Blue Poppy Enterprises Inc
FDA issued a warning letter to Blue Poppy Enterprises Inc (owner Young Li) in August 2021 after reviewing the company's websites, Amazon listings, and social media pages for products including herbal formulas, ointments, tinctures, and topical oils. The agency determined that disease-treatment claims on these platforms — including claims to treat parasites, eczema, herpes simplex, erectile dysfunction, cancer, hypertension, and allergic rhinitis — rendered the products unapproved new drugs under the FD&C Act, and that several products were also misbranded for lacking adequate directions for use. FDA demanded a written response within 15 working days and warned that failure to comply could result in seizure or injunction.
Flagged claims (23)
Reishi…can help with…support role with various types of cancer…
…[A]nti-hypertensive properties. Hepatic fibrosis is also shown to be inhibited by [herbs in Reishi].
THERAPUTIC[sic] ACTIONS:…combats gu and kills worms.
Regenerates the skin and slows down its aging process, thereby preventing wrinkles
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.
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.
…[Q]uicken the blood and stop pain…engenders the flesh…clears heat and alleviates pain.
…[P]roven healing power for all sorts of complaints…
[R]ecommend it for the treatment of herpes simplex in … 'The Chinese Medical Treatment of Viral Diseases'
…[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…
Recommended for cold sores (herpes simplex).
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…
…[S]upportive role with various types of cancer, demonstrates neuro-protective actions…and reduces anxiety.
…[H]elp with blood sugar regulation.
…[A]nti-inflammatory, bacteriostatic, and bacteriocidal… also helps in tissue regeneration.
Chronic infections
For…eczema. Blue Poppy's E-C-Z ointment clears heat and eliminates dampness, dispels wind, and stops itching.
Chronic inflammatory condition
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.
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.
Like argan oil itself, it can also be used directly for treating…scar tissue and fissures.
Mulberry leaf powder…has the functions of resisting bacteria, removing toxicity…
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.
Required actions (3)
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.
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.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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