Vital Tides Research LLC. · Regulatory & Quality
Every material supplied by Vital Tides Research LLC. is sold exclusively for legitimate in-vitro, analytical and laboratory research conducted by qualified personnel. No product is intended for human or animal consumption, administration, injection, inhalation, ingestion, topical application, diagnostic use, therapeutic use or veterinary use. Our materials are not drugs, dietary supplements, cosmetics or medical devices, and none has been evaluated or approved by the U.S. Food and Drug Administration or any other regulatory authority for use in humans or animals. Nothing we publish is intended to diagnose, treat, cure, mitigate or prevent any disease or condition, or to affect the structure or function of the body. Not for human or veterinary use. Keep out of reach of children.
01Purpose and scope
This policy defines the only purpose for which Vital Tides Research LLC. (“Vital Tides”, “we”, “us”) supplies its materials, the obligations we accept as a supplier, and the obligations every purchaser accepts. It governs all products in our catalogue, every page of vitaltidesusa.com, product labels and inserts, certificates of analysis, order confirmations, email and telephone correspondence, and any social-media or third-party channel operated on our behalf.
The policy is written to reflect how federal law evaluates a product’s intended use: by the totality of objective evidence, not by a single disclaimer. For that reason it addresses what we sell, how it is configured, what we publish about it, to whom we sell it, and how we respond to signs of misuse.
02Regulatory basis
Under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 321(g)(1)), an article is a drug if it is intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease, or intended to affect the structure or any function of the body. Under 21 CFR 201.128, intended use is determined by the objective intent of the persons legally responsible for the article, which may be shown by labeling claims, advertising, oral or written statements, and the circumstances surrounding its distribution. A new drug may not be introduced into interstate commerce without an approved application (FD&C Act § 505(a); 21 U.S.C. § 355(a)).
Vital Tides does not intend, market, configure or distribute any product for any use that would make it a drug, and does not permit such use by purchasers. Specifically:
- We are a supplier of research chemicals. We are not a pharmacy, a compounding facility under FD&C Act § 503A, or an outsourcing facility under § 503B, and we do not dispense, prescribe or compound drugs.
- Our materials are not manufactured, tested or released as finished pharmaceuticals under 21 CFR Parts 210 and 211, and they are not a substitute for any approved drug product.
- Certain compounds in our catalogue are identical or related to the active ingredients of FDA-approved drug products. The material we supply is not that drug product, carries none of its approval, and must never be used in its place.
- Our materials are not investigational new drugs. Any clinical investigation in humans requires an investigational new drug application under 21 CFR Part 312 (or a documented exemption) and institutional review board oversight under 21 CFR Parts 50 and 56. Vital Tides does not supply material for clinical investigations.
03Permitted research use
Our materials may be used only for in-vitro and analytical laboratory work performed by personnel trained in chemical handling, in a facility equipped for that work. Examples of permitted use include:
- analytical method development and validation, including HPLC, LC-MS and spectroscopic methods;
- use as a reference or comparator material in identity, purity, stability or degradation studies;
- biochemical and biophysical assays, such as receptor-binding, enzyme-inhibition and structural studies;
- cell-culture and other in-vitro experimental systems; and
- formulation-stability and physicochemical characterisation studies that do not involve administration to any living organism.
04Prohibited uses
The following are prohibited without exception, whether by the purchaser or by anyone to whom the purchaser provides the material:
- administration to any human by any route, including injection, ingestion, inhalation, intranasal, sublingual, transdermal or topical application;
- administration to any animal, including companion animals and livestock, or any veterinary use;
- use in foods, beverages, dietary supplements, cosmetics or any consumer product;
- diagnostic, therapeutic, clinical or wellness use of any kind, including in any medical, aesthetic, anti-aging, fitness or weight-management practice;
- resale, repackaging, relabelling or redistribution for any of the uses above, or presenting our material as a drug, supplement or pharmaceutical product; and
- any use that violates federal, state, local or international law.
05Purchaser qualification and attestation
Purchasers must be at least 18 years of age, or the age of majority in their jurisdiction if higher. Before any order is accepted, the purchaser must affirmatively attest at checkout that the materials are purchased solely for lawful laboratory research, that they will not be administered to any human or animal, and that the purchaser accepts this policy and our Terms and Conditions.
By placing an order, the purchaser further represents that they, or the institution they act for, are familiar with the safe handling of research chemicals and hold any licence, registration or institutional approval their work requires. We may request information about the purchaser’s institution, laboratory or intended research application at any time, before or after shipment, and may decline or cancel an order if that information is not provided or is not consistent with research use.
06Order screening and refusal of sale
We review orders and correspondence for indications of non-research use. We will refuse or cancel an order, refund it in full, and may close the associated account where, in our judgment, there is reason to believe a product is intended for human or animal use. Indicators include, without limitation:
- any statement or question about personal use, dosing, injection, administration, effects, side effects or results in a person or animal;
- requests for administration supplies, or for guidance on preparing material for administration;
- references to treating, preventing or managing any condition, or to body-composition, performance or appearance goals; and
- order patterns or resale indicators that are inconsistent with laboratory research.
07Scientific information we publish
Product pages may include chemical identity data (sequence, molecular formula, molecular weight, CAS number where assigned), physical form, storage conditions, analytical results, and neutral summaries of the published scientific literature, so that researchers can identify a compound accurately and design their work. This information:
- describes what has been reported in the literature; it is not a claim, promise or suggestion that any product is safe or effective for any purpose in humans or animals;
- does not include, and must never be read as, dosing, administration, treatment, “protocol” or personal-use guidance; and
- is reviewed against this policy before publication and periodically thereafter.
Findings from cell-culture and animal models frequently fail to translate to humans, and clinical investigation is not regulatory approval. Researchers should consult and cite primary sources directly.
08Product configuration and accessories
We do not sell syringes, needles, injection pens, autoinjectors or other administration devices, and we do not offer diluents or solvents for the purpose of preparing material for administration. We do not assemble kits that pair a research compound with the means of administering it, and we do not describe our products by reference to a route of administration in a person or animal.
09Identity, purity and analytical verification
Research is only as reliable as its reagents. Each lot we release is supported by a certificate of analysis (COA) from an independent analytical laboratory. Our certificates are published on the Lab Tests page and open as the laboratory’s original report, with laboratory-side verification where the laboratory offers it.
| Purity | Reverse-phase high-performance liquid chromatography (HPLC), reported as percentage peak area. |
|---|---|
| Identity | Confirmation of molecular mass or structure by liquid chromatography–mass spectrometry (LC-MS) or FTIR, as reported on each certificate. |
| Content | Measured content per vial, reported against the labelled amount where the laboratory provides it. |
| Traceability | Each certificate is tied to a specific lot and test date. Researchers should match the lot on their vial to the corresponding certificate. |
A certificate reflects the sample submitted for analysis at the time of testing. Purchasers who require additional characterisation for their work, such as endotoxin, residual solvents, counter-ion or water content, should perform or commission it independently.
10Labeling
Primary containers and outer packaging carry the statement “For Research Use Only” and identify the compound and labelled quantity. Product pages, the cart, checkout and order confirmations repeat the research-use-only restriction. No label, insert or page bears directions for use in humans or animals.
11Handling, storage and laboratory safety
The toxicological properties of many research compounds have not been fully characterised. Materials should be handled only by trained personnel under the purchaser’s chemical hygiene plan, using appropriate personal protective equipment and engineering controls, and in accordance with OSHA’s Occupational Exposure to Hazardous Chemicals in Laboratories standard (29 CFR 1910.1450) or its equivalent. Store materials as stated on the product page, keep them secured from unauthorised access, and dispose of them as chemical waste under applicable regulations.
12Marketing and communications standards
Every channel we operate is held to the same standard as our labels. We do not publish or permit, on our site, in email, on social media or through affiliates:
- testimonials, reviews describing personal use, “before and after” content, or reported results in people or animals;
- claims, express or implied, that a product treats, prevents or mitigates disease, or alters weight, appetite, metabolism, hormones, muscle, healing, sleep, cognition, mood, sexual function, skin, hair or any other structure or function of the body;
- dosing calculators, cycles, stacks, protocols or administration guides; or
- endorsements by persons presented as using our products.
Content found to fall short of this standard is removed or corrected promptly.
13Purchaser responsibilities
The purchaser is solely responsible for determining that its intended research is lawful, for obtaining any approvals that research requires, for compliance with all laws governing the purchase, import, possession, handling, use and disposal of the materials, and for the conduct of everyone to whom it gives access to them. Purchasers outside the United States are responsible for the import laws of their jurisdiction. A purchaser who breaches this policy assumes all risk arising from that breach and agrees to indemnify Vital Tides as set out in our Terms and Conditions.
14Records and documentation
We maintain records of purchaser attestations, order screening decisions, cancelled orders, lot numbers and certificates of analysis, and the review history of published product content. These records support the research-only character of our distribution and are available to regulators on lawful request.
15Reporting suspected misuse
If you believe a Vital Tides product is being sold, promoted or used for human or animal use, or if you find content on our site or channels that is inconsistent with this policy, please contact us at [email protected] or (858) 461-8002. We review every report and act on it.
16Relationship to our Terms; review of this policy
This policy forms part of, and is incorporated into, our Terms and Conditions. Where the two differ, the provision more protective of research-only use applies. We review this policy at least annually and whenever relevant law, regulatory guidance or enforcement practice changes; the effective date above reflects the current version.
This policy describes Vital Tides’ commercial terms and practices. It is not legal or medical advice, and it is not a representation that any product is safe or suitable for any purpose other than in-vitro and analytical laboratory research.
