Inspections, Compliance, Enforcement, and Criminal Investigations

www.poppyseedwash.com 7/12/18

 

  

Black HHS-Blue FDA Logo

 

 

 
10903 New Hampshire Avenue
Silver Spring, MD 20993 

 

WARNING LETTER
JUL 12, 2018
 
 
VIA EXPRESS DELIVERY AND ELECTRONIC MAIL
 
Devin Michael Tew
www.poppyseedwash.com
10102 S Redwood Rd
#95443
South Jordan, UT 84095
info@poppyseedwash.com
 
Re: CMS# 553349
 
Dear Mr. Tew:                                                                                   
                                   
This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address http://www.poppyseedwash.com and has determined that you take orders there for the product PoppySeed Wash. In addition, FDA reviewed your social media accounts and product label for PoppySeed Wash.  The claims on your product label and websites establish the product is a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)] because it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov
 
Examples of some of the product label claims that provide evidence that your PoppySeed Wash product is intended for use as a drug include: 
  • “Medicinal Uses for Tea: Pain relief; Sleep aid; Anxiety relief; Relaxant/sedative; Opioid rotation; Opioid withdrawls [sic]”
Examples of some of the website claims that provide evidence that your PoppySeed Wash product is intended for use as a drug include:
  • “Poppy seeds come from the opium poppy plant (Papaver Somniferum), which is one of the world’s oldest known medicines. The therapeutic use of the opium poppy predates recorded history making its benefits and side effects fairly well known and understood. Poppy seeds fall in the opioid drug class, which is any chemical that resembles morphine or other opiates in its pharmacological effects. Opioids work by binding to opioid receptors, which are found principally in the central and peripheral nervous system and the gastrointestinal tract. The receptors in these organ systems mediate the beneficial effects, the psychoactive effects, and the side effects of opioids. PoppySeed Wash is fast acting, typically bringing relief within thirty minutes to an hour for the following conditions:
    • Pain Relief – PoppySeed Wash suppress [sic] your perception of pain and calm your emotional response to pain by reducing the number of pain signals sent by the nervous system and the brain's reaction to those pain signals. It is important to remember that opioids only suppress pain….
    • Opioid Rotation – …Opioid rotation refers to a switch from one opioid to another in an effort to improve outcomes. There are several cycling strategies, but one could be taking a single day break from your regular opioid medication and using a bottle of PoppySeed Wash for that days [sic] pain. The next day you take a break from PoppySeed Wash and return to your original opioid. It will be stronger or you can use less of it for the same effects. Tolerance will still continue to build for both medications, but at a much slower pace with rotation.
    • Sleep Aid – The opioids relax and sedate the body ….
    • Anxiety Relief/Sedative – PoppySeed Wash relieves anxiety by slowing down the central nervous system and has a relaxing and calming effect on the mind and body. Because it works quickly, it can be effective during a panic attack or another overwhelming anxiety episode.”
  • Q: What kinds of chemically similar drugs can PoppySeed Wash rotate with or replace? A: Opiates: morphine, diacetylmorphine (heroin), codeine. Opioids: (opiates above), hydrocodone (lortab, norco, vicodin), oxycodone (percocet, oxycontin), demerol, fentanyl, buprenorphine (suboxone subutex), methadone.”
  • Q: What side effects are possible? A: Poppy seed tea has many of the same possible side effects that other opioids have including: drowsiness, dehydration respiratory depression, constipation and nausea.”
  • From the video titled “PoppySeed Wash Introduction Video”:
    • (0:00) – “PoppySeed Wash is a medicinal tea made from poppy seeds and water. It is most commonly used to relieve pain, help sleep, reduce anxiety, and as an alternative to more harmful opioids like pain pills.”
During this statement, the screen shows the following: “Medicinal Uses: Pain Relief; Sleep Aid; Anxiety Relief; Opioid Alternative; Opioid Withdrawals”
    • (0:29) – “Poppy seeds come from the poppy plant, scientifically known as Papaver somniferum, a plant used for thousands of years for its medicinal purposes….the raw material used to make pharmaceuticals.”
  • From the video titled “Video on how to make PoppySeed Wash”:
    • (0:15) – “And so when you first order PoppySeedWash, it comes in a standard post office box, like this, and it says it’s from ‘pswash’ so no one has any idea that there is medicine inside.”
    • (2:01) – “You can’t really use hot water because it will damage the medicinal alkaloids….”
    • (5:15) – “With one bottle, you actually get several washes. So the first wash is always going to be the best. It’s going to be the strongest. But there is still some medicinal tea left in this bottle.” 
Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of PoppySeed Wash for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include: 
  • “I was taking oxycodone for my chronic back pain until my doctor cut off all his pain patients because of fear of dea crackdowns. I was cut off without tapering and was in a really bad situation. I naturally got addicted to heroin because I needed something for the withdrawals and I didn't have any other options. Then a friend told me about Poppy Seed Wash. It helped me kick my pain pill and heroin habit. I would still be using heroin if it were not for my friend and poppy wash!”
  • “I have a prescription for percocet and I always run out before I can get my next refill. I would always feel completely miserable because of the withdrawals. My doctor would yell at me for even asking for an early refill. Now I just drink poppy seed wash at the end of the month and no longer stress out when I only have a few pills left.”
  • “My neighbor and I independently got into heroin …. Sometime after I started using poppy seeds and eventually weaned my way off the black … found out she had passed away from a heroin overdose. I think of her all the time and cry wondering if I could have saved her life by introducing her to poppy seeds. Because of this painful experience, I now try to share this option with others that are struggling with the same thing.” 
In addition, claims on PoppySeed Wash social media accounts, including Twitter (https://twitter.com/PoppyWash), Instagram (https://www.instagram.com/poppyseedwash/), and Tumblr (https://poppyseedwash.tumblr.com/), which all have links to your website http://www.poppyseedwash.com where your product can be purchased directly, provide further evidence that your PoppySeed Wash is intended for use as a drug. Examples of such claims include:
  • “PoppySeed Wash is a medicinal beverage, generically known as poppy seed tea.” (Twitter, Instagram, Tumblr)
  • “Poppyseeds [sic], the answer to a lot of peoples [sic] ailments. Do you have pain? Having trouble sleeping? Anxiety? Need to relax? Or even opiate rotation? WE ARE THE ANSWER” (Instagram, Tumblr)
  • “Each bottle contains 6 ounces of special, unwashed, unprocessed, organic opium poppy seeds (papaver somniferum) sources specifically for high medicinal content.” (Tumblr)
  • “We want to help everyone in need of pain relief and to help so many that have had to turn to hard drugs. There is an answer and it is this organic poppyseed tea.” (Instagram, Tumblr)
  • Poppy seeds come from the opium poppy plant (Papaver Somniferum), which is one of the world’s oldest known medicines. All parts of the plant (including the seeds) contain psychoactive alkaloids: morphine, codeine and thebane ….” (Tumblr) 
Your PoppySeed Wash product is not generally recognized as safe and effective for the above referenced use and, therefore, the product is a “new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. § 331(d) and 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. 
 
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353 (b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
 
Your PoppySeed Wash product is intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner.  Therefore, it is impossible to write adequate directions for use for a layperson to use your product safely for its intended purposes. Accordingly, your PoppySeed Wash product fails to bear adequate directions for its intended use and, therefore, the product is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction into interstate commerce of this misbranded drug violates of section 301(a) of the Act [21 U.S.C. § 331(a)].
 
The above violations are not meant to be an all-inclusive list of violations that exist in connection with your product or its labeling. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. You should take prompt action to correct all violations associated with the products you market, including the violations noted in this letter. Failure to promptly correct these violations may result in enforcement action without further notice, including seizure and/or injunction. 
 
We note that you do not have an address listed for your place of business in your product labeling. In response to this letter, we request that you provide a physical address for your place of business, where we can contact your firm. We also note that products that are lawfully marketed as drugs must include certain contact information on their label as required under 21 CFR 201.1.
 
Please notify this office in writing within fifteen (15) working days from your receipt of this letter as to the specific steps you have taken to correct the violations noted above. Your response should include any documentation that would assist in evaluating your corrections. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete all corrections within 15 working days, please explain the reason for the delay and the date by which each such item will be corrected. 
 
You should direct your written reply to Beth Tirio, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions regarding this letter, you may contact Ms. Tirio via email at beth.tirio@fda.hhs.gov.
 
 
Sincerely,
/S/ 
William Correll
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
US Food and Drug Administration
 

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