WARNING LETTER
Herbal Healer Academy, Inc. MARCS-CMS 570957 —
- Delivery Method:
- UPS Overnight
- Product:
- Drugs
- Recipient:
-
Recipient NameMisty D. Huff
- Herbal Healer Academy, Inc.
127 McCain Drive
Mountain View, AR 72560
United States
- Issuing Office:
- Division of Human and Animal Food Operations West III
4040 North Central Expressway, Suite 300
Dallas, TX 75204-3128
United States
September 12, 2019
CMS # 570957
WARNING LETTER
Dear Mrs. Huff,
The United States Food and Drug Administration (FDA) conducted an inspection of your facility, located at 127 McCain Drive, Mountain View, Arkansas on November 5 through November 9, 2018. During the inspection, we collected your product labels and product catalog entitled “Herbal Healer Academy Inc. Natural Medicine Supply Catalog.” Based on the inspectional findings, a subsequent review of the product labels and product catalog collected during the inspection, and a subsequent review of your website at the Internet address www.herbalhealer.com, we have identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations.
You can find the Act and FDA regulations through links on the FDA’s home page at http://www.fda.gov.
Unapproved New Drugs and Misbranded Drugs
FDA reviewed your website at the Internet address www.herbalhealer.com in June 2019 and has determined that you take orders there for the products HHA CMO (Cetyl Myristoleate), HHA Colloidal Silver, HHA 4-Herb Tea Bulk, HHA 4-Herb Concentrate, Apricot Kernels, HHA Olive Leaf Liquid, HHA 5-HTP, HHA Herbalgesic, HHA CoQ10 with Hawthorn Berry, HHA Glucosamine & Chondroitin, Angiostop, HHA Beta Glucans, HHA Prostate Support and The Healing Formula Wound Care. In addition, FDA reviewed your product catalog following an inspection of your facility at 127 McCain Drive, Mountain View, Arkansas on November 5 through November 9, 2018. The claims on your website and within your product catalog establish that the HHA CMO (Cetyl Myristoleate), HHA Colloidal Silver, HHA 4-Herb Tea Bulk, HHA 4-Herb Concentrate, Apricot Kernels, HHA Olive Leaf Liquid, HHA 5-HTP, HHA Herbalgesic, HHA CoQ10 with Hawthorn Berry, HHA Glucosamine & Chondroitin, Angiostop, HHA Beta Glucans, HHA Prostate Support, The Healing Formula Wound Care, HHA Colloidal Minerals, HHA Marine Sea Cucumber, HHA U.T. Clear, HHA Flew Away, HHA Olive Leaf Extract, and HHA 4-Herb Tea products are drugs under section 201(g)(1)(B) of 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.
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
HHA CMO (Cetyl Myristoleate)
On the webpage https://www.herbalhealer.com/cmo/:
? “Many people have reported relief from crippling arthritis in just 30 days using this product…”
HHA Colloidal Silver
On the webpage https://www.herbalhealer.com/products/colloidal-silver/:
? “Colloidal Silver has successfully controlled: … blood parasites, boils, candida, chronic fatigue syndrome (CFS), colitis, herpes, lupus, malaria, viral and fungal infections, rheumatoid arthritis, ringworm, shingles, yeast infections…”
HHA 4-Herb Tea Bulk:
The product web page for 4-Herb Tea Bulk at https://www.herbalhealer.com/4-herb-teabulk/ after clicking on the phrase “Click here for more information on the 4-Herb Tea!” directs to a document entitled “EssiacTM & HHA 4-Herb Tea Information” on the webpage https://www.herbalhealer.com/content/4herb/4herbinfo.pdf which makes the following statements concerning the product:
? “The herbal formula developed by Rene Cuisse back in the 20's is a simple, effective herbal remedy for many ailments. The formula is made up of 4 herbs that are primary… Demulcent (sooths irritations and inflammations). The main ingredient, Burdock Root is known to specifically helps neutralize toxins in the blood.”
? “Do not substitute the concentrate formula for the original brew at home herbs when using it for cancer.”
HHA 4-Herb Concentrate
On the webpage https://www.herbalhealer.com/4-herb-concentrate/:
? “[H]elp depression…”
Apricot Kernels
On the webpage https://www.herbalhealer.com/apricot-kernels-8-oz-new-pricing/:
? “CANCER SUPPLEMENTS…Natural Laetrile…”
HHA Olive Leaf Liquid
On the webpage https://www.herbalhealer.com/olive-leaf-liquid/:
? “Natural anti-viral - many cancers are triggered by viral infection…”
? “FDA will not allow us to say this can be used as an antiviral supplement, however, extensive research in Israel has proven it is effective and should be supplemented with viral illness...”
HHA 5-HTP
On the webpage https://www.herbalhealer.com/5-htp/:
? “Use to help sleep disorders, depression and obesity.”
HHA Herbalgesic
On the webpage https://www.herbalhealer.com/herbalgesic/:
? “This herbal analgesic has been formulated to assist with aches, pains and inflammation. It may produce a calming sedative effect while decreasing the body's perception of intense pain. Often used as an effective herbal alternative to over the counter pain relievers.”
HHA CoQ10 with Hawthorn Berry
On the webpage https://www.herbalhealer.com/coq10-with-hawthorn-berry/:
? “COQ10 has been a helpful and safe supplement with Heart failure, Cardiomyopathy, Heart Attack Prevention and Recovery…Gum Disease, Parkinson's disease... This is an exceptional supplement for all heart and arterial problems & cancer…”
HHA Glucosamine & Chondroitin
On the webpage https://www.herbalhealer.com/glucosamine-chondroitin-120-cap/:
? “Helps prevent and repair damaged joints and cartilage. Relieves pain in treatment of osteoarthritis and rheumatic disorders.”
Angiostop
On the webpage https://www.herbalhealer.com/angiostop/:
? “Angiostop is … designed to curb excessive Angiogenesis. Inhibits excessive blood vessel formation, promotes effective immune response to maintain healthy cellular growth and improves phagocytic activity. Natural support for neoangiogenesis/RTK inhibition.”
HHA Beta Glucans
On the webpage https://www.herbalhealer.com/beta-glucans/:
? “Here is what a leading research scientist, Dr. Jan Rae, from Norway has to say. ‘Beta 1,3/1,6 Glucans is truly a miracle of nature. It rapidly activates the immune system safely and naturally. Activation begins with your macrophage cells, one of the most important parts of your immune system, and it's first defense against viral, fungal, bacterial and parasitic infections. Besides most pathogens, macrophages can recognize most tumor cells. In fact any cancer is fair game for an activated macrophage!’ Once the macrophages are activated the body calls up the rest of the immune system response as well. Activating your macrophage cells results in a total immune response, assaulting invaders in full force until they are defeated.”
? “If you have any of the following ailments you should supplement HHA Beta Glucans right away: Cancer, Allergies, Herpes, Bacterial Infections, Fungal Infections, Viral Infection, HIV, Bronchitis, Mononucleosis, Candidiasis, Parasites, Periodontal Disease, Chronic Unknown Infection, Pneumonia, CFS, Emphysema, CMV Virus, Aging Flu, Colds, Radiation Damage, Diabetes, Environmental Illness, Epstein Barr Virus, Arthritis, Heart Disease, Recovering from Surgery, Recovering from any other medical procedure.”
? “HELPS RADIATION DAMAGE This was an extremely important finding. The damage to the immune system that is received from radiation therapies as well as chemotherapies can be safely helped with Beta Glucans. Not only that, we have a great deal of increased radiation toxicity on the planet due to nuclear detonations, solar flares, depleted ozone, etc., that is weakening healthy immune systems. Just two caps a day will help your body combat this.”
HHA Prostate Support
On the webpage https://www.herbalhealer.com/prostate-support/:
? “Use this for all male reproductive disorders. We have had exceptional results with this product for enlarged prostate and all prostate disorders when used with the 4-Herb tea.”
The Healing Formula Wound Care
On the webpage https://www.herbalhealer.com/wound-care/:
? “This formula has proven very effective in other skin wounds such as diabetic ulcers, MRSA, cuts, abrasions, rashes and burns. The formula works by oxygenating the area, stopping infection, reducing pain while promoting healing.”
Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of Liquid Cal/Mag, CMO (Cetyl Myristoleate), Colloidal Silver, 4-Herb Tea Bulk, 4-Herb Concentrate, and Olive Leaf Liquid for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:
For HHA CMO (Cetyl Myristoleate) on the webpage https://www.herbalhealer.com/cmo/:
? “Cetyl Myristoleate helps with my fibromyalgia!”
For HHA Colloidal Silver (1 gallon) on the webpage https://www.herbalhealer.com/colloidal-silver-1-gallon/:
? “I used to get frequent bladder infections and took antibiotics far too often. Colloidal silver worked faster for me, my daughter, and everyone else I have told about it who tried it. It also helped us for sinus problems when used as nose drops.”
For HHA Colloidal Silver (2 ounce) on the webpage https://www.herbalhealer.com/colloidal-silver-2-ounce/:
? “Been using this product for about 15 years now , amazing results, from curing a major topical staph infection, to just a cold works wonders thx HHA y ’all rule!!!”
? “It works very well for multiple sub-clinical infections / allergies. This is a fantastic product and everyone needs colloidal silver in your alternative medicine cabinet.”
For HHA 4-Herb Tea Bulk:
? On the webpage https://www.herbalhealer.com/4-herb-tea-bulk/?revpage=3 #product-reviews:
o “I have Severe Chronic Fatigue Syndrome with Fibromyalgia and if it were not for me drinking this 4 Herb Bulk Tea, I would be rendered bedridden. It has made a dramatic change in my life where I can be a functioning person now.”
? The product web page for 4-Herb Tea Bulk at https://www.herbalhealer.com/4- herb-tea-bulk/ afterclicking on the phrase “Click here some of our customer reports on the 4-Herb Tea!” directs to a document entitled “Reports on Effectiveness of the 4-Herb Formula” at https://www.herbalhealer.com/content/4herb/4herbreports.pdf:
o “Member with an inoperable brain tumor and Krohn’s [sic] disease . She reports having had radiation and chemotherapy. After only three weeks taking the herbs 3 times a day, this is what she reports. "Chronic diarrhea has just about stopped (8 months constant) - 85% improvement! Constant head pains diminished - thinking clear - reduced medication 65-70%!!!”
o “What type of illness being treated? DIABETES - dose - 2 ounces of tea daily - "Blood sugar was at start 265 - in three days the blood sugar was 103 - After 6 weeks the blood sugar is still 103-105…Would you say it is formula helped the ailment that was treated? "Quite so- Remarkable!”
o “A health care professional who makes up the formula and uses it on patients and family reported a couple of fascinating cases. The first was an elderly man dying of cancer. He was in a great deal of pain and had to be given 360 mg. of morphine on a regular basis. She put him on the 4 herb formula. He began to hallucinate, so she suggested that the morphine be withheld until he specifically asked for it. He was asked on a regular basis [i]f he needed any pain medication and he said no. This patient did die, however, he died completely free from pain killers. The 4 herb formula was able to relieve all his pain….”
For HHA 4-Herb Concentrate on the webpage https://www.herbalhealer.com/4-herbconcentrate/:
? “This product was responsible for hugely reducing cancer when my husband was diagnosed with prostrate [sic] cancer. I trust it 500 per cent and am giving it to my husband to hopefully kill the bone infection he now has. You can't get any better than Herbal Healer products!”
For HHA Olive Leaf Liquid on the webpage https://www.herbalhealer.com/olive-leafliquid/:
? “I have taken olive leaf extract for almost twenty years and haven't had a cold in all these years or the stomach flu. Twenty years ago my blood pressure was getting high and I think I had diabetes, never confirmed by a doctor, but I had terrible neuropathy in my feet and legs. My heart was enlarged and I had parasites and high cholesterol. I now have a normal size heart, normal blood pressure, no parasites and my cholesterol is good nd [sic] all my arteries are clean. No more neurophy [sic], that was the first thing that went away when I started the olive leaf…”
Examples of some of the claims within your product catalog that provide evidence that your products are intended for use as drugs include:
HHA Colloidal Minerals
? “Mineral deficiency can result in over 600 diseases, illnesses, and disabilities? Here is a list of some ailment links to mineral deficiencies so you can get an idea of the extreme importance of getting mineral supplementation…”
? “AILMENTS- … ANEURYSMS … ATTENTION DEFICIT DISORDER (ADD) … BIRTH DEFECTS … CANCER … HYPERACTIVITY … INFERTILITY…”
HHA Marine Sea Cucumber
? “Natural anti-inflammatory and nutritional support for arthritis…”
HHA Herbalgesic
? “For pain & inflammation. Natural aspirin formulation.”
HHA U.T. Clear
? “For acute or chronic urinary tract infections…”
HHA Olive Leaf Extract
? “This is the best anti-viral natural medicine…”
? “Anti-fungal, anti-viral. This product is used for very difficult cases...”
HHA Flew Away
? “Use this with any flu viral infection...”
HHA 4-Herb Tea
? “Has proven very effective in diabetic support...”
? “Has proven very effective because it flushes the liver. Depression is linked to liver toxicity and chemical imbalance...”
Your HHA CMO (Cetyl Myristoleate), HHA Colloidal Silver, HHA 4-Herb Tea Bulk, HHA 4-Herb Concentrate, Apricot Kernels, HHA Olive Leaf Liquid, HHA 5-HTP, HHA Herbalgesic, HHA CoQ10 with Hawthorn Berry, HHA Glucosamine & Chondroitin, Angiostop, HHA Beta Glucans, HHA Prostate Support, The Healing Formula Wound Care, HHA Colloidal Minerals, HHA Marine Sea Cucumber, HHA U.T. Clear, HHA Olive Leaf Extract, HHA Flew Away, and HHA 4-Herb Tea 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)]. 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 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 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 HHA CMO (Cetyl Myristoleate), HHA Colloidal Silver, HHA 4-Herb Tea Bulk, HHA 4-Herb Concentrate, Apricot Kernels, HHA Olive Leaf Liquid, HHA 5-HTP, HHA CoQ10 with Hawthorn Berry, HHA Beta Glucans, HHA Prostate Support, The Healing Formula Wound Care, HHA Colloidal Minerals, and HHA 4-Herb Tea 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 HHA CMO (Cetyl Myristoleate), HHA Colloidal Silver, HHA 4-Herb Tea Bulk, HHA 4-Herb Concentrate, Apricot Kernels, HHA Olive Leaf Liquid, HHA 5-HTP, HHA CoQ10 with Hawthorn Berry, HHA Beta Glucans, HHA Prostate Support, The Healing Formula Wound Care, HHA Colloidal Minerals, and HHA 4-Herb Tea 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)].
Further, according to 21 CFR 310.548, any OTC drug product containing colloidal silver ingredients that is labeled, represented, or promoted for the treatment and/or prevention of any disease (e.g., your HHA Colloidal Silver product) is regarded as a “new drug” within the meaning of section 201(p) of the Act for which an approved application is required for marketing, without which such product is also misbranded under section 502 of the Act [21 U.S.C. 352].
Misbranded Homeopathic Drugs
FDA reviewed the product label of Herbal Healer Parasite Detox obtained during the FDA inspection of your facility. In addition, FDA reviewed your website www.herbalhealer.com. Your firm’s products Herbal Healer Parasite Detox, Apis Mel, Cantharis, Cataract Drops, Glaucoma Formula, Natrum phos, Homeopathic Parasite Detox, and Sabal Serrulata (a/k/a Saw Palmetto [Sabal Scrr]) are drugs under section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)], because they are intended to diagnosis, cure, mitigate, treat, or prevent disease and/or intended to affect the structure or any function of the body.
Claims demonstrating the intended uses for Herbal Healer Parasite Detox, Apis Mel, Cantharis, Cataract Drops, Glaucoma Formula, Natrum phos, Homeopathic Parasite Detox, and Sabal Serrulata include, but may not be limited to, the following:
? Herbal Healer Parasite Detox –
o “Parasite Detox” (Product name)
o “Worming Children & Elderly” (Instructions on your leaflet that accompanies your product)
? Apis Mel – “Edema in any part of the body, kidney disorders; ovarian and uterine inflammations.”
? Cantharis – “For inflamed and irritated urinary organs; ulcerative pain; inflammation of the bowels with diarrhea.”
? Cataract Drops – “Cataract Drops” (Product name)
? Glaucoma Formula – “Glaucoma Formula” (Product name)
? Natrum phos – “Chronic rheumatism”
? Homeopathic Parasite Detox
o “Assists in the elimination of intestinal parasites for all ages.”
o “Parasite Detox” (Product name)
? Sabal Serrulata
o “Homeopathic Use: Irritation of genito-urinary organs; simple cases of enlarged or irritated prostate, ovaries; urinary difficulties.”
o “Palliation of prostatic irritation and enlargement, causing difficult urination. Catarrhal of the bladder.”
We recognize that Herbal Healer Parasite Detox, Apis Mel, Cantharis, Cataract Drops, Glaucoma Formula, Natrum phos, Homeopathic Parasite Detox, and Sabal Serrulata are represented as being homeopathic drugs with active ingredients measured in homeopathic strengths. Under section 201(g)(1) of the 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 drugs are subject to the same regulatory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, labeling, misbranding, or approval.
We acknowledge that many homeopathic drugs are manufactured and distributed without FDA approval under enforcement policies set out in the FDA’s Compliance Policy Guide (CPG) entitled, Conditions Under Which Homeopathic Drugs May be Marketed (CPG 400.400). As its title suggests, the CPG identifies specific conditions under which homeopathic drugs may ordinarily be marketed; thus, in order to fall under the enforcement policies set forth in the CPG, a homeopathic product must meet the conditions set forth in the CPG. One of those conditions is compliance with section 503(b) of the Act. The CPG states that homeopathic products intended solely for self-limiting disease conditions amenable to self-diagnosis (of symptoms) and treatment may be marketed Over-the-Counter (OTC). Homeopathic products offered for conditions not amenable to OTC use must be marketed as prescription products. Section 503(b)(1) of the Act [21 U.S.C. § 353(b)(1)] identifies criteria for determining the prescription drug status of a product.
Your above named products are prescription drugs as defined in section 503(b)(1)(A) of the FD&C Act [21 U.S.C. § 353(b)(1)(A)], because in light of their toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to their use, they are not safe for use except under the supervision of a practitioner licensed by law to administer such drug. Therefore, these products are misbranded under section 503(b)(4) of the Act [21 U.S.C. § 353(b)(4)], in that their labels fail to bear the symbol, “Rx only.”1 The introduction or delivery for introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
Adulterated Dietary Supplements
During the November 5 through November 9, 2018, inspection, our investigators observed the following significant violations of FDA’s Current Good Manufacturing Practice (CGMP) requirements for dietary supplements, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111), which render your dietary supplement products adulterated under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)]. Even if your HHA 4-Herb Tea Bulk and HHA Colloidal Silver products did not have therapeutic claims which make them unapproved new drugs and misbranded drugs, these products would be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. §342(g)(1)] because they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.
We acknowledge receipt of your written response, received on November 28, 2018, to the observations reported to you on the Form FDA-483, Inspectional Observations, which was issued to you on November 9, 2018.
The significant violations documented during the inspection include, but are not limited to, the following:
1. You failed to collect and hold reserve samples of each lot of packaged and labeled dietary supplements that you distributed, as required by 21 CFR 111.83(a). Specifically, our investigator observed that you did not collect and hold reserve samples for each lot of packaged and labeled dietary supplement products that you distribute. For each lot of packaged and labeled supplements that you distribute, you must collect reserve samples and hold the samples in accordance with 21 CFR 111.83(b) and 21 CFR 111.465. Specifically, the reserve samples that you maintain must:
? Be held using the same container-closure system in which the packaged and labeled dietary supplements were distributed [21 CFR 111.83(b)(1)].
? Be identified with the appropriate batch, lot, or control number [21 CFR 111.83(b)(2)].
? Be retained for one year past the shelf life date (if shelf life dating is used), or for two years from the date of distribution of the last batch of dietary supplement associated with the reserve sample, for use in appropriate investigations [21 CFR 111.83(b)(3)].
? Consist of at least twice the quantity necessary for all tests or examinations to determine whether or not the dietary supplement meets product specifications [21 CFR 111.83(b)(4)].
? Be held in a manner that protects against contamination and deterioration, including under conditions consistent with product labels or, if no storage conditions are recommended on the label, under ordinary storage conditions [21 CFR 111.465(a)(1)].
We have reviewed your November 28, 2018 written response letter. However, we are unable to evaluate the sufficiency of your corrective action. During the inspection, you created a new procedure entitled “SOP Holding/Reserve” and provided a copy to our investigator. Your written response also includes a
procedure entitled “SOP Holding/Reserve” that differs from the one provided to our investigator.. However, this procedure does not fulfill all the requirements of 21 CFR part 111 regarding the reserve samples. For example, your procedure does not address the holding of the sample in a manner to protect against contamination and deterioration. Furthermore, your response does not provide documentation demonstrating that you have started collecting and holding reserve samples for each lot of all the packaged and labeled dietary supplement products that you distribute.
2. You failed to establish and follow written procedures to fulfill the requirements related to returned dietary supplements, as required by 21 CFR 111.503. Specifically, you did not establish written procedures for returned dietary supplements. Once you have established written procedures for returned dietary supplements, you must make and keep records of these written procedures, as required by 21 CFR 111.535.
We have reviewed your November 28, 2018 written response letter. However, we are unable to evaluate the sufficiency of your corrective action. During the inspection, you created a new procedure entitled “SOP Returns” and provided a copy to our investigator. Your written response also includes a procedure entitled “SOP Returns” that differs from the one provided to our investigator and includes a blank monitoring record entitled “Returns”.. However, this procedure does not fulfill all the requirements of 21 CFR part 111, Subpart N – Returned Dietary Supplements. For example, your procedure does not require you to identify and quarantine returned supplements until quality control personnel conduct a material review and make a disposition decision, as required by 21 CFR 111.510. Your procedure also does not require you to make and keep records of any material review and disposition decision, as required by 21 CFR 111.535(b)(2), or to conduct an investigation of the manufacturing processes if the reason for the return of the supplement implicates other batches, as required by 21 CFR 111.530. The “Returns” monitoring record provided also does not address these issues.
Misbranded Dietary Supplements
Even if your HHA 4-Herb Tea Bulk and HHA Colloidal Silver products did not have therapeutic claims which make them unapproved new drugs, these products would be 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 HHA 4-Herb Tea Bulk product is misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the label fails to accurately declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7 and 15 U.S.C. § 1453(a)(2) of the Fair Packaging and Labeling Act. The product label declares the net quantity in avoirdupois pound and ounce but fails to declare the net quantity in metric terms. Furthermore, the term "net weight" shall be used when stating the net quantity of contents in terms of weight.
2. Your HHA 4-Herb Tea Bulk product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Your product label declares the dietary ingredient turkey rhubarb (Rheum palmatum), but turkey rhubarb is not the standardized common name noted in the reference Herbs of Commerce.
3. Your HHA 4-Herb Tea Bulk and Colloidal Silver 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 label is incorrect. Specifically:
? Your HHA Colloidal Silver product labels’ directions of use suggest ½ teaspoon, twice daily, but the serving size lists 1 tsp. 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. Therefore, the serving size listed should be ½ teaspoon, and the quantitative amount per serving listed for the dietary ingredient must be adjusted accordingly.
? Your HHA 4-Herb Tea Bulk product’s Supplement Facts label fails to declare the serving size for the unprepared product. Furthermore, the serving size shall be expressed as a common household measure followed in parenthesis by the equivalent metric quantity in accordance with 21 CFR 101.9(b)(7). For products that only require the addition of water or another ingredient that contains insignificant amounts of nutrients in the amount added and that are prepared in such a way that there are no significant changes to the nutrient profile, the amount of the finished product may be declared in parentheses at the end of the serving size declaration (e.g., 1/2 cup (120 mL) concentrated soup (makes 1 cup prepared)). [21 CFR 101.9(b)(7)(v)]
4. Your HHA Colloidal Silver products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. 343 (q)(5)(F)] in that the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. For example, the Supplement Facts label fails to declare the quantitative amount per serving of the dietary ingredient colloidal silver. The amount is listed as “500 ppm” which is a measurement of concentration; 500 ppm equals 500 mg colloidal silver per 1 liter of the product. However, the serving size of your product is not 1 liter.
5. Your HHA 4-Herb Tea Bulk product is misbranded within the meaning of section 403(s)(2)(C) of the Act [21 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). Your product label fails to identify the part of the sheep sorrel herb used in the product.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above 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 correct the violations cited in this letter. Failure to correct these violations may result in legal action without further notice, including, without limitation, seizure and/or injunction.
We also offer the following comments:
1. Your HHA 4-Herb Tea Bulk and Colloidal Silver product labels’ statement of identity of “Dietary Supplement” is not presented in a size reasonably related to the most prominent printed matter on the principal display panel as required by 21 CFR 101.3(d).
2. Your HHA 4-Herb Tea Bulk product label’s listed number of servings per container does not appear to be consistent with the product directions and the probable yield of the prepared product. Serving size shall be determined in accordance with 21 CFR 101.9(b) and 21 CFR 101.12(b), Table 2, as required by 21 CFR 101.36(b)(1)(i).
3. Your HHA 4-Herb Tea Bulk and Colloidal Silver product labels do not bear a symbol next to the structure/function claims linking the claims to the disclaimer, as required by 21 CFR 101.93(d).
4. During our inspection, we collected product labels for several products that you state that you distribute and that are promoted as containing cannabidiol (CBD). The labeling for some of those products suggests that they are intended to be marketed as dietary supplements. Those products are: “Plus + CBD oil Spray 1 mg CBD per serving,” “Plus + CBD oil Spray 3 mg CBD per serving,” “Plus + CBD oil Capsules 10 mg CBD per serving,” and “Plus + CBD oil Capsules 15 mg CBD per serving products.” The labels for these products all include a “Dietary Supplement” statement of identity. In addition, the labels contain a Supplement Facts panel and state that the products should be used “as a dietary supplement.” Based on these observations, it appears these products are intended to be marketed as dietary supplements. However, they cannot be dietary supplements because they do not meet the definition of a dietary supplement under sections 201(ff)(3)(B) and 201(ff)(2)(A)(i) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B) and 321(ff)(2)(A)(i).
FDA has concluded based on available evidence that CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i) and (ii). Under those provisions, if an article (such as CBD) is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act, 21 U.S.C. 355, or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement. There is an exception if the substance was “marketed as” a dietary supplement or as a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for CBD.2 FDA is not aware of any evidence that would call into question its current conclusion that CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, but you may present FDA with any evidence that has bearing on this issue.
In addition, during our inspection we also collected product labels for additional CBD products that you state that you distribute and that appear to be marketed as conventional foods. These products are “CBD EDIBLES Sweet & Relaxing 200 MG Assorted Flavors Froggies” and “RELAX BEARS CBD DAILY DOSE GUMMIE 300 MG.” The label for the “Froggies” product refers to the products as “candy,” and the label for the “RELAX BEARS” product bears a Nutrition Facts panel. You should be aware that it is a prohibited act under section 301(ll) of the Act (21 U.S.C. 331(ll)) to introduce or deliver for introduction into interstate commerce any food to which has been added a drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, unless the drug was marketed in food before any substantial clinical investigations involving the drug were instituted. The existence of substantial clinical investigations regarding CBD has been made public. Based on available evidence, FDA has concluded that section 301(ll) prohibits the introduction into interstate commerce of any food to which CBD has been added.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct 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 action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. If you do not believe that your products are in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection related costs.
Your written response should be sent to Chad J. Whitwell, Compliance Officer, U.S. Food and Drug Administration, 4040 North Central Expressway, Suite 300, Dallas, TX 75204. If you have questions regarding any issues in this letter, please contact Mr. Whitwell at 214-253-5328.
Sincerely,
/S/
Edmundo Garcia, Jr.
Program Division Director HAF West 3
Dallas District Director
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1 CPG 400.400 states that, in accordance with 503(b)(1) of the FD&C Act, homeopathic drug products offered for conditions that require diagnosis or treatment by a licensed practitioner must bear the prescription legend, “Caution: Federal law prohibits dispensing without prescription.” This CPG was issued by the agency in 1988. In 1997, Congress enacted the Food and Drug Administration Modernization Act (FDAMA); section 126 of FDAMA amended 503(b)(4) of the FD&C Act to require that the label of a prescription drug must bear, at a minimum, the symbol “Rx only.”
2 CBD is the active ingredient in the approved drug product Epidiolex. Furthermore, the existence of substantial clinical investigations regarding CBD has been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex and Epidiolex. (See Sativex Commences US Phase II/III Clinical Trial in Cancer Pain and GW Pharmaceuticals Receives Investigational New Drug (IND) from FDA for Phase 2/3 Clinical Trial of Epidiolex in the Treatment of Dravet Syndrome). FDA considers a substance to be “authorized for investigation as a new drug” if it is the subject of an Investigational New Drug application (IND) that has gone into effect. Under FDA’s regulations [21 CFR 312.2], unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the FD&C Act.