WARNING LETTER
G & L Wellness, LLC
MARCS-CMS 609572 —
December 22, 2020
Product:
Animal & Veterinary
Drugs
Recipient:
Recipient Name
Lois Carter
Recipient Title
President
G & L Wellness, LLC
2231 14th St S 114
Wisconsin Rapids
,
WI
54494
United States
content@glwellness.net
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
WARNING LETTER
December 21, 2020
RE: 609572
Dear Ms. Carter:
This letter is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address www.glwellness.net in August and December 2020 and
has determined that you
take orders
there
[1]
for
the “C BETTER DAILY Adult Regular Formula,” “C BETTER DAILY Adult Maximum Formula,” and “C BETTER DAILY Soothing Formula,” (hereinafter collectively referred to as “your C BETTER DAILY products for humans”) all of which you promote as eye drop products containing cannabidiol (CBD) for human use.
The claims on your website establish
that
your C BETTER DAILY products for humans
are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 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). FDA has also determined that you take orders for the product “C BETTER DAILY Pet Formula” on your website at www.glwellness.net. This product, which you promote as an eye drop product containing CBD, is an unapproved new animal drug that is unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5).
These products are especially concerning from a public health perspective because ophthalmic drug products can pose serious risk of harm to humans and/or animals if toxic substances are introduced directly into the eye because irreversible damage, including vision loss, can result.
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 websites, your C BETTER DAILY products for humans 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 website www.glwellness.net and/or label of your products that establish their intended uses as drugs include, but may not be limited to, the following:
On your
product label
for “C BETTER DAILY Adult Maximum Formula”:
"MULTI SYMPTOM EYE CARE”
On your product webpage for “C BETTER DAILY” at your website www.glwellness.net, you state:
Under a
rotating banner titled
“C BETTER DAILY”:
“C Better Daily is the hemp industries first and only multi-symptom eye care solution.”
“A harmonic blend of herbal extracts chosen for their ability to reduce swelling, itching and inflammation.”
“Antioxidant”
“Anti-Inflammatory”
Under
“Intended for Daily Use”:
“Organic chamomile hydrosol is the base of all our formulas, chosen for its long-standing history of traditional use as an anti-inflammatory, antioxidant and mild astringent.”
Under “Research”:
“G & L Wellness had introduced the world’s first and only hemp derived multi symptom eye care solution for both people and pets and they quickly started to make their way across the country and the world!”
“Applications of CBD as an anti-inflammatory, anti-bacterial, neuroprotective and vasodilator compound are well researched and documented.”
“Both minor and major eye related issues are beginning to be clinically researched as to what role the ECS [endocannabinoid system] and the receptors, enzymes and endocannabinoids within play to the overall health and longevity of our eyes.”
“N-Acetylcysteine (NAC) is present in three of our formulas, Maximum, Regular and Pet in various concentrations. It is a powerful antioxidant. Among ocular research, you will discover that this amino acid is reviewed throughout clinical studies for its effect on cataracts, macular degeneration, dry eye, facilitation of wound healing in damaged corneal epithelial cells and other degenerative eye diseases . . .
It is often used as a dietary supplement or as an ingredient incorporated into medications, for example, as an inhalant used by pulmonary specialists in the treatment of cystic fibrosis.”
Your
C BETTER DAILY products for humans
are
not generally recognized as safe and effective for their 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-mentioned products.
Misbranded Drugs
Your C BETTER DAILY products for humans 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, under 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 these misbranded drugs violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
Unapproved New Animal Drugs
During our review of your firm’s website www.glwellness.net, FDA determined that your firm is marketing the unapproved new animal drug “C BETTER DAILY Pet Formula.” Based on our review of your website, your “C BETTER DAILY Pet Formula” product is a drug under section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals. Further, as discussed below, this product is an unapproved new animal drug and marketing it violates the FD&C Act.
Examples of claims observed on your website www.glwellness.net that establish the intended uses of this product include, but may not be limited to, the following:
On your product webpage for “C BETTER DAILY Pet Formula” at your website www.glwellness.net, you state:
Under a rotating banner titled “C BETTER DAILY Pet Formula”:
“A harmonic blend of herbal extracts chosen for their ability to reduce swelling, itching and inflammation.”
Under “Research”:
“[T]he world’s first and only hemp derived multi symptom eye care solution for both people and pets…”
“Applications of CBD as an anti-inflammatory, anti-bacterial, neuroprotective and vasodilator compound are well researched and documented.”
Under “Consumer Commonly Asked Questions”:
“Ingredients in C Better Daily may reduce pain, inflammation and redness…”
Your “C BETTER DAILY Pet Formula” product is a “new animal drug,” as defined by section 201(v) of the FD&C Act, 21 U.S.C. 321(v), because it is not generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. To be legally marketed, a new animal drug must have an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act, 21 U.S.C. 360b, 360ccc, and 360ccc-l. Your “C BETTER DAILY Pet Formula”  product is not approved, conditionally approved, or index listed by the FDA, and therefore this product is considered unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5). Introduction of this adulterated drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
Conclusion
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 violations may result in legal action without further notice, including, without limitation, seizure and/or 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, 10903 New Hampshire Avenue, WO51, Silver Spring, MD 20993-0002 or by e-mail to
FDAADVISORY@fda.hhs.gov
.
Sincerely,
/S/
Donald D. Ashley
Director
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
/S/
Eric Nelson
Director of Compliance
Office of Surveillance & Compliance
Center for Veterinary Medicine
Food and Drug Administration
[1]
In addition to taking orders from your website at www.glwellness.net, we also observed that you direct consumers to the website www.proteambrady.com to purchase your products. By directing consumers to www.proteambrady.com to purchase your products, your firm is responsible for causing the introduction or delivery into interstate commerce of products that are unapproved new drugs and misbranded under section 505(a) of the FD&C Act and/or misbranded under 502 of the FD&C Act, which is prohibited under sections 301(a), (d), and (k) of the FD&C Act, 21 U.S.C. 331(a), (d), and (k).
Content current as of:
12/22/2020
Regulated Product(s)
Animal & Veterinary
Drugs