Age Verification Requirements for Controlled Substances
For any business requesting to promote products related to weight loss or sleep enhancement (including products intended to improve, induce, or support sleep), a robust age gate is required.
To be considered compliant, the age gate must:
Use a Specific Format: The user must be required to input their full date of birth in a MM/DD/YYYY format.
Avoid Simple "Yes/No" Prompts: Passive "I am over 21" checkboxes or simple "Enter" buttons are insufficient and will lead to immediate submission denial.
Placement: The age gate must be active either upon entry to the website or integrated directly into the SMS opt-in workflow before or during any personal data is collected.
Regulatory Intent and Scope
This regulation is aimed specifically at protecting individuals under the age of 21+
Broad Application to All Ingredients - It is critical to understand that these restrictions are not limited to pharmaceutical or lab-synthesized products. This requirement applies equally to:
Clinical/Prescription Products: Medications or synthetic supplements.
Natural/Herbal Ingredients: Any "natural" remedies, botanical extracts, or holistic supplements marketed for weight management or sleep aid.
Failure to implement a MM/DD/YYYY age gate for these categories, regardless of the "natural" status of the ingredients, will result in the rejection of the Toll-Free verification request.
Prohibition on Marketing and Promotion of GLP-1
Marketing or promotion of GLP-1 (Glucagon-like peptide-1) receptor agonists and similar weight-loss or metabolic medications is not allowed. While previous guidelines may have allowed for "indirect" marketing, where the focus was on the storefront or brand rather than the specific product, current carrier standards and internal compliance protocols now mandate a restriction on any promotional content for these substances.
Permissible Informational Use Cases
Submissions from businesses handling these products will only be considered for approval if the messaging intent is purely informational or transactional. Marketing-related traffic for these entities will result in a denial. Approved use cases include:
Two-Factor Authentication (2FA): Secure account login and verification.
Transactional Notifications: Order confirmations and receipts.
Logistics Updates: Real-time delivery and shipping tracking.
Account Management: Appointment reminders or essential account status alerts.
Regulatory Compliance and FDA Approval
The verification process involves a rigorous review of the product’s legal and regulatory standing.
FDA Status: If the substance being referenced has not received formal approval from the Food and Drug Administration (FDA), the likelihood of submission approval is reduced.
State-Level Legality: During manual review, the verification team evaluates the legality of the substance across all 50 U.S. states. If the product is restricted, banned, or operates in a legal "gray area" in any single state, the submission will be rejected to maintain nationwide carrier compliance.
Special Considerations: Research and Laboratory Use
Requests for messaging related to the sale of these substances for testing purposes, clinical investigations, or laboratory research (e.g., within university settings or pharmaceutical R&D) will be evaluated on a case-by-case basis.
Note: While these specialized use cases undergo a distinct review process, submission does not guarantee approval.
Need more help?
If you have any more questions or concerns regarding compliance and Textline, feel free to message us at +1 (415) 849-4349 or email us at [email protected].