CLE Holistic Health is a Canadian natural health products company, established in 2010. Alistrol and Naavudi are manufactured in Canada; CLE Mineral Drops is manufactured in the United States. Each product is therefore governed by the regulatory framework of its country of manufacture and of each market in which it is sold.

Canada: Site Licences and Good Manufacturing Practices

Under the Natural Health Products Regulations (SOR/2003-196), every establishment that manufactures, packages, labels or imports natural health products for sale in Canada must hold a Health Canada Site Licence for those specific activities. Licensed sites must operate under Health Canada's Good Manufacturing Practices (GMP), which require:

• Qualified personnel and an independent quality-assurance function
• Suitable premises with appropriate environmental controls
• Equipment qualification, calibration, maintenance and sanitation programs
• Raw-material identity, specifications and documented release
• Master manufacturing instructions and controlled batch records
• In-process controls and finished-product specifications
• Laboratory testing and formal quality-assurance release
• Stability, complaint handling, recall procedures and record retention

Two authorizations are distinct and should not be confused. A Site Licence authorizes an establishment and its licensed activities. A Natural Product Number (NPN) authorizes a specific product, its approved medicinal and non-medicinal ingredients, specifications, recommended conditions of use and label. Alistrol is registered by Health Canada under NPN 80047013.

United States: 21 CFR Part 111

Dietary supplements marketed in the United States are subject to FDA's Current Good Manufacturing Practice regulations for dietary supplements (21 CFR Part 111). These address personnel, physical plant, equipment, production and process controls, component and finished-product specifications, laboratory operations, packaging, labelling, holding, distribution, returned products and records. Facilities that manufacture, process, pack or hold food for U.S. consumption must also register with FDA where required.

What this means for practitioners

Through the CLE Practitioner Program, practitioners can request the regulatory and quality documents relevant to the products they recommend, including product licence (NPN) details, manufacturing-site licensing information, product specifications and Certificates of Analysis (see Question 13). Our aim is complete transparency about the controls behind every bottle.

Farm-to-capsule means that quality is managed across the entire botanical supply chain, not only verified at the end. CLE grows the botanicals used in its formulas on farms it owns, which gives us direct control over the variables that most influence phytochemical consistency.

The chemical composition of a medicinal plant is not fixed. It varies with species and chemotype, cultivation conditions, plant part, maturity at harvest, post-harvest handling, drying and extraction. A rigorous botanical program controls each of these variables deliberately.

Botanical authentication

Plant identity is established using appropriate taxonomic, organoleptic and analytical methods. Depending on the material, these include macroscopic and microscopic examination, high-performance thin-layer chromatography (HPTLC) fingerprinting and high-performance liquid chromatography (HPLC). Authentication matters most where related species differ in phytochemical profile or safety, a recognised source of adulteration in the botanical trade.

Agricultural control

Growing region, soil composition, water quality, agricultural inputs and environmental exposures all shape the resulting plant material. Owning the farms allows CLE to manage cultivation practices, input use, contamination risk and harvest handling directly rather than relying on supplier declarations alone.

Plant-part selection

Constituent profiles differ markedly between leaves, flowers, berries, seeds and roots of the same species. Each formula specifies the plant part consistent with its formulation rationale and the relevant literature, for example hawthorn berry and daikon seed in Alistrol.

Lot traceability

A documented chain of custody links each field and harvest to its processing records, ingredient lots and finished-product batches. Full traceability allows any finished batch to be traced back to its source, and any source issue to be traced forward to the batches it affected.

Post-harvest processing is among the most decisive steps in botanical quality. Freshly harvested plant tissue contains water, active enzymes and reactive constituents that begin to change the moment the plant is cut.

Harvesting

The optimal harvest window depends on the species, the plant part and the target phytochemical profile. Timing influences the concentration of flavonoids, oligomeric proanthocyanidins, organosulfur compounds and other constituents. Material is inspected and moved into processing promptly to limit enzymatic degradation and microbial growth.

Drying

Controlled drying lowers water activity, which limits microbial proliferation and slows hydrolytic and oxidative degradation. Critical parameters include temperature, relative humidity, airflow, duration and the final moisture specification.

• Too much heat can degrade thermolabile constituents and volatile compounds.
• Too little drying increases microbiological and stability risk.

There is no universal "best" drying method. Low-temperature processing is not inherently superior for every botanical; the correct conditions are established material by material.

Extraction

Where standardized extracts are used, production may involve controlled solvent extraction, filtration, concentration and drying. The resulting extract is shaped by solvent polarity and composition, temperature, contact time, solvent-to-material ratio and the characteristics of the starting material.

Standardization

Selected phytochemical markers are measured with validated analytical methods to confirm batch-to-batch consistency against a defined specification. The meaningful question for practitioners is not whether an ingredient is "concentrated", but whether its identity, composition and stability are properly characterized and documented.

Raw-material quarantine is a central safeguard of GMP. Incoming materials cannot enter production until they have been tested and formally released by the quality unit.

1. Receipt. Containers are inspected for damage, tampering, contamination and correct labelling, and reconciled against purchasing records. Each material is assigned a unique lot identity.
2. Quarantine. Materials are placed in a controlled status that prevents use, by physical segregation or a validated inventory-control system.
3. Sampling. Representative samples are drawn under written procedures designed to avoid cross-contamination and sampling bias.
4. Specification testing. Depending on the risk profile: botanical identity, marker compounds, microbiological quality, elemental impurities (heavy metals), pesticide residues, residual solvents and other relevant parameters.
5. Quality-assurance disposition. Authorized quality personnel review the documentation and analytical results, then approve, reject or hold the material for investigation.
6. Controlled release. Only approved material is made available to manufacturing.

A mature quality system also governs out-of-specification (OOS) investigations, deviations, corrective and preventive actions (CAPA), supplier qualification and change control.

Analytical testing establishes whether ingredients and finished products meet their defined specifications. A credible quality program uses a risk-based combination of raw-material testing, in-process controls and finished-product testing.

Reading a Certificate of Analysis (COA)

A useful COA identifies the material or product tested, its lot number, each parameter tested, the specification, the result, the method and the laboratory responsible. When reviewing any COA, check that:

• The lot number matches the product in hand
• Results are reported against a stated specification, not as a bare "pass"
• The testing laboratory is identified
• It is clear whether the COA covers a raw material or the finished product

A raw-material COA and a finished-product COA provide different assurances and are not interchangeable. CLE makes relevant lot-specific quality documentation available to enrolled practitioners on request.

Encapsulation converts a botanical formulation into an accurate, convenient dosage form. A well-controlled process manages ingredient compatibility, blend homogeneity, fill accuracy, environmental exposure and packaging integrity.

1. Formulation development. Each formula begins with defined ingredient specifications, target quantities, excipient selection and master manufacturing instructions. Ingredient interactions, powder behaviour and stability shape the process.
2. Precision dispensing. Released ingredients are weighed on calibrated equipment against the controlled batch record, with independent verification.
3. Blending. Particle size, bulk density, flowability and the proportion of each ingredient affect segregation risk. Blend time and method are set to achieve a uniform mix, so that each capsule delivers the labelled amount.
4. Encapsulation. Equipment is set to the specified capsule size and fill weight. In-process checks monitor fill weight, closure, appearance and machine performance throughout the run.
5. Environmental control. Moisture, temperature, oxygen and light can degrade sensitive botanical constituents. Controls are matched to the chemistry of each formulation.
6. Packaging. Container materials, closures, induction seals and desiccants are selected to protect the product throughout its shelf life.
7. Batch release. Batch records, deviations, in-process results and finished-product testing are reviewed by quality assurance before release.

What fulvic substances are

Fulvic substances are the lowest-molecular-weight, most oxidized fraction of humic substances. They are complex mixtures of organic molecules formed over geological time by the microbial and chemical transformation of plant matter. Unlike humic acids, fulvic acids remain soluble across the full pH range.

Their chemistry is defined by a high density of oxygen-containing functional groups, principally carboxyl (–COOH) and phenolic hydroxyl (–OH) groups. These groups give fulvic molecules a high cation-exchange capacity and allow them to form soluble complexes with multivalent mineral cations such as calcium, magnesium, iron and zinc, as well as trace elements.

The CLE source

The fulvic mineral extract in CLE formulations is derived from an exclusively owned prehistoric shale deposit. Controlling the source gives CLE continuity of supply and a consistent geological origin, two factors that matter because the composition of humic and fulvic materials varies considerably between deposits.

Proposed role in CLE formulations

Each CLE formula is infused with the Fulvic Mineral System to supply a broad spectrum of naturally occurring trace minerals in an organically complexed form. In the scientific literature, fulvic substances have been studied for:

• Mineral complexation: keeping minerals in soluble, complexed forms across varying pH.
• Antioxidant capacity: phenolic and quinone structures with radical-scavenging activity in laboratory models.
• Membrane interactions: amphiphilic character that may influence how some molecules interact with biological membranes, studied mainly in experimental systems.

Interactions with botanical constituents

Because fulvic molecules are chemically active, formulation must account for how they behave alongside botanical compounds:

• Polyphenols and flavonoids (such as hawthorn proanthocyanidins) can engage in hydrogen bonding and metal-bridged associations with fulvic structures, which may influence solubility.
• Metal-sensitive constituents may be affected by the trace minerals fulvic substances carry, which is why compatibility and stability are evaluated for each formulation.
• Organosulfur compounds (for example from garlic) are reactive and benefit from moisture and oxygen control, regardless of the fulvic matrix.

Quality controls specific to fulvic materials

Humic and fulvic materials originate from geological deposits, and geology can carry elemental contaminants. Elemental-impurity analysis by ICP-MS (lead, arsenic, cadmium, mercury) is therefore an essential control for any fulvic ingredient, alongside microbiological testing and consistency of the extraction process.

CLE formulas are built on three principles: traditional and scientific precedent for each botanical, complementary mechanisms across ingredients, and a consistent mineral foundation through the Fulvic Mineral System.

Example: Alistrol

Alistrol combines hawthorn berry, garlic, holly leaf and daikon seed extracts with the Fulvic Mineral System, and is registered by Health Canada (NPN 80047013) to help maintain cardiovascular health.

• Hawthorn (Crataegus spp.): a long-studied cardiovascular botanical. Its flavonoids (including vitexin and hyperoside) and oligomeric proanthocyanidins are the constituents of principal research interest.
• Garlic (Allium sativum): its organosulfur compounds, including allicin-derived compounds and S-allyl cysteine, are widely studied for cardiovascular support.
• Daikon seed (Raphanus sativus): a seed traditionally used in East Asian practice, containing glucosinolates and their isothiocyanate derivatives.
• Holly leaf: a leaf with a long history in traditional preparations, contributing polyphenolic and triterpenoid constituents.

How we describe evidence

We distinguish between levels of evidence: human clinical trials, mechanistic and preclinical studies, and traditional use. Practitioners can request product monographs and supporting references for each formula through the Practitioner Program.

Botanical products are pharmacologically active, and patient-specific review is essential, particularly for patients on prescription medication. The considerations below reflect commonly cited monograph cautions for key ingredients; they are not exhaustive.

CLE products are marketed within two distinct frameworks, and our language is written to respect both:

• Canada: claims for a licensed natural health product must match the recommended use authorized under its NPN.
• United States: under the Dietary Supplement Health and Education Act (DSHEA, 1994), dietary supplements may carry structure/function statements accompanied by the required FDA disclaimer, but may not claim to diagnose, treat, cure or prevent disease.

For this reason, CLE describes its products in terms such as "helps maintain healthy blood pressure already within the normal range" or "supports cardiovascular health", never as treatments for hypertension or any other disease. We ask practitioners to use the same framing in patient-facing materials, and our marketing resources are written to that standard.

Shelf life is assigned on the basis of stability data showing that the product continues to meet its specifications through the expiry date under labelled storage conditions.

Recommended storage for clinic inventory

• Store at controlled room temperature (15–25 °C), away from heat sources and direct sunlight.
• Keep containers tightly closed with the desiccant in place; avoid humid areas such as bathrooms.
• Rotate stock first-expiry, first-out (FEFO) and record lot numbers dispensed to each patient.
• Do not repackage capsules into unlabelled containers; doing so breaks lot traceability and the stability conditions.

Lot numbers and expiry dates are printed on every bottle and should be recorded for any patient query or adverse-event report.

Post-market vigilance is a shared responsibility between manufacturer and practitioner.

1. Report to CLE. Contact us with the product name, lot number, a description of the event, its timing and any concomitant medications. Email info@cleholistichealth.com or call 604-715-4286 (9 AM to 6 PM Pacific).
2. Investigation. Each complaint is logged, assessed, linked to batch records and retained samples where applicable, and closed with a documented outcome and corrective action if required.
3. Regulatory reporting. Practitioners may also report directly: in Canada through Health Canada's Canada Vigilance Program (MedEffect Canada), and in the United States through FDA's MedWatch / Safety Reporting Portal.

Enrolled practitioners can request the following, subject to availability and approval for disclosure:

• Product licence details (NPN) and authorized label text
• Manufacturing-site licensing information
• Finished-product specifications and lot-specific Certificates of Analysis
• Ingredient specifications, including plant part and extract details
• Product monographs and supporting scientific references
• Allergen and excipient statements
• Storage and stability information

The CLE Practitioner Program supports naturopathic doctors, physicians, pharmacists and integrative clinics in recommending and supplying CLE products. Enrolled clinics can choose between:

• Wholesale supply for in-clinic dispensing, with practitioner pricing provided after enrolment. Orders are placed by the case and formulas can be mixed.
• Patient referral, with a personal referral link and code for patients who prefer to order directly.

Enrolled practitioners also receive access to the quality documentation above, product monographs and compliant patient-education materials. Apply on the CLE Practitioner Program page.