical trials. This would ensure that the product meets the rigorous standards required for products making such significant health claims.
If the FDA reclassifies zeolite supplements as drugs, it would bring several benefits to consumers:
- Enhanced Safety: Zeolite products would undergo rigorous testing for safety and efficacy before reaching the market. This ensures that only safe, well-studied products are available to consumers.
- Clearer Information: Drug classification requires detailed labeling, including information on dosage, contraindications, potential side effects, and interactions with other medications. This transparency helps consumers make informed decisions. This will mark a significant shift and a refreshing change from the censorship that many customers have previously experienced and currently experience.
- Quality Assurance: Zeolite products would be manufactured under stricter regulations, ensuring higher quality and consistency in the product formulation.
- Medical Supervision: Being classified as a drug would mean that zeolite use could be better supervised by healthcare professionals, ensuring that it is used appropriately and effectively for specific health conditions.
- Consumer Protection: The FDA would monitor and regulate marketing claims, preventing misleading advertisements and ensuring that only scientifically supported benefits are promoted.
Overall, reclassifying zeolite supplements as drugs would significantly improve consumer safety, product quality, and the accuracy of health information, leading to better health outcomes. - Access to Reimbursement: Once classified as drugs, zeolite treatments might be eligible for coverage under health insurance plans. This could make these treatments more affordable and accessible to a broader range of people who need them for specific medical conditions. This will be a vast improvement from the costly products currently on the market.
- Improved Research and Development: Drug classification often encourages more scientific research and clinical trials, as pharmaceutical companies invest in proving the efficacy and safety of their products. This increased research can lead to a deeper understanding of how zeolites work, potentially uncovering new therapeutic uses and improving existing treatments.
Thank you for taking the time to read about this important issue. If you or someone you know has been affected by zeolites, whether positively or negatively, please consider signing this petition. Your support can help ensure that zeolite products are safely and effectively regulated, protecting the health and well-being of all consumers.
Thank you for your support.
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