DalPay Retail's Dietary & Herbal Supplement Best Practices
The purpose of this best practices document is to provide basic guidance and information to help a supplier ensure that its products and website are in compliance with U.S. Food and Drug Administration (FDA) and other governmental regulations regarding herbal supplements and remedies, dietary supplements, natural product supplements, nutraceuticals, and nutritional supplements.
Also covered are pharmaceuticals not prohibited by our policies, ingestible products or materials, or any other product designed or marketed to promote health or well-being as determined by us at our sole discretion (collectively referred to in this document as "Supplements and Similar Materials").
The information provided in this document is for guidance and informational purposes only and is not intended as legal advice.
Your Website Must Contain
- This statement at the bottom of every page: "Information, statements and products on this website have not been evaluated by the FDA and are not intended to diagnose, mitigate, treat, cure, or prevent any disease or health condition." (However, untrue or misleading information in one part of your site will not be mitigated by inclusion of such a "disclaimer.")
- A "Cart Checkout Acknowledgement" which each purchaser must affirmatively agree to in connection with each purchase of a Supplement or Similar Material. This acknowledgement should be placed in the shopping cart. (See 'Cart Checkout Acknowledgement' section below.)
- Product descriptions and benefits must be absolutely clear and unambiguous to consumers as to the intended use of the products and must not be left open for interpretation.
Any directions for the intended use of your product must be clear, truthful, unambiguous and concise.
Your Website Must NOT Contain
- Products which are regulated by the FDA or any other governmental entity, which have been or may be, or which contain ingredients that have been or may be, classified as a "drug" under the laws, rules and regulations of the U.S. or any foreign governmental agency with jurisdiction over the products.
- Claims that your product will diagnose, mitigate, treat, cure or prevent any disease or health condition.
- Claims of health benefits that you cannot prove.
- Misleading language as to the product description, product benefits or level of success resulting from the use of the products.
- Customer testimonials that contain claims of having diseases or health conditions that were treated, diagnosed, prevented or cured by using your products.
- Claims that your products act as a substitute for a reasonable standard of medical care.
You also must
- Fully comply with any laws, rules and regulations (whether federal, state, local or foreign) which relate to the manufacture and offering for sale of any Supplements and Similar Materials you offer to us or resale through our commerce solution (including without limitation any of the rules and requirements of the FDA).
- Provide us with any documentation, certification, and/or assistance we may require in verifying your compliance with this best practices document and your compliance with the terms of your agreement with us.
- Follow Current Good Manufacturing Practices as published by the FDA and show proof of marketing authorization for medicinal products from a European Union member state's competent authority (for example with the UK's Medicines and Healthcare products Regulatory Agency as Reference Member State), if you wish to sell to customers within the EU.
- Accept full responsiblity for investigating and determining the causes of any violations of this best practices document or applicable laws, rules and/or regulations that may exist on your website.
- Fully review your websites, products, labels and other labeling and promotional materials to ensure that the claims it makes does not cause any violations of FDA regulations or those of any foreign governmental agency with jurisdiction over the products.
Cart Checkout Acknowledgement
The following statement and checkbox should be placed in the shopping cart (either yours or in the DalPay Checkout final checkout step).
[ ] I understand and acknowledge the following: (a) actual product packaging and materials may contain more and/or different information than that shown on the website through which the product(s) are purchased; (b) I will read and follow all labels, warnings and directions in connection with using or consuming the product(s), and will contact a health care provider immediately if I suspect I have a medical problem or reaction; (c) the content on this website is for reference purposes and is not intended to substitute for advice given by a physician, pharmacist, or other licensed health-care professional; (d) the product(s) purchased are not intended to diagnose, mitigate, treat, cure or prevent any disease or health condition, and I will not use any information or statements contained on the website through which this product is purchased, or contained on or in such product(s), for such purposes.
NOTE: The check-out process CANNOT continue until this box is checked by the customer.
Information in this document is not intended to be an all-inclusive list, it is only guidance to issues that may occur.
Consequences of Violations
Non-compliance with FDA or EU regulations by any seller listing Supplements and Similar Materials on the DalPay Retail platform may result in actions including, but not limited to:
- Suspension of account, while violations are cleaned up.
- Restriction of sales (only those products on your site which are not Supplements or Similar Materials will be allowed to be sold.)
- Termination of your account, if you cannot become FDA or otherwise compliant for the market into which sales are to be made.
- Order cancellations and refunds, freezing of funds/possible forfeiture of funds due to the need to cover card association fines.
Useful information and links to resources
- U.S. Food and Drug Administration
- Federal Food Drug and Cosmetic Act
- FDA and Dietary Supplements
- Warning Letters
- Federal Trade Commission (FTC), Dietary Supplements - An Advertising Guide for Industry
- Dietary Supplement Health and Education Act of 1994 (DSHEA)
- UK Medicines and Healthcare products Regulatory Agency (MHRA)
- US National Center for Complementary and Alternative Medicine
If you have any questions regarding this Best Practices document, please contact us.