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Assignment 1: Reporting Unlawful Sales of Medical Products on the Internet
Assignment: Report essential oil marketing information currently in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) of 1938 for at least one of the reason(s) outlined in step 5 below. We are currently collecting reports meeting ALL of the following criteria:
*These companies have been currently selected due to their current investigation status by the FDA and the mass amount of information in violation they distribute. Trademarks belong to the respective owners.
Take Action: If the information you have found meets all three criteria, you may file a SPARTA report. Here's how:
First: Go here: http://www.fda.gov/Safety/ReportaProblem/ucm059315.htm
Next: Fill out the form found directly on that page. Follow these steps to complete the form:
Copy and paste from the appropriate violation below:
Names a disease: The marketing material specifically names a disease -
This information is in violation of the Federal Food, Drug, and Cosmetic Act due to essential oils being promoted for conditions that cause them to be drugs under section 201(g)(1)(B) of the FD&C Act [21 U.S.C. § 321(g)(1)(B)], because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
Dietary Supplements: Essential oils are being sold as dietary supplements -
This information is in violation of the Federal Food, Drug, and Cosmetic Act due to essential oils being promoted as dietary supplements. Under section 201(ff)(2)(A)(i) of the FD&C Act [21 U.S.C. § 321(ff)](2)(A)(i)], a dietary supplement is defined, among other things, as a product intended for ingestion. Topical products and other products that are not intended for ingestion are not dietary supplements.
6. Enter at least one piece of contact information as requested to complete the form:
If you are a registered SPARTAN, you may use the following as your identification to file anonymously with the FDA:
7. Fill in the requested "CAPTCHA" at the bottom of the form, and click "SUBMIT FORM"
Finally: Report back! Send an email to us at [email protected]. Include:
ONCE YOU REPORT BACK AND YOUR REPORT IS VERIFIED FOR ACCURACY, YOUR REPORT WILL BE OFFICIALLY DOCUMENTED AS A "SPARTA" REPORT!
Otherwise it will just count as your own personal report, which still helps. But to help track and fine-tune the effectiveness of the SPARTA campaign, please report back!
Reports not following the outline listed above may not be counted as an official report by SPARTA.
Fraudulently using SPARTA's information without permission may be subject to legal penalties as determined by the SPARTA campaign and/or the US FDA.
- Online information on Young Living* or doTerra* brand pure essential oils or essential oil blend that,
- Violates the FD&C Act for at least one of the reason(s) as listed in step 5 below and,
- Directly associates the information in violation with a product available for immediate purchase.
*These companies have been currently selected due to their current investigation status by the FDA and the mass amount of information in violation they distribute. Trademarks belong to the respective owners.
Take Action: If the information you have found meets all three criteria, you may file a SPARTA report. Here's how:
First: Go here: http://www.fda.gov/Safety/ReportaProblem/ucm059315.htm
Next: Fill out the form found directly on that page. Follow these steps to complete the form:
- Website Address (URL) You are Reporting: Direct link to the information in violation.
- Date You Visited this Website
- Owner of Website: If you're not sure, check the footer at the bottom of the webpage to see to whom the page is copyrighted. If still unsure use the website's title.
- Street Address of the Website: Physical location of the website's owner. Again, try finding this info in the footer at the bottom of the webpage, or on the page's "About Us" or "Contact Us" links. If you are unable to locate one, just leave this field blank.
- Problem or Concern about this Website: Address the following four bullet points -
- Begin this section with the COMPLETE website address if it did not fit into step 1 (which is typical - be sure to check!).
- Select the proper violation below. You may copy and paste the information into your report:
Copy and paste from the appropriate violation below:
Names a disease: The marketing material specifically names a disease -
This information is in violation of the Federal Food, Drug, and Cosmetic Act due to essential oils being promoted for conditions that cause them to be drugs under section 201(g)(1)(B) of the FD&C Act [21 U.S.C. § 321(g)(1)(B)], because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
Dietary Supplements: Essential oils are being sold as dietary supplements -
This information is in violation of the Federal Food, Drug, and Cosmetic Act due to essential oils being promoted as dietary supplements. Under section 201(ff)(2)(A)(i) of the FD&C Act [21 U.S.C. § 321(ff)](2)(A)(i)], a dietary supplement is defined, among other things, as a product intended for ingestion. Topical products and other products that are not intended for ingestion are not dietary supplements.
- Include specific details and screenshots, if possible.
- If room permits, include the following: The violation(s) cited in this report are not intended to be an all-inclusive list of violations that exist in connection with this product.
6. Enter at least one piece of contact information as requested to complete the form:
If you are a registered SPARTAN, you may use the following as your identification to file anonymously with the FDA:
- First Name: Enter your "SPARTAN ID"
- Email: [email protected]
7. Fill in the requested "CAPTCHA" at the bottom of the form, and click "SUBMIT FORM"
Finally: Report back! Send an email to us at [email protected]. Include:
- Website URL you reported
- SCREENSHOTS of the information in violation if at all possible
- The date you filed your report
- Your SPARTAN ID
- Please copy and paste the first sentence of text on the page you see after you click "SUBMIT FORM", that begins, "Thank you..."
ONCE YOU REPORT BACK AND YOUR REPORT IS VERIFIED FOR ACCURACY, YOUR REPORT WILL BE OFFICIALLY DOCUMENTED AS A "SPARTA" REPORT!
Otherwise it will just count as your own personal report, which still helps. But to help track and fine-tune the effectiveness of the SPARTA campaign, please report back!
Reports not following the outline listed above may not be counted as an official report by SPARTA.
Fraudulently using SPARTA's information without permission may be subject to legal penalties as determined by the SPARTA campaign and/or the US FDA.
'All know what is right, but only the Spartans do it.'