WARNING LETTER
Blue Poppy Enterprises Inc
MARCS-CMS 614126 —
August 06, 2021
Delivery Method:
Overnight Delivery
Product:
Drugs
Recipient:
Recipient Name
Young Li
Recipient Title
Owner
Blue Poppy Enterprises Inc
4804 SE 69th Avenue
Portland
,
OR
97206
United States
Issuing Office:
Division of Human and Animal Food Operations West VI
United States
August 6, 2021
CMS 614126
WARNING LETTER
Dear Mr. Li:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.peoplesherbs.com in June and August 2021, and has determined that you take orders there for the products Modified Perilla & Mentha, Empowered Cordyceps, Empowered Reishi, AllerEase, Empowered Eleuthro, Sui Bian Guo, Chinese Herbal Shampoo, Jade Dew Ointment, Stop Pain Tincture, Dr. Bob’s Medicated Oil, Cut & Sore Ointment, E-C-Z Ointment, Organic Cactus Seed (Prickly Pear) Oil Antioxidant Facial Serum, Skin Soothing Ointment, and Dragon’s Blood Liniment. We have also reviewed your website at Internet address www.bluepoppy.com, which you link to your website www.peopleherbs.com, your Amazon Marketplace webpage, and three of your social media websites. Your social media sites https://www.facebook.com/ PeoplesHerbs/ and https://twitter.com/peoples herbs?lang=en direct consumers to your product website, www.peoplesherbs.com, where products can be purchased. Additionally, your Instagram feed is accessible from your main page on your website www.peoplesherbs.com.
The claims on your websites and social media pages establish that your products are drugs 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 they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing, or delivering these products 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 website claims that provide evidence that your products are intended for use as drugs include:
Modified Perilla & Mentha
On your webpage for Modified Perilla & Mentha at www.peoplesherbs.com:
“CHINESE MEDICAL DIAGNOSIS: Gu chong (gu worms) leading to xie xie (diarrhea), xia li (dysentery), xiao fu tong (lower abdominal pain)…”
“PATTERN DISCRIMINATION: Spleen qi vacuity with stomach and intestinal dampness and heat complicated by liver depression, stomach fluid dryness, and heart qi and blood vacuity”
“THERAPUTIC[sic] ACTIONS:…combats gu and kills worms.”
“INDICATIONS: This formula is for spleen qi vacuity with stomach and intestinal dampness and heat complicated by liver depression, stomach fluid dryness, and heart qi and blood vacuity. In terms of disease indications, it treats gu parasites with abdominal distention, loose stools or diarrhea, and abdominal cramping. Patients with this scenario have usually been diagnosed as suffering from intestinal parasites, intestinal dysbiosis, candidiasis, leaky gut syndrome, food allergies, and/or hypoglycemia. They may have irritable bowel syndrome, Crohn’s disease, ME, or chronic allergic rhinitis/sinusitis.”
On the Modified Perilla & Mentha webpage found at www.bluepoppy.com:
“…[W]idely applicable in cases of various types of digestive weakness that include a history of multiple parasitic infections.”
“Consider in cases of spleen qi vacuity with intestinal damp heat complicated by liver depression, stomach dryness, heart qi and blood vacuity.”
Empowered Cordyceps
On your webpage for Empowered Cordyceps at www.peoplesherbs.com:
“Cordyceps has significant health benefits including being one of the best substances an asthmatics can include in their diet; a well-regarded tonic to help with recovery from long-term or significant illnesses…”
“Cordyceps is also regarded traditionally as a recovery tonic. In China it is often employed to help people recover from long-term or significant illnesses…It is thought to have a particularly strengthening effect on kidney and lung function.”
“Sexual debility is an ever-increasing issue in modern life. One need only watch television to note the many drug ads for pills to elevate sexual performance. In the U.S. it is estimated that 5% of 40 year-old men and 15-25% of 65 year old men have erectile dysfunction. This is another area, along with its role on the training table of athletes, where demand is driving the overharvesting. The sex drive is so central to one’s sense of well-being that people will pay a king’s ransom for a product that holds out hope for remedying the loss of sexual vitality. And Chinese studies do seem to indicate there is some hope for help with Cordyceps, even when consumed in a modest dose.”
Additionally, similar claims are present on your Amazon Marketplace product webpage.
Empowered Reishi
On your webpage for Empowered Reishi at www.peoplesherbs.com:
“Reishi…can help with…support role with various types of cancer…”
“…[H]elp with blood sugar regulation.”
“…Reishi is valued world-wide for its use in a wide range of conditions. Clinically, Reishi is useful for symptoms of blood…deficiency…”
“…[B]eneficial action on blood sugar regulation.”
“…[A]nti-hypertensive properties. Hepatic fibrosis is also shown to be inhibited by [herbs in Reishi].”
On the Empowered Reishi webpage at www.bluepoppy.com, under the Detailed
Description:
“Reishi is useful for patients with symptoms of blood…deficiency . . ..”
On the Product Information Sheet, accessible to view from your Empowered Reishi product page, at www.bluepoppy.com:
“Other compound in reishi are shown in research to have beneficial action on blood sugar regulation.”
“…[A]nti-hypertensive properties. Hepatic fibrosis is also shown to be inhibited…”
“…[S]upportive role with various types of cancer, demonstrates neuro-protective actions…and reduces anxiety.”
Additionally, similar claims are present on your Amazon Marketplace product webpage. For example, at https://www.amazon.com/Empowered-Reishi-100-Capsules-Peoples/dp/B08YH1WXN2/ref=sr_1_1?dchild=1&keywords=Empowered+Reishi&qid=1627574049&sr=8-1:
“…Reishi is valued world-wide for its use in a wide range of conditions. Reishi is useful for those with symptoms of blood…deficiency…”
AllerEase
On your webpage for AllerEase at www.peoplesherbs.com:
“…[C]lear, runny nose and stuffed nose.”
“CHINESE DISEASE DIAGNOSIS…
Bi liu ti
(runny nose),
pen ti
(sneezing),
bi se
(nasal congestion),
bi yang
(itchy nose),
mu yang
(itchy eyes)”
“PATTERN DISCRIMINATION…insufficient spleen (and possibly kidney) vacuity with deep-lying phlegm rheum.”
“THERAPEUTIC ACTIONS…eliminates dampness and transforms phlegm, stops itching and opens the flow of the nasal orifices”
“INDICATIONS…For acute episodes of allergic rhinitis characterized by clear, runny, itchy nose, itchy eyes, and sneezing…spleen (and possibly kidney) vacuity with deep-lying phlegm rheum.”
On the Product Information Sheet, accessible from your AllerEase product page at www.peoplesherbs.com:
“…[C]lear, runny nose and stuffed nose.”
“CHINESE DISEASE DIAGNOSIS
Bi liu ti
(runny nose),
pen ti
(sneezing),
bi se
(nasal congestion),
bi yang
(itchy nose),
mu yang
(itchy eyes)”
“PATTERN DISCRIMINATION…insufficient spleen (and possibly kidney) vacuity with deep-lying phlegm rheum.”
“THERAPEUTIC ACTIONS…eliminates dampness and transforms phlegm, stops itching and opens the flow of the nasal orifices”
“INDICATIONS The remedial treatment of acute episodes of allergic rhinitis characterized by clear, runny, itchy nose, itchy eyes, and sneezing…spleen (and possibly kidney) vacuity with deep-lying phlegm rheum.”
“FORMULATOR’S COMMENTS …not so likely to cause excessive dryness of the mucus membranes as does prolonged use of Western medical anticongestants.”
“THE SIGNS AND SYMPTOMS OF WIND COLD ALLERGIC RHINITIS INCLUDE…Episodic or seasonal sneezing due to airborne allergens…Clear, watery runny nose…Itchy nose…Itchy eyes…Nasal congestion”
“THE SIGNS AND SYMPTOMS OF SPLEEN VACUITY INCLUDE…An enlarged tongue with teeth-marks on its edges and white fur…A possible soggy pulse…Possible loose stools…”
“In Chinese medicine, people who contract airborne allergies…mostly due to a chronically vacuous and weak spleen failing to engender the lungs…there may also be a kidney qi vacuity…obstruct the lungs’ diffusion and downbearing… tendency to phlegm dampness…whenever the lungs’ diffusion and downbearing of fluids is inhibited, this phlegm…becoming apparent as mucus.”
“…[T]his formula…secure the lungs and specifically stop[s] runny nose…open the orifices and free the flow of the nose, thus relieving nasal con- gestion…stops itching…seeps dampness via urination and, therefore…eliminate dampness…helping fortify the spleen…”
Empowered Eleuthro
On your webpage for Empowered Eleuthro at www.peoplesherbs.com:
“Chronic infections”
“Declining eyesight”
“Chronic inflammatory condition”
“…[H]elp with…deficiency without creating unwanted side-effects…for given complaints…With Red Rice Yeast Plus for patients who have minor lipid problems.”
On your blog posting All About Eleuthro from www.peoplesherbs.com:
“…[F]ormulated to help with…deficiency without creating unwanted sideeffects…”
“…[T]hought to have a therapeutic focus on lungs, spleen, and kidneys. It can be of use in conditions of joint stiffness and pain…”
“…[F]or those minor cholesterol problems”
“Chronic infections”
“Declining eyesight”
“Chronic inflammatory conditions”
Sui Bian Guo
On your webpage for Sui Bian Guo at your, www.peoplesherbs.com:
“…[R]elieving constipation…”
“Mulberry leaf powder…has the functions of resisting bacteria, removing toxicity…”
“Mate tea…is a regulator of the heart, nerves and muscles that can prevent the deterioration of body function;…scavenging cholesterol...”
“Dietary fiber…prevent[s] constipation and hemorrhoids...Dietary fiber can reduce…cholesterol absorption in the gut and promote the discharge of cholesterol and cholic acid, with an effect of reducing…blood fat, and cholesterol.”
“Beta-Carotene…improving nyctalopia, human immunity…”
Additionally, similar claims are present on your product webpage at www.bluepoppy.com; and your Twitter and Facebook webpages, which offer direct links to your www.peoplesherbs.com webpage. These include but are not limited to the following on your Twitter webpage:
“…[E]xcellent for relieving constipation…resisting bacteria…”
And the following on your Facebook webpage:
“…[E]xcellent for relieving constipation…resisting bacteria…”
“…[P]opular remedy for constipation…”
Chinese Herbal Shampoo
On your webpage for the product Chinese Herbal Shampoo, at www.peoplesherbs.com and www.bluepoppy.com:
“…[Q]uickens the blood in the scalp.”
“…[A]nti-inflammatory, bacteriostatic, and bacteriocidal… also helps in tissue regeneration.”
“…[E]liminate dandruff…”
Additionally, similar claims are present on your Amazon Marketplace product webpage.
Dragon’s Blood Liniment
On your webpage for Dragon’s Blood Liniment at www.peoplesherbs.com:
“This liniment is for blood stasis due to traumatic injury when there is pronounced pain and ecchymosis.”
“Quickens the blood and dispels stasis…disperses swelling, and stops pain.”
Similar claims are found on your Amazon Marketplace product webpage as well as your product’s web page at www.bluepoppy.com.
Jade Dew Ointment
On your webpage for Jade Dew Ointment at www.peoplesherbs.com:
“Clears heat and cools the blood, disperses swelling, and resolves toxins.”
“Recommended for cold sores (herpes simplex).”
“Use: Apply externally at the first sign of a cold sore…”
On the Jade Dew Ointment webpage at www.bluepoppy.com:
“[R]ecommend it for the treatment of herpes simplex in … ‘The Chinese Medical Treatment of Viral Diseases’”
“Clears heat and cools the blood, disperses swelling and resolves toxins”
Additionally, similar claims are present on your Amazon Marketplace product webpage.
Stop Pain Tincture
On your webpage for Stop Pain Tincture at www.peoplesherbs.com:
“…[Q]uickens the blood, and stops pain.”
“Appy externally to the site of pain.”
“Formula Rationale Hong Hua (Flos Carthami) is a blood-quickening medicinal. It quickens the blood and transforms stasis. Hong Hua is a commonly used medicinal…for both traumatological and impediment pain conditions…Gan Song Xiang…is [a]…medicinal…stops pain…arouse the spleen and clear away turbidity (when taken internally). In terms of its pain-stopping ability, this medicinal…has pronounced sedative and anodyne effects.”
“…[Alcohol] quickens the blood. Alcohol also potentizes the medicinal effects of other ingredients…is both a medium and an active ingredient in its own right.”
“…[E]very type of pain is due to some sort of non-free flow…distention, intermittent or movable pain, and gripping or cramping pain…intense, localized, sharp, stabbing pain…accompanied by swelling…or inflammation…main principles in Chinese medicine for treating any kind of pain…and quicken the blood…. pain automatically disappears. It is axiomatic in Chinese medicine that, “If there’s free flow; there is no pain.”
“…[D]iverse types of pain as tennis elbow, lumbar vertebral hyperplasia, lumbar disk protrusion, osteoarthritis arthritis, rheumatoid arthritis, dysmenorrhea, and stomach and duodenal ulcers…relief of pain…pain caused by traumatological injury…periarthritis…lumbar hyperplasia…dysmenorrhea…”
Dr. Bobs Medicated Oil
On your webpage for Dr. Bob’s Medicated Oil at www.peoplesherbs.com.
“Medicated Oil”
“…[P]roven healing power for all sorts of complaints…”
“…[Q]uickens the blood, disperses inflammation and stops pain and itching”
Similar claims are found on your Amazon Marketplace product webpage as well as your product’s web page at www.bluepoppy.com.
Cut & Sore Ointment
On your webpage for Cut & Sore Ointment at www.peoplesherbs.com:
“…[Q]uicken the blood and stop pain…engenders the flesh…clears heat and alleviates pain.”
“Clears heat and resolves toxins, moves the blood and stops pain, engenders flesh and eliminates putridity”
“Apply to open cuts or sores one or more times a day.”
Additionally, similar claims are present on your website www.bluepoppy.com.
E-C-Z Ointment
On your webpage for E-C-Z Ointment at www.peoplesherbs.com:
“For…eczema. Blue Poppy’s E-C-Z ointment clears heat and eliminates dampness, dispels wind, and stops itching.”
Organic Cactus Seed (Prickly Pear) Oil Antioxidant Facial Serum
On your webpage for Organic Cactus Seed (Prickly Pear) Oil Antioxidant Facial Serum at www.peoplesherbs.com:
“Regenerates the skin and slows down its aging process, thereby preventing wrinkles”
“Like argan oil itself, it can also be used directly for treating…scar tissue and fissures.”
Skin Soothing Ointment
On your webpage for Skin Soothing Ointment at www.peoplesherbs.com and posts March 26, 2021, on your https://www.facebook.com/ PeoplesHerbs/ and https://www.instagram.com/peoples_herbs/ social media sites:
“Blue Poppy’s Skin Soothing ointment is for topical application to burns and scalds. It clears heat and dries dampness, cools the blood and resolves toxins, quickens the blood and stops pain, transforms stasis and eliminates the putrid, closes sores and engenders flesh.”
Additionally, similar claims are present on your Instagram feed, accessible to view from your, www.peoplesherbs.com, webpage, as well as your Instagram, Twitter and Facebook webpages, as found at, https://www.instagram.com/peoples_herbs/, https://twitter.com/peoplesh erbs?lang=en, and https://www.facebook.com/ PeoplesHerbs/, respectively which offer direct links to your, www.peoplesherbs.com, website where products can be purchased.
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. With certain exceptions not applicable here, 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), § 355(a)]. FDA approves a new drug based on 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 products Modified Perilla & Mentha, Empowered Cordyceps, Empowered Reishi, Sui Bian Guo, and Stop Pain Tincture are 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 a layperson to use your products safely for their intended purposes. Accordingly, your Modified Perilla & Mentha, Empowered Cordyceps, Empowered Reishi, Sui Bian Guo, and Stop Pain Tincture products fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)].
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your response should be sent to the Food and Drug Administration, Attention: Amy R. Glynn, Compliance Officer, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021-4421. If you have any questions regarding this letter, please contact Compliance Officer Glynn at 425-302-0411.
Sincerely,
/S/
Miriam R. Burbach
District Director
Program Division Director
Content current as of:
09/28/2021
Regulated Product(s)
Drugs