Safety policy · Pre-launch draft
Product Safety, Complaints & Recalls
Identity, preparation, allergens, interactions, storage, lot codes, complaints, adverse events, and recall response.
1. Safety begins with the exact product
A botanical’s common name does not establish species, plant part, purity, preparation, dose, or suitability. Customers must follow the label for the exact SKU and lot and must not transfer directions from a tea, extract, essential oil, supplement, or online article to another preparation.
2. No individualized medical assessment
Lot & Leaf does not diagnose, prescribe, or determine whether a product is appropriate with a customer’s conditions, medicines, allergies, pregnancy, nursing status, surgery, or other products. A qualified clinician or pharmacist should be consulted where those factors may matter.
3. Elevated-risk situations
Unless the final label and a qualified professional support use, botanical products should be kept away from children and pets and should not be used during pregnancy or nursing, before surgery, with medication, or by a person with allergy, liver, kidney, cardiovascular, seizure, bleeding, respiratory, or other relevant conditions.
“Natural,” “traditional,” and “nicotine-free” are not safety guarantees. Concentrated oils and extracts can present materially different risks from dried plant material.
4. Allergens and cross-contact
The final label must disclose ingredients and legally required allergens. Before launch, the facility and suppliers must be reviewed for cross-contact with major food allergens and other botanicals. A precautionary statement must reflect a real assessment rather than substitute for controls.
5. Inspection, storage, and tamper evidence
Do not use a product with a broken seal, moisture, mold-like growth, insects, unexpected odor, foreign material, damaged packaging, unreadable lot code, or a condition inconsistent with its label. Store as directed, away from children, pets, moisture, excessive heat, and contamination.
6. Complaints and adverse events
The final support channel must collect the customer and product details reasonably necessary to investigate: contact information, order number, product, SKU, lot code, dates, use or exposure, symptoms or problem, concurrent products or medicines when voluntarily provided, and relevant photographs or records.
Serious or medically significant reports must be escalated promptly for regulatory assessment. Issuing a refund does not close a safety investigation or reporting duty.
7. Withdrawal and recall
Lot & Leaf may quarantine, stop sale, withdraw, or recall a lot when identity, labeling, contamination, supplier, testing, complaint, or regulatory information warrants action. Customers should follow recall instructions and should not consume, transfer, donate, or discard affected material unless instructed.
Order and batch traceability must support identifying recipients, sending notices, documenting responses, and evaluating recall effectiveness.
Primary-source trail
Official guidance used for this draft
These links explain the regulatory baseline behind this policy. They are not an endorsement of Lot & Leaf and do not replace product-specific professional advice.
- FDA — FDA 101: Dietary Supplements
Consumer safety, interactions, adverse effects, and limits of premarket approval.
- FDA — CGMPs for Food and Dietary Supplements
Food Part 117 and dietary supplement Part 111 manufacturing frameworks.