Mental Health And Sleep Disorder Claims

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Mental Health And Sleep Disorder Claims

 

Few people are aware of the connection between nutrition and depression while they easily understand the connection between nutritional deficiencies and physical illness. Depression is more typically thought of as strictly biochemical-based or emotionally-rooted. On the contrary, nutrition can play a key role in the onset as well as severity and duration of depression.[1]

This is the reason why many Amazon sellers took advantage of providing dietary supplements that claim to cure, treat, mitigate or prevent depression and other mental health disorders. Sellers can put mental health disorder symptoms and treatments because they are not part of the disease types/claims in Dietary Supplement Health and Education Act of 1994[2].

Nevertheless, Amazon’s legal team took action and put restrictions on dietary supplements that claim to cure, treat, mitigate or prevent depression and other mental health disorders after 10 companies received warning letter from FDA for illegally selling such dietary supplements in February, 2021[3].

It’s fairly new and there are no current or updated Amazon articles that discloses about mental health disorders. If ever you receive a violation notification, Amazon will direct you to the Dietary Supplements article.

Remember:

Canada has different ways of natural health products (NHP) regulations under Health Canada’s supervision.

Restricted Product Policy Violations Details:

The violation details are located under “Reason” in Restricted Product Policy Violations in Account Health Performance.

This product has been identified as a dietary supplement or cosmetic that claims to treat, cure, or prevent a disease related to a mental health disorder and will not be considered for reinstatement unless the seller removes all prohibited disease claims from the product detail page and product images. Please note that if the disease claim is on the product labeling, there may not be a path to reinstatement.

Mental Health Disorder Claims

The following claims are mental health disorder claims but not limited to:

  • Depression/depressed

  • Anxiety

  • Stress

  • Bipolar disorder

  • Obsessive-compulsive disorder (OCD)

  • Schizophrenia

  • Mood boosting

  • Calm

  • Autism

  • Attention deficit disorder/attention deficit hyperactivity disorder (ADD/ADHD)

How to Fix?

Document the changes/actions you will take.

  1. Check the product images and remove the prohibited claims from infographics.

  2. Download a category listing report (CLR) and remove all prohibited claims from the following attributes.

    1. Title

    2. Description

    3. Bullet points

    4. Search terms

    5. Intended Use

    6. Other Attributes

  3. Upload the updated CLR and take the batch ID.

  4. Go to A+ contents and look for the ASIN. Remove the prohibited claims from description, images and alt text keywords.

  5. If you’re confident that everything is set, go to Performance > Account Health > Restricted Product Policy Violations > Look for the ASIN > Appeal > Check the 2 boxes and Submit. Wait 24 hours before the listing gets reinstated.

What if the listing remained yanked?

  1. Send a ticket. Follow this pathway Help > Get Support > Selling on Amazon > Or, browse for your issue in the menu > Products, Listings, or Inventory > Inventory file upload issue.

  2. Title/Reason: “US - Restricted Products - Appeal - ASIN: B0xx”

  3. Body (the following is just an example, please don’t copy but tweak it depending on the actions you took).

Greetings,

We’re sorry that you yanked ASIN B0xx because you identified it as a dietary supplement or cosmetic that claims to treat, cure, or prevent a disease related to a mental health disorder.

We thoroughly checked the listing and removed the following claims (batch ID: xxx).

Title:

Depression

Description:

Anxiety

Bullet 1:

Mood boosting

Please reinstate the listing. Send this to the internal team for further review and reinstatement.

Get the case ID and monitor the updates.

Note:

Supplement Facts/Ingredients List of the product should be present in the product images for faster reinstatement.

Sleep Disorder

As it turns out, there’s quite a bit of truth behind this colloquial saying. Sleep is closely connected to mental and emotional health and has demonstrated links to depression, anxiety, bipolar disorder, and other conditions.[4]

Americans are notoriously sleep deprived, but those with psychiatric conditions are even more likely to be yawning or groggy during the day. Chronic sleep problems affect 50% to 80% of patients in a typical psychiatric practice, compared with 10% to 18% of adults in the general U.S. population. Sleep problems are particularly common in patients with anxiety, depression, bipolar disorder, and attention deficit hyperactivity disorder (ADHD).[5]

Restricted Product Policy Violations Details:

This product has been identified as claiming to be a treatment, cure, or remedy for a sleep disorder. Products marketed as arthritis treatments, remedies, cures, or similar arthritis related products are prohibited unless they have been approved by the FDA. To be considered for reinstatement, please remove the prohibited disease claim from the detail page and appeal the restriction. Please note that if the disease claim is on the product labeling, there may not be a path to reinstatement.

Sleep Disorder Claims

The following claims are mental health disorder claims but not limited to:

  • Sleep

  • Insomnia

  • Rest

How to fix it?

Please see “How to Fix?”

What if the listing remained yanked?

(See the steps above but the Plan of Action (PoA) is slightly different)

Greetings,

We’re sorry that you yanked ASIN B0xx because you identified it claiming to be a treatment, cure, or remedy for a sleep disorder.

We thoroughly checked the listing and removed the following claims (batch ID: xxx).

Title:

Sleep

Description:

Insomnia

Bullet 1:

Rest

Please reinstate the listing. Send this to the internal team for further review and reinstatement.

Psychoactive/Hallucinogenic Plant

Recently, Amazon's legal team prohibits the sale of hallucinogenic plant compounds because of their mental health disorder treatment claims that are not yet tested by the FDA. There’s no current list of these ingredients/compounds.

So far, I’ve ran into 2 ingredients/compounds that have been identified as Psychoactive/Hallucinogenic Plant:

  • Tetrahydroharmine (THH)

  • Kanna

For more information, please visit this article.

  1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2738337/ ↑

  2. https://ods.od.nih.gov/About/DSHEA_Wording.aspx ↑

  3. https://www.fda.gov/news-events/press-announcements/fda-warns-10-companies-illegally-selling-dietary-supplements-claiming-treat-depression-and-other ↑

  4. https://www.sleepfoundation.org/mental-health ↑

  5. https://www.health.harvard.edu/newsletter_article/sleep-and-mental-health ↑

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