WARNING LETTER
Moorish Science Temple, The Divine and National Movement of North America, Inc; #13 The Moorish American National Republic dba Moor Herbs, Inc.
MARCS-CMS 655674 —
August 01, 2023
Delivery Method:
VIA EMAIL AND UNITED PARCEL SERVICE
Product:
Drugs
Recipient:
Recipient Name
Maria S. LeMay-Bey, Owner
Recipient Title
Isaiah Orton-Bey, Owner
Moorish Science Temple, The Divine and National Movement of North America, Inc; #13 The Moorish American National Republic dba Moor Herbs, Inc.
16136 W. 7 Mile Road
Detroit
,
MI
48235
United States
Moorherbs13@gmail.com
Issuing Office:
Division of Human and Animal Food Operations East VI
United States
WARNING LETTER
CMS Case #655674
August 1, 2023
Dear Isaiah Orton-Bey and Maria LeMay-Bey:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) has conducted an inspection of your manufacturing facility at 16136 W. 7 Mile Road, Livonia, MI 48235-2903 from February 13, 2023 to March 16, 2023. Additionally, FDA reviewed your website at https://moorherbs.com in May 2023. The inspection and our review of your website revealed serious violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and FDA regulations. You can find the FD&C Act and FDA regulations through links on FDA’s home page at www.fda.gov.
At the close of the inspection, our investigator provided you with a Form FDA 483, Inspectional Observations (FDA 483). We received your response to the FDA 483 on April 3, 2023. We address your response below.
Unapproved New Drugs and Misbranded Drugs
FDA reviewed your website, https://moorherbs.com, in May 2023 and has determined that you take orders there for the products “Full Body Antibiotic” (also referred to as “Antibiotic, Full Body”), “Anti-Viral,” “Appendix Support,” “Blood Pressure” (also referred to as “Blood Pressure Normalizer”), “Brain Tune-Up,” “Cardiovascular System,” “Headache & Pain Relief,” “Healthy Mommy Healthy Baby,” “Quit Smoking,” “HyperThyroidism” (also referred to as “HyperThyroid Support”), “HypoThyroidism” (also referred to as “HypoThyroid Support”), “Mucus Release,” “Parasite Cleanse,” “ResErection Extra Strength w/Yohimbe Bark,” “Tumor Release” (also referred to as “Tumor & Cyst Support”), “Un-Vax,” “Venereal Defense,” “Womb Care Cramp Relief & Fibroid Release” (also referred to as “Womb Care: Fibroid and Tumor Release”), and “Lungs & Respiratory.” The claims on your website establish that the products are drugs under section 201(g)(1)(B) of the FD&C Act [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease.
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
“Full Body Antibiotic” (also referred to as “Antibiotic, Full Body”)
On the “Full Body Antibiotic” product webpage of your website https://moorherbs.com:
• The product name: “Full Body Antibiotic” or “AntiBiotic, Full Body”
• “Our Moor Herbs ‘High Science’ AntiBiotic Formulae targets it all! Use it to help heal respiratory and sinus infections, bronchitis, pneumonia, strep throat, colds, flues [sic], colic, seizures, cough, diabetes, urinary problems, menstrual problems, fever, liver problems, constipation, vaginal discharge, smallpox, enlarged spleen, swelling, asthma, eye cataracts, depression, digestion problems, stomach ulcers, heart trouble, infections, migraine, stroke, pain, . . . as well as urinary tract, kidney, and bladder infections.”
• “Also beneficial for women with yeast infections, trichonomosas, bacterial vaginosis, and chlamydia.”
• “It can be helpful for people with chronic fatigue, HIV, cancer, herpes, and other chronic conditions related with depressed immunity.”
“Anti-Viral”
On the “Anti-Viral” product webpage of your website https://moorherbs.com:
• The product name: “Anti-Viral”
• “Our Moor Herbs ‘HIGH SCIENCE’ Anti-Viral Formulae is a potent and effective herbal anti-viral conducive for countering all viral conditions.”
“Appendix Support”
On the “Appendix Support” product webpage of your website https://moorherbs.com:
• “Our Moor Herbs High Science Appendix Support herbal blend is formulated to address the issues that lead to appendicitis: Constipation, Inflammation, and Infection.”
“Blood Pressure” (also referred to as “Blood Pressure Normalizer”)
On the “Blood Pressure” product webpage of your website https://moorherbs.com:
• The product name: “Blood Pressure Normalizer”
• “Our Moor Herbs ‘HIGH SCIENCE’ Blood Pressure Normalizor [sic] is supported by an Indian medicinal herb belonging to Caesalpiniaceae family of plants.…What makes these seeds really popular, is their ability to lower blood pressure. Acting as a hypotensive agent, this humble seed works wonders for those looking to control their BP naturally.”
• “It is a strong anti bacterial agent...”
“Brain Tune-Up”
On the “Brain Tune-Up” product webpage of your website https://moorherbs.com:
• “The 2 main ingredients in this blend are Gotu Kola and Ginko Biloba[.] Gotu Kola Leaf… is anti-inflammatory, antiviral, antibacterial, . . . and antifungal. In human studies, gotu kola . . . reduced symptoms of anxiety and depression. It has been used to treat brain-related disorders including mental fatigue, anxiety, depression, memory loss, and insomnia.”
• “Protects the brain from damage”
• “Alleviates stress, anxiety, and depression”
• “Improves memory and mood in Alzheimer’s patients”
• “Ginko Biloba has been repeatedly evaluated for its ability to reduce anxiety, stress and other symptoms associated with Alzheimer’s disease …”
• “Can Help Fight Inflammation.”
• “Reduces Symptoms of Psychiatric Disorders and Dementia.”
• “Can Reduce Anxiety.”
• “Can Treat Depression.”
“Cardiovascular System”
On the “Cardiovascular System” product webpage of your website https://moorherbs.com:
• “This ‘High Science’ Formula is designed to rebuild a degenerative heart...”
“Headache & Pain Relief”
On the “Headache & Pain Relief” product webpage of your website https://moorherbs.com:
• The product name: “Headache & Pain Relief”
• “Our Headache and Pain formula is a natural anodyne concoction that contains plants naturally rich in salicin that naturally breaks down into salicylic acid in the body that is anti-inflammatory in nature and thus effective where there is pain, which is a sensor that something is wrong on a deeper level.”
“Healthy Mommy Healthy Baby”
On the “Healthy Mommy Healthy Baby” product webpage of your website https://moorherbs.com:
• “Note: This blend is also helpful for the following conditions: anemia, low blood, arthritis, asthma, hay fever, sinusitis, gout, emphysema, bronchitis, sinus relief, allergies, high blood pressure, nosebleeds, hemorrhaging, miscarriage (vitamin K), hardened arteries, tooth decay, peptic ulcers, duodenum ulcers, infections, drug and chemical toxins, skin problems, edema, water retention, bowels, gas pains...”
“Quit Smoking”
On the “Quit Smoking” product webpage of your website https://moorherbs.com:
• The product name: “Quit Smoking”
• “Our Moor Herbs ‘High Science’ Quit Smoking Formulae is a herbal compound of Nature’s best herbs that have been utilized traditionally to help purify the bloodstream of pollutants and toxins, cleanse the liver…and develop a distaste of insidious addictive man- chemicals.”
“HyperThyroidism” (also referred to as “HyperThyroid Support”)
On the “HyperThyroidism” product webpage of your website https://moorherbs.com:
• The product name: “HyperThyroidism” or “HyperThyroid Support”
• “For an overactive Thyroid”
• “Moor Herbs High Science HyperThyroidism Relief Formulae is designed for an over-active thyroid gland. Effective for calming down an overactive thyroid and reducing symptoms of hyperthyroidism such as agitation, restlessness, sweating and insomnia.”
“HypoThyroidism” (also referred to as “HypoThyroid Support”)
On the “HypoThyroidism” product webpage of your website https://moorherbs.com:
• The product name: “HypoThyroidism” or “HypoThyroid Support”
• “For an underactive Thyroid”
• “Moor Herbs High Science Thyroid Support Formula consists of Nature’s plants high in organic iodine and which perform a myriad of beneficial functions for the thyroid gland including…normalizing the function of metabolism. An impaired thyroid gland can lead to a host of negative health problems so good thyroid health is imperative for overall good health.”
“Mucus Release”
On the “Mucus Release” product webpage of your website https://moorherbs.com:
• “Mucus Release is a powerful ‘High Science’ formula that consists of effective expectorant herbs that help dissolve hardened, stubborn mucus and phlegm that obstruct the mucous membranes and lead to pathology throughout the body…Mucus Release is great for all mucus conditions!”
“Parasite Cleanse”
On the “Parasite Cleanse” product webpage of your website https://moorherbs.com:
• The product name: “Parasite Cleanse”
• “Parasite Cleanse ‘High Science’ Formula contain[s] some of Nature’s best anthelmintic herbs that have been traditionally used for centuries by various cultures to remove parasites and worms from the tissues of the body. These creepy critters most certainly rob the body of nutrients and impair critical functions of the organs, glands, and systems of the body.”
“ResErection Extra Strength w/ Yohimbe Bark”
On the “ResErection Extra Strength w/ Yohimbe Bark” product webpage of your website https://moorherbs.com:
• “Our Moor Herbs ‘High Science’ Resurrection formulae, is a 100% all-natural herbal-based formula for men experiencing difficulty with attaining and maintaining an erection (penile erectile dysfunction) with the root cause being poor circulation due to poor diet (and lifestyle) – a diet too high in animal protein (meat, flesh, cadavaer, carion, etc.) and animal fat which clogs the veins and arteries and thus impairing circulation which is vital for a healthy, solid, firm, and stiff erection.”
“Tumor Release” (also referred to as “Tumor & Cyst Support”)
On the “Tumor Release” product webpage of your website https://moorherbs.com:
• The product name: “Tumor Release” or “Tumor & Cyst Support”
• “Our Moor Herbs ‘High Science’ Tumor Release Formulae is a safe, sane and effective plant-based anti-neoplastic formulae that is helpful in natural, noninvasive, benign and malignant tumor dissolution.”
• “The formula is useful for all tumor and cyst formations in the body, including uterine and ovarian cysts/tumors. Good for both internal and external tumors.”
“Un-Vax”
On the “Un-Vax” product webpage of your website https://moorherbs.com:
• “Our Moor Herbs ‘HIGH SCIENCE’ Herbal UN-VAX Formulae is an unique formula designed to remove heavy metal toxins from the body. It is an ideal Formulae to combat mercury (ethyl and methyl) toxicity and aluminum toxicity, both of which are known to cause a plethora of adverse health conditions, especially in children.”
“Venereal Defense”
On the “Venereal Defense” product webpage of your website https://moorherbs.com:
• The product name: “Venereal Defense”
• “Our Moor Herbs High Science Venereal Defense Formulae helps foment natural healing of adverse conditions that are passed on from one person to another through intimate contact.”
“Womb Care Cramp Relief & Fibroid Release” (also referred to as “Womb Care: Fibroid and Tumor Release”)
On the “Womb Care Cramp Relief & Fibroid Release” product webpage of your website https://moorherbs.com:
• The product name: “Womb Care Cramp Relief & Fibroid Release” or “Womb Care: Fibroid and Tumor Release”
• “Our Moor Herbs ‘High Science’ Fibroid/Tumor Release Formulae is an all-natural herbal formulation consisting of Nature’s herbs that have an affinity for the female uterus, e.g. Chaste berry and Dong Quai and that are also anti-neoplastic (anti-tumor growth and formation) in nature, e.g. Burdock and Comfrey, thus combating tumorous growth on the uterus, e.g. fibroid tumors or uterine fibroids, facilitating dissolution via the vaginal canal and other eliminative channels.”
• “Fibroids/Tumor Release, is a product that can be used in an overall regimen to help females naturally dissolve tumors of the reproductive system and is a great post Womb Cleanse formulae to consume daily.”
• “Recommended for: Uterine fibroids or fibroid tumors, cervical tumors, uterine cysts.”
“Lungs & Respiratory”
On the “Lungs & Respiratory” product webpage of your website https://moorherbs.com:
• “This High Science Formula is a highly effective anti-tussive and expectorant science formulae.”
Your 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)].
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 FD&C 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 FD&C 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 FD&C 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 “Full Body Antibiotic” (also referred to as “Antibiotic, Full Body”), “Anti-Viral,” “Blood Pressure” (also referred to as “Blood Pressure Normalizer”), “Brain Tune-Up,” “Healthy Mommy Healthy Baby,” “HyperThyroidism” (also referred to as “HyperThyroid Support”), “HypoThroidism” (also referred to as “HypoThyroid Support”), “ResErection Extra Strength w/Yohimbe Bark,” “Tumor Release” (also referred to as “Tumor & Cyst Support”), “Venereal Defense,” and “Womb Care Cramp Relief & Fibroid Release” (also referred to as “Womb Care: Fibroid and Tumor Release”) products 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 these products safely for their intended purposes. Accordingly, your “Full Body Antibiotic” (also referred to as “Antibiotic, Full Body”), “Anti-Viral,” “Blood Pressure” (also referred to as “Blood Pressure Normalizer”), “Brain Tune-Up,” “Healthy Mommy Healthy Baby,” “HyperThyroidism” (also referred to as “HyperThyroid Support”), “HypoThroidism” (also referred to as “HypoThyroid Support”), “ResErection Extra Strength w/Yohimbe Bark,” “Tumor Release” (also referred to as “Tumor & Cyst Support”), “Venereal Defense,” and “Womb Care Cramp Relief & Fibroid Release” (also referred to as “Womb Care: Fibroid and Tumor Release”) products fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the FD&C 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 FD&C Act [21 U.S.C. 331(a)].
Adulterated Dietary Supplements
The dietary supplements manufactured at your facility are adulterated under section 402(g)(1) of the FD&C Act [21 U.S.C. 342(g)(1)] because they have been prepared, packed, or held under conditions that do not meet the Current Good Manufacturing Practice (CGMP) regulation for dietary supplements (21 CFR Part 111). During the inspection of your facility, FDA investigators observed the following significant violations of the CGMP regulation for dietary supplements:
1. You failed to establish the specifications required under 21 CFR 111.70. Specifically:
a. You failed to establish the following required component specifications under 21 CFR 111.70(b) for each component that you use in the manufacture of a dietary supplement: (1) identity specifications, as required by 21 CFR 111.70(b)(1); and (2) component specifications that are necessary to ensure that specifications for the purity, strength, and composition of the dietary supplements manufactured using the components are met, as required by 21 CFR 111.70(b)(2). Specifically, when our investigators requested such component specifications for the Coltsfoot, Wild Cherry Bark, and Boneset Herb ingredients used in the manufacturing of your “Lungs & Respiratory” finished dietary supplement product, you were unable to provide such component specifications. We have reviewed your written response on April 3, 2023, in which you state that you “are in the process of establishing component specifications for identity, purity, strength and composition of the finished dietary supplement.” We cannot evaluate the adequacy of your corrective action, because you did not provide any additional evidence or supporting documentation for review.
b. You failed to establish specifications for dietary supplement labels (labeling specifications), as required by 21 CFR 111.70(d). Specifically, you were unable to provide labeling specifications for your “Anti-Viral,” “Full Body Antibiotic” (also referred to as “Antibiotic, Full Body”), and “Lungs & Respiratory” finished dietary supplement products when requested by our investigators. We have reviewed your written response on April 3, 2023, in which you state that you are in the process of establishing written labeling specifications. We cannot evaluate the adequacy of your corrective action, because you did not provide any additional evidence or supporting documentation for review.
c. You failed to establish specifications for each dietary supplement that you manufacture for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e). Specifically, you were unable to provide finished product specifications for your “Anti-Viral,” “Full Body Antibiotic” (also referred to as “Antibiotic, Full Body”), and “Lungs & Respiratory” finished dietary supplement products when requested by our investigators. We have reviewed your written response on April 3, 2023, in which you state that you “are in the process of establishing product specifications for identity, purity, strength and composition of the finished dietary supplement.” We cannot evaluate the adequacy of your corrective action, because you did not provide any additional evidence or supporting documentation for review.
We note that once you have established these specifications, you must determine whether the specifications that you establish under 21 CFR 111.70 are met, as required by 21 CFR 111.73 and 21 CFR 111.75(c). Specifically, once you have established component specifications and before using a component, you must conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, as required by 21 CFR 111.75(a)(1)(i), unless you petition the agency under 21 CFR 111.75(a)(1)(ii) and the agency exempts you from such testing. You must also confirm the identity of other components and determine whether other applicable component specifications established in accordance with 21 CFR 111.70(b) are met, as required by 21 CFR 111.75(a)(2). Further, you must verify that your finished batch of the dietary supplement meets product specifications for the identity, purity, strength, composition, and for limits on those types of contamination that may adulterate or that lead to adulteration of the finished batch of the dietary supplement, as required by 21 CFR 111.75(c).
You must also make and keep records, including records for the specifications you establish, in accordance with 21 CFR 111.95.
2. You failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103, and make and keep records of such procedures, as required by 21 CFR 111.140(b)(1). Specifically, you told our investigators that you have no written procedures for quality control operations and that you do not have a quality control program in place.
We have reviewed your written response received on April 3, 2023, in which you state that you “are in the process of implementing quality control operations to ensure the quality of dietary supplements” and “are also in the process of establishing written procedures and training quality control personnel to ensure all is produced safely, accurately, and according to the standards we have, and are putting, in place.” We cannot evaluate the adequacy of your corrective action, because you did not provide any additional evidence or supporting documentation for review.
3. You did not prepare and follow a master manufacturing record (MMR) for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205(a). Upon request, you could not provide written MMRs for your “Anti-Viral,” “Full Body Antibiotic” (also referred to as “Antibiotic, Full Body”), and “Lungs & Respiratory” finished dietary supplement products to our investigators. You stated that you did not have these records, and none were provided.
We have reviewed your written response received on April 3, 2023, in which you state that you “are in the process of establishing Master Manufacturing Records for each dietary supplement and size.” We cannot evaluate the adequacy of your corrective action, because you did not provide any additional evidence or supporting documentation for review.
4. Your batch production record did not include complete information relating to the production and control of each batch, as required under 21 CFR 111.255(b) and 21 CFR 111.260. Specifically, batch production records for “Anti-Viral” manufactured on
(b)(4)
with lot #
(b)(4)
, “Full Body Antibiotic” (also referred to as “Antibiotic, Full Body”) manufactured on
(b)(4)
with lot #
(b)(4)
, and “Lungs & Respiratory” manufactured on
(b)(4)
with lot #
(b)(4)
, were collected and reviewed. These records do not include complete information required to be in batch production records. The required information that your records are missing includes, but is not limited to, the following:
• The identity of equipment and processing lines used in producing the batch [21 CFR 111.260(b)];
• The date and time of the maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch, or a cross-reference to records where this information is retained [21 CFR 111.260(c)]; The unique identifier that you assigned to each component, packaging, and label used [21 CFR 111.260(d)];
• A statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing [21 CFR 111.260(f)];
• The actual results obtained during any monitoring operation [21 CFR 111.260(g)];
• The results of any testing or examination performed during the batch production, or a cross-reference to such results [21 CFR 111.260(h)];
• Documentation at the time of performance of the manufacture of the batch, including [21 CFR 111.260(j)]:
o The date on which each step of the MMR was performed [21 CFR 111.260(j)(1)]; and
o The initials of the persons performing each step [21 CFR 111.260(j)(2)], including:
 The initials of the person responsible for weighing or measuring each component used in the batch;
 The initials of the person responsible for verifying the weight or measure of each component used in the batch;
 The initials of the person responsible for adding the component to the batch; and
 The initials of the person responsible for verifying the addition of components to the batch;
• Documentation at the time of performance of packaging and labeling operations [21 CFR 111.260(k)], including:
o The unique identifier that you assigned to packaging and labels used, the quantity of the packaging and labels used, and, when label reconciliation is required, reconciliation of any discrepancies between issuance and use of labels [21 CFR 111.260(k)(1)];
o An actual or representative label, or a cross-reference to the physical location of the actual or representative label specified in the MMR [21 CFR 111.260(k)(2)]; and
o The results of any tests or examinations conducted on packaged and labeled dietary supplements (including repackaged or relabeled dietary supplements), or a cross-reference to the physical location of such results [21 CFR 111.260(k)(3)];
• Documentation at the time of performance that quality control personnel [21 CFR 111.260(l):
o Reviewed the batch production record [21 CFR 111.260(l)(1), including:
 Review of any monitoring operation required under subpart E of 21 CFR part 111 [21 CFR 111.260(l)(i)]; and
 Review of the results of any tests and examinations, including tests and examinations conducted on components, in-process materials, finished batches of dietary supplements, and packaged and labeled dietary supplements [21 CFR 111.260(l)(ii)];
o Approved or rejected any reprocessing or repackaging [21 CFR 111.260(l)(2)]; and
o Approved and released, or rejected, the batch for distribution, including any reprocessed batch [21 CFR 111.260(l)(3)]; and
o Approved and released, or rejected, the packaged and labeled dietary supplement, including any repackaged or relabeled dietary supplement [21 CFR 111.260(l)(4)].
• Documentation at the time of performance of any required material review and disposition decision [21 CFR 111.260(m)];
• Documentation at the time of performance of any reprocessing [21 CFR 111.260(n)].
We have reviewed your written response received on April 3, 2023, in which you state that you “are still in the process of establishing and implementing the systems (as discussed throughout this document and the investigators observations) that will allow us to produce complete batch records.” We cannot evaluate the adequacy of your corrective action, because you did not provide any additional evidence or supporting documentation for review.
5. You failed to establish and follow written procedures for the requirements to review and investigate a product complaint, as required under 21 CFR 111.553. Specifically, our investigators requested your written procedures to review and investigate a product complaint. You stated that you did not have this procedure, and you did not provide it.
We have reviewed your April 3, 2023, written response, in which you state, “We’ve been operating since March of 2015 and have never received a complaint. However, we are in the process of establishing written procedures for reviewing and investigating product/customer complaints.” We cannot evaluate the adequacy of your corrective action, because you did not provide any additional evidence or supporting documentation for review.
6. You failed to establish and follow written procedures for when a returned dietary supplement is received, as required under 21 CFR 111.503. Specifically, our investigators requested your written procedures for when a returned dietary supplement is received. You stated that you did not have these written procedures, and none were provided.
We have reviewed your April 3, 2023, written response, in which you state that you “are in the process of establishing written procedures for when a returned dietary supplement is received.” We cannot evaluate the adequacy of your corrective action, because you did not provide any additional evidence or supporting documentation for review.
7. You failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. Specifically, during the inspection, you said you had not established written procedures for holding and distributing operations.
Once have you established written procedures for your holding and distributing operations, you must make and keep records of such written procedures, as required by 21 CFR 111.475(b)(1).
We have reviewed your April 3, 2023, written response, in which you state that you “are in the process of establishing written procedures for holding and distributing operations.” We cannot evaluate the adequacy of your corrective action, because you did not provide any additional evidence or supporting documentation for review.
8. You did not maintain and clean equipment, utensils, and contact surfaces used to manufacture, package, label, or hold components or dietary supplements, as required under 21 CFR 111.27(d). P
Specifically, on
(b)(4)
, during the manufacturing of your “Lungs & Respiratory” finished dietary supplement product, your multi-functional grinder was observed with a light green and brown residue inside the bowl and the
(b)(4)
plastic capsule filling equipment was observed with a light brown powder and brown staining. Furthermore, the method you used for cleaning and sanitizing your utensils and equipment does not align with, and directly contradicts, the manufacturer’s written instructions on the cleaning and sanitizing products. Additionally, you do not have any written procedures for cleaning or sanitizing your utensils and equipment, as required under 21 CFR 111.25(c).
We have reviewed your April 3, 2023, written response, in which you state that you “have since corrected the way we wash and sanitize our utensils and equipment, according to the instructions indicated on the cleaning agents we use, combined with regulations outlined under Michigan Food Law.” These corrections will be evaluated during the next FDA inspection of your firm. You also stated in your response that you “are in the process of establishing written procedures for cleaning and sanitizing utensils and equipment.” We cannot evaluate the adequacy of your corrective action, because you did not provide any additional evidence or supporting documentation for review.
Misbranded Dietary Supplements
In addition, your “Lungs and Respiratory,”
“Full Body Antibiotic” (also referred to as “Antibiotic, Full Body”)
, “Antiviral,” “Blood Pressure” (also referred to as “Blood Pressure Normalizer”),, “Headache & Pain Relief,” and “Bright Eyes” products are misbranded dietary supplements under Section 403 of the Act [21 U.S.C. § 343] because they do not comply with the labeling requirements for dietary supplements as required by 21 CFR 101 as follows:
1. Your “Lungs and Respiratory,”
“Full Body Antibiotic” (also referred to as “Antibiotic, Full Body”)
, “Antiviral,” “Blood Pressure” (also referred to as “Blood Pressure Normalizer”), “Headache & Pain Relief,” and “Bright Eyes” products are misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving size declared on the labels is are incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Your Lungs and Respiratory, Full Body Antibiotic, Antiviral, Blood Pressure Normalizer, Headache & Pain Relief, and Bright Eyes product labels’ serving sizes is declared as “3 Capsules or 3 Scoops” and are not specific to each product.
2. Your “Lungs and Respiratory,”
“Full Body Antibiotic” (also referred to as “Antibiotic, Full Body”)
, “Antiviral,” “Blood Pressure” (also referred to as “Blood Pressure Normalizer”), “Headache & Pain Relief,” and “Bright Eyes” products are misbranded within the meaning of sections 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the presentation of nutrition information on the labeling of the products does not comply with 21 CFR 101.36. Specifically,
• The title “Supplement Facts” is not set at full width of the nutrition label, in accordance with 21 CFR 101.36(e)(1).
• The dietary ingredients are not indented under the title “Proprietary Herbal Blend”, in accordance with 21 CFR 101.36(c)(2).
• The quantitative amount by weight per serving of proprietary blend does not use metric measures in appropriate units (i.e., 1000 units must be declared in the next higher set of units, e.g., 10000 mg must be expressed as 10 g), in accordance with 21 CFR 101.36(b)(3)(ii)(A).
3. Your Lungs and Respiratory,”
“Full Body Antibiotic” (also referred to as “Antibiotic, Full Body”)
,, “Headache & Pain Relief," and “Blood Pressure” (also referred to as “Blood Pressure Normalizer”) products are misbranded within the meaning of section 403(s)(2)(C) of the Act [U.S.C. § 343(s)(2)(C)] in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1) and 101.36(d)(1). If the whole or entire part is used, this must be declared.
4. Your “Blood Pressure” (also referred to as “Blood Pressure Normalizer”) and “Headache & Pain Relief” products are misbranded within the meaning of section 403(i)(2) of the Act in that the labels fail to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). For example:
• The Blood Pressure Normalizer product label lists “manjishtha”, but this is not the standardized common name of the dietary ingredient. The label must list the standardized common name (SCN) given in the reference Herbs of Commerce, “Indian madder”. The Ayurvedic name for Indian madder (manjishtha) may follow the SCN in parentheses.
• The SCN for the term “Chaksu” must be declared; in the absence of a SCN, the Latin binomial name must be declared.
• The Headache & Pain Relief product declares “dashmoola”. The dietary ingredient(s) that make up the “dashmoola” must be declared by the SCN; in the absence of a SCN, the Latin binomial name for the dietary ingredient must be declared.
5. Your “Lungs and Respiratory,”
“Full Body Antibiotic” (also referred to as “Antibiotic, Full Body”)
, “Antiviral,” “Blood Pressure” (also referred to as “Blood Pressure Normalizer”), “Headache & Pain Relief,” and “Bright Eyes” products are misbranded within the meaning of section 403(i)(2) [21 U.S.C. § 343(i)(2)] of the Act because the labels fail to declare all ingredients, as required by 21 CFR 101.4. Specifically, the products fail to declare the ingredients of the capsule material.
Conclusion
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 FD&C Act, include your reasoning and any supporting information for our consideration.
We offer the following additional comments:
1. Your “Lungs and Respiratory,”
“Full Body Antibiotic” (also referred to as “Antibiotic, Full Body”)
, “Antiviral,” “Blood Pressure” (also referred to as “Blood Pressure Normalizer”), “Headache & Pain Relief,” and “Bright Eyes” product labels do not bear a symbol next to the structure/function claim linking the claim to the disclaimer. Furthermore, the disclaimer fails to be enclosed in a box, in accordance with 21 CFR 101.93(d).
Your response should be sent to the U.S. Food and Drug Administration; Attn: Katie Cutajar, Compliance Officer, via email at ORAHAFEAST6FirmResponses@fda.hhs.gov, or at 300 River Place Suite 5900, Detroit, MI 48207. If you have questions regarding this letter, please contact CO Cutajar at (313) 680-6962 or via email at Kathryn.Cutajar@fda.hhs.gov.
Sincerely,
/S/
William R. Weissinger, MS
Program Division Director
Office of Human and Animal Food Operations
East Division 6
Content current as of:
09/19/2023
Regulated Product(s)
Drugs