WARNING LETTER
New Leaf Pharmaceuticals, LLC
MARCS-CMS 609744 —
December 22, 2020
Delivery Method:
Via Email
Product:
Drugs
Recipient:
Recipient Name
Paul Carpenter/Rod Deraney
New Leaf Pharmaceuticals, LLC
77 South Main Street
Newton
,
CT
06470
United States
info@newleafpharma.com
p.carpenter@sinolusa.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
WARNING LETTER
December 22, 2020
RE: 609744
Dear Messrs. Carpenter & Deraney:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at www.newleafpharma.com in July 2020 and determined that you took orders there for “RHINODOL CBD” nasal spray products (offered in 500 and 1000 mcg strengths), which you promote as products containing cannabidiol (CBD). We also reviewed your Facebook page at www.facebook/CBDMedicalProducts/, in July and December 2020, which directs consumers to your website at www.newleafpharma.com to purchase your products. The claims on your website and Facebook page establish that your “RHINODOL CBD” products
are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a). The introduction or delivery for introduction into interstate commerce of an unapproved new drug violates section 301(d) of the FD&C Act, 21 U.S.C. 331(d). Furthermore, these products are misbranded drugs under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1).
These products are especially concerning from a public health perspective because intranasal drug products may be rapidly absorbed through the highly vascularized nasal mucosa directly into systemic blood circulation, where they may exert undesirable systemic effects such as increased heart rate or elevated blood pressure. If toxic substances are introduced directly into the nose, harmful local effects such as bleeding, ulceration, or nasal septal perforation may occur.
As explained further below, introducing or delivering these products for introduction into interstate commerce violates the FD&C Act. You can find the FD&C Act and FDA regulations through links on FDA’s home page at
www.fda.gov
. You can find specific information about how FDA regulates CBD at
https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd
.
Unapproved New Drugs
Based on our review of
your website and
Facebook page
, your
“RHINODOL CBD" products
are
drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body.
Examples of claims observed on your Facebook page at www.facebook/CBDMedicalProducts/ in July and December 2020 that establish
the intended use of your products as drugs include, but may not be limited to, the following:
On your Facebook page at http://www.facebook/CBDMedicalProducts/:
From a post on November 28, 2019: "Multiple recent studies have shown that CBD can help with PTSD symptoms, such as having nightmares and replaying negative memories.”
From a post on November 15, 2019: “Rheumatoid Arthritis patients are discovering the benefits of CBD to address their symptoms with few (if any) side effects.
Inflammation . . .CBD interacts with receptors in the body’s endocannabinoid system to reduce inflammation
Pain . . . Several studies have shown a significant decrease in joint pain and chronic pain for users of CBD
CBD’s anti-inflammatory effects can slow the progression of RA, reducing permanent damage to joints.
As an auto immune disorder, Rheumatoid Arthritis is positively affected by CBD’s proven ability to reduce inflammation”
From a post on October 7, 2019: “Reduces Risk of Artery Blockage”
Examples of claims observed on your website www.newleafpharma.com in July 2020 that established the intended use of your products as drugs include, but may not be limited to, the following:
In the product descriptions for your “RHINODOL CBD” nasal spray products on www.newleafpharma.com:
“PAIN & INFLAMMATION”
“NERVOUSNESS (ANXIETY)”
“SLEEPLESSNESS”
“MYALGIA”
“CONGESTION”
In a section titled “FAQs” on www.newleafpharma.com:
“What are the potential medical benefits of CBD? . . .
Anti-emetic. Reduces nausea and vomiting.
Anti-convulsant Suppresses seizure activity.
Anti-psychotic. Combats psychosis disorders.
Anti-oxidant. Combats neurodegenerative disorder.
Anti-tumoral/Anti-cancer Combats tumor and cancer cells
Anxiolytic/Anti-depressant Combats anxiety and depression”
On a page entitled “CBD as a Treatment for Arthritis” on www.newleafpharma.com:
“Cannabinoids have been shown in studies to ease pain associated with conditions like cancer and multiple sclerosis.”
In “a study examining whether CBD could prevent joint neuropathy (general disease or malfunctions of the nerves and osteoarthritis . . . CBD was seen to decrease joint inflammation and serve to protect the nerves from further damage.”
“And what about Rheumatoid arthritis or RA, the autoimmune disorder that causes chronic inflammation in the joints and other body systems such as the skin, eyes, lungs, heart and blood vessels? . . . cannabis-based medication significantly improved pain and reduced inflammation in study participants.”
On a page entitled “CBD for Pain Relief” on www.newleafpharma.com:
“Importantly, CBD products also offer a viable alternative to opioids and other medications that carry strong side effects and the potential for addiction.”
On a page entitled “What is CBD Oil?” on www.newleafpharma.com:
“Julie is a regular CBD oil user we spoke to. She said, ‘CBD oil has helped me with chronic pain that developed after I had brain and spinal surgery. It eased my nerve and muscle pain and never left me with the feeling of being drugged.”
“Jackson, a young adult who tried CBD oil as a treatment for his ADHD, also noticed the benefits.”
“Currently, CBD oil is also being studied as a treatment for Parkinson[’]s, schizophrenia, diabetes, and multiple sclerosis. . . . CBD oil can reduce cravings and anxiety in individuals with a history of heroin addiction.”
On a page entitled “NEW LEAF PHARMACEUTICAL LAUNCHES REVOLUATIONARY CANNABIDIOL (CBD) NASAL SPRAY FOR NERVOUSNESS, ACHES” on at www.newleafpharma.com:
“The therapeutic possibilities of CBD have exploded in the past decade and its benefits continue to be researched by the medical community in a wide range of areas including: anxiety, cancer, pain relief, neuroprotection, anti-inflammatory, anticonvulsant, antispasmodic, and in the relief of nausea/vomiting/motion sickness.”
Consumer testimonials that you displayed on your website at www.newleafpharma.com:
“I suffer from CRPS, Complex regional pain syndrome (CRPS) is a form of chronic pain that usually affects an arm or a leg. CRPS typically develops after an injury, a surgery, a stroke or a heart attack. . . . Received a bottle of Rhinodol from my brother-in-law and it has been super super super helpful for between my doses of other medications.. [
sic
] It helps me so much with my breakthrough pain especially when its too early to take more meds!”
“I’m a brain injured patient for the past 7 years from an auto accident. I have been suffering from headaches and body pain since June 2012 which has lead to many bad days. . . . I’ve been using CBD for pain and headaches over the past year with good results. After using the rhinodol spray bottle for a few weeks I’m noticing the healing process increased. The spray is easy to use and effective with my[ ]headache and body pain relief.”
Your “RHINODOL CBD"
products
are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the FD&C 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 the FDA, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a) unless they are over-the-counter (OTC) drugs lawfully marketed under section 505G of the FD&C Act (which is not the case for these products). FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. There are no FDA-approved applications in effect for any of the above-named products.
We recognize that your product label indicates that the ingredient Capsicum Annum Fruit Extract 5x HPUS “is in the official Homeopathic Pharmacopeia of the United States.” Under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), the term “drug” includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drug products are subject to the same statutory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, misbranding, or approval.
Misbranded Drugs
Your “RHINODOL CBD" products are also misbranded within the meaning of section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in that their labeling fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended. (See 21 CFR 201.5.) The aforementioned products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. FDA-approved prescription drugs that bear their FDA-approved labeling are exempt from the requirements that they bear adequate directions for use by a layperson. However, your products are not exempt from the requirement that their labeling bear adequate directions for use, 21 CFR 201.100(c)(2) and 201.115, because no FDA-approved applications are in effect for them. The introduction or delivery for introduction into interstate commerce of misbranded drugs violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
Conclusion
We note that, as of the date of this letter, your website www.newleafpharma.com appears to be down. However, the availability of your product on numerous websites indicates that your product continues to be shipped in interstate commerce.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your marketed 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.
You should take prompt action to address the violations cited in this letter. Failure to promptly address these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to address these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete addressing these violations within fifteen working days, state the reason for the delay and the time within which you will do so.
Your response should be sent to U.S. Food and Drug Administration, Center for Drug Evaluation and Research/Office of Compliance/Office of Unapproved Drugs and Labeling Compliance by email to
FDAADVISORY@fda.hhs.gov
.
Sincerely,
/S/
Donald D. Ashley
Director
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
Content current as of:
12/22/2020
Regulated Product(s)
Drugs