Here is and example of one of the messages that we just received from Amazon:

Hello,

This is to inform you that the following detail pages are at the risk of removal from our catalog. You must take remedial actions before 4/8/2023, UTC, else your listing(s) will be removed from our catalog. It is your obligation to ensure that the products you offer, comply with all applicable laws, regulations, and Amazon's policies.

ASIN: B0BHV3SK1J, SKU: NailBalm-NailSaltsBUNDLE, Title: Nail Fungus Treatment Bundle - Extra Strength, Herbal, Anti-fungal Treatment for Finger Nails & Toenails – Disinfects & Repairs Thick, Cracked, Flakey Nails – Safe for The Whole Family

Why is this happening?

This product has been identified as a dietary supplement, essential oil, homeopathic remedy or cosmetic that makes prohibited disease claims about pathogens such as bacteria, fungi, viruses, yeasts, protozoa, or microbes. These types of products that make disease claims are prohibited from sale and listing on Amazon. For additional guidance, please see: https://sellercentral.amazon.com/gp/help/help.html?itemID=201829010&language=en_US&ref=su_201829010_cont_200164330 and https://www.fda.gov/regulatory-information/search-fda-guidance-documents/small-entity-compliance-guide-structurefunction-claims. To be considered for reinstatement, you must (1) remove the prohibited disease claims from the detail page before appealing the restriction, and (2) upload a picture of the product's ingredient list to the detail page (such as the "Drug Facts" or "Supplement Facts" table). Please note that if the disease claim is on the product labeling, there may not be a path to reinstatement.

What actions do I need to take?

- Please see policy information beneath the listing at issue in your Account Health page for any other relevant actions or information required to bring product into compliance.

- If you believe the product(s) listed above are permitted for sale on Amazon, you can submit a dispute by following these steps:

1. Go to "Account Health" in Seller Central.

2. Click "Appeal" next to the violation at issue.

To view your account performance, go to "Account Health": https://sellercentral.amazon.com/performance/dashboard?reftag=ah_em_rp or select "Account Health" on the home screen of the Amazon Seller app on your iOS or Android device. The Account Health dashboard shows how well your account is performing in light of the metrics and policy compliance standards required to sell on Amazon.

We're here to help.

If you have questions about our restricted products policy, refer to:

Restricted products: https://sellercentral.amazon.com/gp/help/G200164330

Listing restrictions: https://sellercentral.amazon.com/gp/help/G200832300

Restricted Products FAQ: https://sellercentral.amazon.com/gp/help/GCYAVS22E6CQKV2B

- We are expanding notifications that let you know about issues before they impact your ability to sell. If you have additional questions, contact Selling Partner Support: https://sellercentral.amazon.com/cu/contact-us.

- Download iOS App at https://itunes.apple.com/us/app/amazon-seller/id794141485?mt=8

- Download Android App at https://play.google.com/store/apps/details?id=com.amazon.sellermobile.android&hl=en_US

We appreciate your cooperation and thank you for selling on Amazon.

Amazon Services

Note: This e-mail was sent from a notification-only address that cannot accept incoming e-mail. Do not reply to this message.

Here are the Amazon Rules for

Cosmetics and Skin and Hair care

Important: If you supply products for sale on Amazon, you must comply with all federal, state, and local laws and Amazon policies applicable to those products and product listings.

Cosmetics are products that are usually rubbed, poured, sprinkled, or sprayed onto the body for cleansing, beautifying, or changing the appearance of the body. The cosmetics category includes products like skin creams, perfumes, lipsticks, fingernail polishes, temporary tattoos, eye and facial makeup, shampoos, hair colors, toothpastes, and deodorants.

Use the checklist below to help ensure that your products are compliant with Amazon’s policies.

Compliance Checklist

Packaging

• Cosmetics must be sealed in the original manufacturer’s packaging.

• Cosmetics must be new and unused.

• Cosmetics must clearly display identifying codes placed on the packaging by the manufacturer or distributor, such as matrix codes, lot numbers, or serial numbers.

Labeling and product detail pages

Cosmetics labels and detail pages must be labeled in English with the following information:

• The name of the product

• The purpose or use of the product (such as cleansing the body, reducing the appearance of wrinkles, moisturizing the skin)

• The amount of content of the cosmetic, in terms of weight, measure, count or a combination (such as 30 oz, 5 mL, 10 pills, 5 lb)

• The ingredient list

• The name and address of the manufacturer, packer, or distributor (this is not required on detail pages)

• Any necessary label warnings

Cosmetic labels and detail pages must not:

• State that the products cure, mitigate, treat, or prevent a disease in humans, unless that statement is approved by the FDA and the product is properly labeled as both a cosmetic and a drug

• State that the cosmetics are “FDA approved” if they are not FDA approved

• Use the FDA logo

• State “tester,” “not for retail sale,” or “not intended for resale” as such items may not be sold on Amazon

For more information, go to the US Food and Drug Administration's resources:

• Summary of Labeling Requirements

• Cosmetics Labeling Claims

• Is It Really 'FDA Approved?'

• Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?).

Products and ingredients

• Cosmetics must not be named in an FDA recall or safety alert (for more information, go to: Recalls, Market Withdrawals, & Safety Alerts)

• Cosmetics must not contain prohibited ingredients (for more information, go to: Prohibited & Restricted Ingredients)

• Cosmetics must be safe for use and must not be a product that the Food and Drug Administration (FDA) has determined presents an unreasonable risk of injury or illness, such as:

  • Products that contain methylene glycol, which, when heated, release formaldehyde into the air (for more information, go to: Hair-Smoothing Products That Release Formaldehyde When Heated)

  • Eyelash and eyebrow permanent dye (for more information, go to: Use Eye Cosmetics Safely)

  • Eye makeup containing Kohl, Kajal, Al-Kahal, or Surma (for more information, go to Use Eye Cosmetics Safely)

  • Skin creams containing mercury (for more information, go to: Mercury Poisoning Linked to Skin Products)

  • Henna products designed or marketed for body-decorating or any other variation of direct skin application (for more information, go to: Cosmetics Safety Q&A: Tattoos and Permanent Makeup)

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• Cosmetics must not require a prescription or a medical professional's supervision or direction for their use

• Cosmetics must not contain controlled substances, such as:

  • Anything listed in Schedules I, II, III, IV or V of the Controlled Substances Act (for more information, go to: Schedules of Controlled Substances)

  • "List I" chemicals or their derivatives as designated by the Drug Enforcement Administration (DEA) (for more information, go to: List I and List II Chemicals)

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• Cosmetics must not contain plastic microbeads (for more information, go to: The Microbead-Free Waters Act: FAQ)

• In order to be sold into California and New York, antiperspirants, deodorants, and hairsprays must not contain toxic air contaminants (for more information, go to: California Air Resources Board Consumer Products Enforcement and New York Department of Environmental Conservation)

• Cosmetics must comply with Amazon policies, including:

  • Cosmetics that contain ingredients derived from sharks, whales, dolphins, or porpoises are prohibited from sale.

  • Cosmetics that contain more than 12% hydrogen peroxide are prohibited from sale.

  • Cosmetics that contain acetone, such as nail polish remover, cannot be sold in volumes more than 16 oz in total.

  • InStyler rotating irons are prohibited from sale.

  • Claire’s brand cosmetics are prohibited from sale.

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Known prohibited products

Amazon specifically prohibits the following cosmetic products. These products are prohibited because they do not meet the checklist requirements. This list does not include all cosmetic products prohibited by Amazon.

• Corrective and cosmetic contact lenses

• Latisse

• Obagi Nu-Derm Sunfader

• Obagi Nu-Derm Clear

• Obagi Nu-Derm Blender

• Obagi Elastiderm Decolletage Skin Lightening Complex

• Obagi C-Therapy Nightcream

• Obagi RX System Clarifying Serum

• Products that contain minoxidil in excess of 5%

• Bithionol

• Brazilian Blowout Acai Professional Smoothing Solution

• Chloroform

• Halogenated salicylanilides

• Methylene chloride

• Vinyl chloride in aerosol products

• Zirconium-containing complexes in aerosol products

• Synthol, Synthrol, or Swethol posing oil

• Trichloroacetic Acid

Example of Amazon jurisdictional restrictions

You must also comply with state and local laws applicable to the jurisdiction into which your products are sold, as well as the jurisdiction from which you ship. An example of a jurisdictionally restricted product includes sunscreen containing oxybenzone or octinoxate

FDA's Prohibited Ingredients List

(From the FDA website)

What ingredients are prohibited or restricted by FDA regulations?

Although it’s against the law to use any ingredient that makes a cosmetic harmful when used as intended, FDA has regulations that specifically prohibit or restrict the use of the following ingredients in cosmetics:

• Bithionol. The use of bithionol is prohibited because it may cause photocontact sensitization (21 CFR 700.11).

• Chlorofluorocarbon propellants. The use of chlorofluorocarbon propellants in cosmetic aerosol products intended for domestic consumption is prohibited (21 CFR 700.23).

• Chloroform. The use of chloroform in cosmetic products is prohibited because it causes cancer in animals and is likely to be harmful to human health, too. The regulation makes an exception for residual amounts from its use as a processing solvent during manufacture, or as a byproduct from the synthesis of an ingredient (21 CFR 700.18).

• Halogenated salicylanilides (di-, tri-, metabromsalan and tetrachlorosalicylanilide). These are prohibited in cosmetic products because they may cause serious skin disorders (21 CFR 700.15).

• Hexachlorophene. Because of its toxic effect and ability to penetrate human skin, hexachlorophene (HCP) may be used only when no other preservative has been shown to be as effective. The HCP concentration in a cosmetic may not exceed 0.1 percent, and it may not be used in cosmetics that are applied to mucous membranes, such as the lips (21 CFR 250.250).

• Mercury compounds. Mercury compounds are readily absorbed through the skin on topical application and tend to accumulate in the body. They may cause allergic reactions, skin irritation, or neurotoxic problems. The use of mercury compounds in cosmetics is limited to eye area products at no more than 65 parts per million (0.0065 percent) of mercury calculated as the metal and is permitted only if no other effective and safe preservative is available. All other cosmetics containing mercury are adulterated and subject to regulatory action unless it occurs in a trace amount of less than 1 part per million (0.0001 percent) calculated as the metal and its presence is unavoidable under conditions of good manufacturing practice (21 CFR 700.13).

• Methylene chloride. It causes cancer in animals and is likely to be harmful to human health, too (21 CFR 700.19).

• Prohibited cattle materials. To protect against bovine spongiform encephalopathy (BSE), also known as "mad cow disease," cosmetics may not be manufactured from, processed with, or otherwise contain, prohibited cattle materials. These materials include specified risk materials*, material from nonambulatory cattle, material from cattle not inspected and passed, or mechanically separated beef. Prohibited cattle materials do not include tallow that contains no more than 0.15 percent insoluble impurities, tallow derivatives, and hides and hide-derived products, and milk and milk products** (21 CFR 700.27).

• Sunscreens in cosmetics. Use of the term "sunscreen" or similar sun protection wording in a product's labeling generally causes the product to be subject to regulation as a drug or a drug/cosmetic, depending on the claims. However, sunscreen ingredients may also be used in some cosmetic products to protect the products’ color. The labelling must also state why the sunscreen ingredient is used, for example, "Contains a sunscreen to protect product color." If this explanation isn’t present, the product may be subject to regulation as a drug (21 CFR 700.35). For more information on sunscreens, refer to Tanning Products.

• Vinyl chloride. The use of vinyl chloride is prohibited as an ingredient of aerosol products, because it causes cancer and other health problems (21 CFR 700.14).

• Zirconium-containing complexes. The use of zirconium-containing complexes in aerosol cosmetic products is prohibited because of their toxic effect on lungs of animals, as well as the formation of granulomas in human skin (21 CFR 700.16).

What about color additives?

• Color additives are permitted in cosmetics only if FDA has approved them for the intended use. In addition, some may be used only if they are from batches that FDA has tested and certified. To learn more, see “Color Additives and Cosmetics.”

What about drug ingredients?

If a product is intended for a therapeutic purpose, such as treating or preventing disease, it’s a drug under the law and must meet those requirements, such as premarket approval by FDA, even if it affects the appearance. The presence of certain ingredients with a therapeutic use that is well-known to the public and industry is one factor that can determine whether a product is intended for use as a drug. FDA makes these decisions on a case-by-case basis. To learn more, see “Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?).”

Why are different ingredients prohibited in some other countries?

Different countries and regions regulate cosmetics under different legal frameworks.

Under U.S. law, FDA does not have the authority to require cosmetic manufacturers to submit their safety data to FDA, and the burden is on FDA to prove that a particular product or ingredient is harmful when used as intended. We make these decisions based on reliable scientific information available to us. FDA can take other countries’ decisions into consideration, but we can only take action within the legal and regulatory framework for cosmetics in the United States.