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Remedies & Cosmetics

This policy is a part of our Terms of Use. By opening and using a Herb-Oil.com store, you’re agreeing to this policy and our Terms of Use.

Protecting the Safety of our Members
Medicine, Medical Devices and Healthcare Products
Labeling Information

Protecting the Safety of our Members

Protecting the safety of our members is our absolute top priority. Our policy for the sale of medical drugs, devices and healthcare products aims to make sure that any listings in this category meet strict health and safety regulations. Because medicines, medical devices and healthcare products are regulated, it’s important to check that your items are allowed to be sold before listing them on Herb-Oil.

Stores must follow the below guidelines:

  • You can’t list any drugs, medications or medical devices that are available on prescription from a doctor, dentist, optometrist or veterinarian.
  • Find the status of a medication before listing by checking on the Food and Drug Administration (FDA) website.
  • If you’re selling over-the-counter items, you need to make sure they’re supplied in their original packaging and delivered to buyers before the item’s expiration date.
  • Descriptions of herbal and holistic remedies and other items can’t compare the products to prescription drugs, imply any non-FDA-approved treatments, or be marketed as having the same results as a prescription drug.
  • Medical devices that don’t require a prescription or supervision from a licensed practitioner can be listed, as well as some used devices, providing they are properly sanitized.
  • When listing a over-the-counter medicine, medical device or healthcare product, sellers may only refer to the specific details that are included in the Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations for that specific product.

Medicine, medical devices and healthcare products policy overview

We don’t allow sellers to list any drugs or medications that require a prescription from a licensed practitioner (such as a doctor, dentist, optometrist, or veterinarian). We also don’t allow the sale of prescription medical devices. Nor any substance the Food and Drug Administration (FDA) defines as requiring a prescription.

Most over-the-counter (OTC) items are allowed, as long as their listings don’t mention or compare them to prescription drugs, and the packaging is intact and the item hasn’t been tampered with.

Sellers may not claim any health benefits from legal substances for which the Food and Drug Administration (FDA) hasn’t approved them.

Restricted over-the-counter drugs (OTC):

Listings for ephedra-free products must state that the item doesn’t contain any ephedra. The listing needs to include photos that show that the item is ephedra-free.

Over-the-counter medications that contain non-prescription strengths of prescription drugs can be listed, but the concentration of the prescription drug needs to be mentioned in the listing.

The FDA maintains the Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations, where you can search for prescription drugs and over-the-counter products by either brand name or active ingredient.

The FDA Center for Veterinary Medicine maintains the Green Book where you can find information about drugs for animals.

Remember, you can’t list any prescription drug mentioned in the Orange Book or Green Book.

Before selling healthcare or hygiene-related products, be sure to review the relevant information on the FDA website .

Healthcare items subject to recall by the FDA or the Consumer Product Safety Commission (CPSC)

Medical devices

The packaging is intact and the item hasn’t been tampered with.

Otherwise:
A statement explaining that the item has been cleaned and handled in accordance with the manufacturer’s instructions. Sellers must clean and handle all medical devices in accordance with the manufacturer’s instructions before shipping. Sellers can’t list any medical device that has been altered in any way that significantly changes the product’s performance or safety specifications. All items must be delivered to buyers prior to a clearly marked expiration or “use by” date.
Sellers must clearly inform potential buyers, in the item description, if the device has been opened or used.
Sellers who have questions about legal obligations regarding sales of medical devices should consult with the FDA’s Center for Devices and Radiological Health by phone at 800-638-2041, or by email at dsmica@cdrh.fda.gov.

In addition, members should review the product manufacturer’s website before listing or buying any used medical device to obtain the latest information about any health or safety issues relating to that product.

Labeling Information

The ingredients in your products have to be listed on the jar, bottle and packaging. The ingredients on the label are listed in descending order of quantity, although there are a few exceptions to this rule with commercial products. Any ingredient that is classed as a drug comes first e.g. Retin A. Colors and fragrances are usually listed last. Any ingredient with a concentration below 1% can be listed anywhere as long as those with a higher concentration are shown before it.

The Directive states that your labels need to be written in inedible, easily legible and visibly characters.

You need to include on your label:

  • Batch Number
  • Contents by weight or volume
  • Instructions for storing
  • Instructions for using
  • Life of product – use by date after opening
  • Life of product – use by date unopened
  • List of ingredients
  • Product function – what it is for
  • Safety instructions
  • The date it was made
  • Your name, address and contact

Below are the FDA Guidelines to labeling and selling Remedies and Cosmetics. The FDA Guidelines are the RULE.

Labeling Information for Drug Products

For more information on labeling, including Physician Labeling Rule (PLR) requirements, guidances, presentations, sample templates and format tools, and established pharmacologic class (EPC) resources, please see the PLR Requirements for Prescribing Information web page

Labeling Resources

Find Prescribing Information

More Important Links:

Cosmetic Labeling Regulations

This section provides resources on regulatory requirements for cosmetic labeling. For a thorough explanation of cosmetic labeling regulations, see FDA’s Cosmetic Labeling Guide and the cosmetic labeling regulations themselves (21 CFR parts 701 and 740). Firms also may wish to discuss their labeling needs with a consultant.

On this page:

In this section:

More Resources:

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