Mr. Samuel Young
- Country Doctor Herbals
1809 Logan Ave
Cheyenne, WY 82001
- Issuing Office:
- Denver District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Denver District Office|
Building 20- Denver Federal Center
P.O. Box 25087
Denver, Colorado 80225-0087
June 10, 2015
VIA UPS PRIORITY
Daniel V. Young
Country Doctor Herbals
1809 Logan Avenue
Cheyenne, WY 82001-5007
Ref: # DEN-15-12-WL
Dear Mr. Young:
On December 15-17, 2014, the U.S. Food and Drug Administration conducted an inspection of your manufacturing facility located at 1809 Logan Avenue, Cheyenne, Wyoming 82001-5007.
Based on the inspection, a review of the product labels collected during the inspection, and a review of your websites at countrydoctorherbal.us and countrydoctornutritionalcenter.us, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You may find the Act and FDA regulations through links on FDA’s website at www.fda.gov
Unapproved New Drugs/Misbranded Drugs
Based on our review of your products’ labels and your websites, countrydoctorherbal.us and countrydoctornutritionalcenter.us, in March 2015, we have determined that the claims on your labels and websites establish that several of your firm’s products are drugs within the meaning of section 201(g)(1)(B) and/or (g)(1)(C) of the Act [21 USC § 321(g)(1)(B) and/or (g)(1)(C)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease and/or are articles (other than food) intended to affect the structure or any function of the body. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. In addition to the claims noted on the immediate product labels, we note that claims are found on your websites for your products as noted below. We have determined that you take orders for each of the products listed in this section from your countrydoctornutritionalcenter.us website, and your countrydoctorherbal.us links directly to your countrydoctornutritionalcenter.us website.
Examples of some of the claims observed on your product labeling include:
On product labels:
Herbal Flu Be-Gone
- “All natural herbal formula that works to rid the body of flu”
- “A dietary formula of all natural herbs working as a broad spectrum antibac-terial[sic].”
- “All natural herbal formula that works to relieve…insomniaand anxiety.”
- “All natural herbal formula that works to relieve various aches and pains.”
- “All natural herbal formula that helps balance blood sugar.”
Herbal Parasite Cleanse
- “All natural herbal formula that works to rid the body of parasite infestation.”
Herbal Perfect Heart
- “All natural herbal formula that works to treat the primary cause of heart disease and not just the symptoms.”
- “Natural herbal formula that works to relieve sinus, hay fever and allergy problems.”
- “All natural herbal formula that works as a broad spectrum anti-viral and natural anti-biotic”
Herbal Yeast Redux
- “All natural herbal formula that works to eliminate systemic yeast infections, fungus infections and relieve leaky-gut”
- “The most effective all natural penetrating pain and healing oil…”
From the Country Doctor Herbal website, countrydoctorherbal.us (Note: the .com website automatically redirects to the .us site):
H/P Yeast Redux
- “The following symptoms can mask an underlying Candida infection…Protocol for Treatment…H/P Yeast Redux…”
Herbal Perfect Parasite Cleanse
- “Parasite Cleanse….PRODUCTS NECESSARY FOR FLUSH: Herbal Perfect Parasite Cleanse…For patients with severe or chronic parasite infections…”
From the Country Doctor Nutritional Center website, countrydoctornutritionalcenter.us
(Note: the .com website automatically redirects to the .us site):
HERBAL PERFECT CAYENNE (CAPSULE OR TINCTURE)
- “Aids in regulating blood pressure…prevents blood clots, dissolves blood clots… lowers cholesterol”
- “FIRST AID REMEDY: Use as many droppers full as necessary for heart attack, stroke, fainting, shock, dizziness, hemorrhage, internal and external bleeding, wounds, gun shot wounds, hypothermia, frost bite, ulcers, colitis, sore throat, and strep throat…”
COUNTRY DOCTOR BIOFLORA (CAPSULE ONLY)
- “Aids in prevention of parasites… Helps lower high cholesterol, prevents frequent colds/flu, chronic fatigue…”
HERBAL PERFECT S-ZYMES (CAPSULE ONLY)
- “An enzymatic formula designed to eliminate inflammation…”
HERBAL PERFECT HEAVY METAL DETOX (CAPSULE OR TINCTURE)
- “[K]nown to eliminate excess aluminum, antimony, arsenic, barium, cadmium, copper, lead, mercury, nickel, radium, thallium and uranium…”
HERBAL PERFECT ICF #1 (INTESTINAL CLEANSING FORMULA) (CAPSULE ONLY)
- “[E]xpels intestinal parasites… and is anti-bacterial, anti-viral and anti-fungal…”
HERBAL PERFECT ICF #2 (INTESTINAL CLEANSING FORMULA) (CAPSULE OR POWDER)
- “[R]emove accumulated poisons, toxins, parasites and heavy metals… an excellent remedy for any inflammation in the intestines such as diverticulitis or irritable bowel…”
HERBAL PERFECT KIDNEY/BLADDER (CAPSULE OR TINCTURE)
- “[D]isinfectant (kills infections)… destroy bacteria causing kidney and bladder infection…”
HERBAL PERFECT K/B (CAPSULE OR TINCTURE)
- “[T]o dissolve stubborn stones and calculi, to heal and eliminate infection…”
HERBAL PERFECT LIVER/GALLBLADDER (CAPSULE OR TINCTURE)
- “Milk thistle has phytochemicals that bind to, and coat, the liver cells reversing previous damage and protecting from future damage. Barbary root acts as a natural antibiotic… Ginger root inhibits bacterial growth, Golden Seal root has antiviral and antibiotic properties…”
HERBAL PERFECT LYMPH DETOX (CAPSULE OR TINCTURE)
- “proven to break up, destroy and dissolve all types of tumors…”
HERBAL PERFECT PARASITE CLEANSE (CAPSULE OR TINCTURE)
- “strong anti-parasitical”
HERBAL PERFECT B-F-C (BONE/FLESH/CARTILAGE) (CAPSULE OR TINCTURE)
- “[R]emedy to aid healing of bone, flesh and cartilage. Excellent for broken bones, spinal curvature, calcium spurs…and osteoporosis…”
COUNTRY DOCTOR DHEA (CAPSULE ONLY)
- “[M]ay help . . . treat osteoporosis”
HERBAL PERFECT PROSTATE (CAPSULE OR TINCTURE)
- “[R]educe swelling, reduce inflammation and heal infection in the prostate…”
HERBAL PERFECT WILD YAM (TINCTURE ONLY)
- “[I]nflammation… relieves pain…”
HERBAL PERFECT NERVINE (CAPSULE OR TINCTURE)
HERBAL PERFECT RESP-FREE (CAPSULE OR TINCTURE)
- “Relieves congestion, inflammation, irritation and infection of the respiratory tract, the bronchi and lungs. This herbal combination will help repair and rebuild the respiratory tract from the ravages of asthma, bronchitis, coughs (Smokers coughs), croup, emphysema, pleurisy, pneumonia, tuberculosis…”
HERBAL PERFECT SHA (SINUS/HAYFEVER/ALLERGIES) (CAPSULE OR TINCTURE)
- “An all natural herbal product working as a decongestant and natural antihistamine to open and dry the sinuses. Acts as decongestant to remove mucous [sic] from the head, bronchial and pulmonary areas…”
COUNTRY DOCTOR B-COMPLEX 100 (CAPSULE ONLY)
- “[H]elpful for all the following conditions:…depression…insomnia…”
COUNTRY DOCTOR CoQ10 (CAPSULE ONLY)
- “Helps to lower blood pressure… used extensively in treatment and prevention of heart disease. Helps reduce side effects of chemotherapy. Has the ability to counter histamines, benefiting those with allergies, asthma, or respiratory problems. Enhances treatment of periodontal disease, diabetes and muscular dystrophy. Used to treat mental conditions associated with schizophrenia and Alzheimer's. Has been found to be beneficial in the treatment of obesity, Candida, multiple sclerosis, diabetes, and chronic fatigue syndrome.”
HERBAL PERFECT ECHINACEA (CAPSULE OR TINCTURE)
- “natural antibiotic, antiviral and antifungal”
HERBAL PERFECT EYEBRIGHT (CAPSULE OR TINCTURE)
- “[D]estroys bacterial infections, and reverses eye disease…”
HERBAL PERFECT FLU-B-GONE (CAPSULE OR TINCTURE)
- “[T]o combat flu like viral infections. This product has been found to be effective in the treatment of asthma, bronchitis, influenza and sinusitis.”
HERBAL PERFECT LOBELIA (TINCTURE ONLY)
- “relief of… angina pectoris…convulsions…eczema, epilepsy, fevers…inflammation…”
HERBAL PERFECT PAIN-A-WAY (CAPSULE OR TINCTURE)
- “An all natural herbal formula to relieve and eliminate headaches almost instantly without any after effects or side effects common to over-the-counter drugs.”
HERBAL PERFECT PANCREAS (CAPSULE OR TINCTURE)
- “An all natural herbal product to aid in blood sugar problems (diabetes or hypoglycemia)…”
HERBAL PERFECT TOOTH AND GUM (CAPSULE OR TINCTURE)
- “Stops bleeding gums due to plaque build up. Stops and reverses gingivitis damage to the teeth and gums. This product is antibacterial and antifungal and will destroy oral infections upon contact…”
HERBAL PERFECT VIREX (CAPSULE OR TINCTURE)
- “A broad spectrum, natural herbal combination which is antiviral and antibiotic in its medicinal properties. Used in the treatment of staph, strep, viral infections of all types including the hepatitis virus, Coxsacki virus, influenza and cold virus, Herpes, shingles and HIV to name a few.”
HERBAL PERFECT YEAST REDUX (CAPSULE OR TINCTURE)
- “Herbal Perfect Yeast Redux is a broad spectrum combination of antifungal herbs designed to kill any systemic yeast or fungal infection. Some of the symptoms of a systemic fungal infection are vaginal yeast infections, prostatitis, athlete's foot, ring worm, jock itch, chronic fungal infections of skin or nails.”
- “A powerful healing and pain relieving oil used very effectively to reduce inflammation and stiffness of painful joints, tendons, ligaments, cartilage and muscles. Works to relieve pain and begin the healing process for arthritis, bursitis, lumbago and muscle or bone pain injuries…”
- "There are many instances of individuals using this herbal remedy who have been contemplating knee replacement surgery. After using this remedy for a few weeks the cartilage in their knees began rebuilding and surgery was no longer necessary. Most of our patients are amazed at the rapid effectiveness of this healing oil...”
PERFECT B AND B (BODY AND BRAIN):
- “THERAPEUTIC ACTION: A blend of herbs used in treatment of nervous conditions, anxiety, vertigo, snoring, malfunction of the spleen, dizziness, ringing in the ears, hiccups, equilibrium problems, hearing problems and bed wetting. Restores dysfunctional motor nerves. This herbal formula that will exceed expectations when used for epilepsy and seizures...”
Your above-listed 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)(1) of the Act [21 USC § 321(p)(1)]. New drugs may not be legally marketed in the United States without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 USC §§ 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate the drug is safe and effective.
Additionally, 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 C.F.R. § 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 Herbal Nervine (Tincture), Herbal Perfect Parasite Cleanse (Capsule or Tincture), Herbal Perfect Heart (Tincture), Herbal Yeast Redux (Capsule or Tincture), Herbal Perfect Cayenne (Capsule and Tincture), Country Doctor Bioflora (Capsule), Herbal Perfect Heavy Metal Detox (Capsule or Tincture), Herbal Perfect ICF #2 (Intestinal Cleansing Formula)(Capsule or Powder), Herbal Perfect Kidney/Bladder (Capsule or Tincture), Herbal Perfect Lymph/Detox (Capsule or Tincture), Herbal Perfect B-F-C Bone/Flesh/Cartilage), (Capsule or Tincture), Country Doctor DHEA (Capsule), Herbal Perfect Prostate (Capsule or Tincture), Herbal Perfect Resp-Free (Capsule or Tincture), Country Doctor B-Complex 100 (Capsule), Country Doctor Coq10 (Capsule), Herbal Perfect Eyebright (Capsule or Tincture), Herbal Perfect Lobelia (Tincture), Herbal Perfect Pancreas (Capsule or Tincture), Herbal Perfect Virex (Capsule or Tincture), Pain-A-Trate (Tincture), and Herbal Perfect B and B (Tincture) products are intended for prevention or treatment or one or more diseases that are not amenable to self-diagnosis or treatment. Therefore, it is impossible to write adequate directions for a layperson to use these products safely for their intended purposes. Accordingly, these products fail to bear adequate directions for their intended use and, therefore, 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)).
Dietary Supplement CGMP Violations
Each of the dietary supplement products that you manufacture, package, label, and/or hold is adulterated within the within the meaning of section 402(g)(1) of the Act [21 U.S.C. §342(g)(1)] because the products have been prepared, packed, or held under conditions that do not meet the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). Additionally, even if the products identified in the “Unapproved New Drugs/Misbranded Drugs” portion of this letter were not unapproved new drugs, they would be adulterated dietary supplements within the meaning of section 402(g)(1) of the Act [21 U.S.C. §342(g)(1)].
The significant violations documented during the inspection include, but are not limited to, the following:
1. You failed to establish and follow written procedures for the responsibilities of quality control operations, including written procedures for conducting a material review and making a disposition decision, as required by 21 CFR 111.103 and 21 CFR 111.140(b)(1). Specifically, you have not established written procedures for any responsibilities for the quality control operations at your firm.
We have reviewed your letters dated December 26, 2014, and February 4, 2015, written in response to the FDA-483 issued at the close of our inspection. Your December 2014 response includes a document titled “Laboratory Processes and Procedures,” which states, under the section for 21 CFR 111.105, that your quality control unit is responsible for “observation, (b)(4) training, periodic audits on documentation, monitoring reserve samples and determining whether all specifications . . . are met.” While we acknowledge your steps towards compliance with the Dietary Supplement CGMP Regulations (21 CFR 111), your response cannot be evaluated because the document fails to describe specific procedural steps for your quality control personnel to perform.
2. You failed to establish finished product specifications for identity, purity, strength, and composition for the finished batch of each dietary supplements you manufacture, as required by 21 CFR 111.70(e). Specifically, you have not established finished product specifications for the identity, purity, strength, composition and limits on contamination for any of the dietary supplement products you manufacture. Once you have established the required specifications, you must verify your finished dietary supplements meet those product specifications for identity, purity, strength, or composition, as required by 21 CFR 111.75(c).
In your response dated December 26, 2014, you included a blank form on which you plan to make organoleptic observations. In addition, you provided a document titled “Laboratory Policies and Procedures,” which describes in several locations the “physical examination” of all finished product by a “laboratory technician, offsite expert and offsite laboratory.” Your response also states, “Products must pass a purity, strength and composition test from an offsite independent laboratory.” Your response, however, does not include finished product specifications. Your response cannot be evaluated because it does not include the specific tests or acceptance criteria related to the identity, purity, strength, and composition of each dietary supplement you manufacture.
3. You failed to establish component specifications that are necessary to ensure that specifications for the purity, strength, and composition of dietary supplements manufactured using components are met, as required by 21 CFR 111.70(b)(2). Specifically, you have not established specifications for any of the components, including dietary ingredients, used in the production of the dietary supplement products you manufacture.
We have reviewed your response letter, dated December 26, 2014, but are unable to evaluate your response, which does not provide the component specifications that you have established. Additionally, you state in your response letter, “All ingredients must come with a certification, identification number, pass a physical examination of the onsite laboratory technician as well as the offsite expert.” Note that once you have established appropriate specifications and before using a component that is a dietary ingredient, you must conduct at least one appropriate test or examination to verify the identity of the dietary ingredient prior to its use, unless you petition FDA for an exemption, as required by 21 CFR 111.75(a)(1)(i). A Certificate of Analysis may not be used in lieu of an identity test. You must also ensure that the tests and examinations that you use to determine whether the specifications are met are appropriate, scientifically valid methods, as required by 21 CFR 111.75(h)(1).
4. You failed to prepare and follow a written 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 under 21 CFR 111.205(a). Specifically, you have not prepared an MMR for any of the dietary supplement products that you manufacture.
We have reviewed your response letter, dated December 26, 2014, in which you submitted a blank “Intake Manufacturing Form.” This form appears to represent your master manufacturing record template. We acknowledge your efforts to comply with requirements for master manufacturing records under 21 CFR 111.210; however, your proposed MMR remains incomplete, as you have not addressed all of the elements required by 21 CFR 111.210. For example, your record titled “Intake Manufacturing Form,” once filled in for each unique formulation of dietary supplement you manufacture, and for each batch size, does not include written instructions covering the step-by-step processes needed at each point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record; procedures for sampling and a cross-reference to procedures for tests or examinations; specific actions including verification of the weight or measure of any component and verifying the addition of any component; special notations and precautions to be followed; and specific action plans for use when a specification is not met.
5. Your firm failed to prepare a batch production record (BPR) every time you manufactured a batch of dietary supplements, as required by 21 CFR 111.255(a). Specifically, you do not prepare BPRs for any of the dietary supplement products that you manufacture; rather, you only document batch production through a log indicating the product manufactured and, occasionally, the date of production.
We have reviewed your response letter, dated December 26, 2014, in which you indicated you have established the elements required in a complete batch record. We acknowledge your efforts to comply with requirements of 21 CFR 111.260; however, we cannot evaluate your response because the “Intake Batch Form” that you appear to have developed to be your BPR is not complete for all elements required by 21 CFR 111.260. For example, the Intake Batch Form does not contain an area for documenting, at the time of performance of the manufacture of the batch, the date on which each production step from the manufacturing record was performed; the initials of the persons performing each step 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 including an actual or representative label or cross-reference to its location; and the quantity and lot number of labels used during packaging and labeling. Further, your Intake Batch Form or BPR must be specific to each batch of dietary supplement product you manufacture.
6. You failed to collect and hold reserve samples of each lot of packaged and labeled dietary supplements that you distribute, as required by 21 CFR 111.83(a). Specifically, you do not collect and hold reserve samples of any of the dietary supplement products that you distribute. You must collect and hold the required reserve samples in accordance with the procedures set forth in 21 CFR 111.83(b).
We have reviewed your response letter, dated December 26, 2014, in which you state, “each lot number is require(d) to have a reserve sample of (b)(4) kept on site for (b)(4). Your response cannot be evaluated, as it does not address the conditions under which the sample will be stored. You did not include any photographs or documents associated with reserve samples you have kept.
7. Your firm failed to make and keep records of the written procedures for manufacturing operations, as required by 21 CFR 111.375(b). Specifically, you have not established or kept records of written procedures for any manufacturing operations for any of the dietary supplement products you manufacture.
We have reviewed your response letter, dated December 26, 2014. Your response cannot be evaluated because it was not specific to the manufacturing processes conducted at your firm and did not include actual procedures. Further, even if your response included the manufacturing processes and procedures to be conducted, your “Intake Manufacturing Form” and “Intake Batch Form” do not include a reference to the Laboratory Policies and Procedures manual such that the individual performing the manufacturing process would know where to find the procedures.
8. Your firm failed to establish and follow written procedures for packaging and labeling operations, as required by 21 CFR 111.403. Specifically, you have not established written procedures for the packaging and labeling operations performed for any of the dietary supplements products you package and label. Once you have established written procedures for packaging and labeling operations, you must make and keep records of the written procedures for packaging and labeling operations, as required by 21 CFR 111.430.
We have reviewed your response letter, dated December 26, 2014. Your response indicated you have established written procedures for identifying and applying the correct label. However, your response cannot be evaluated because you failed to provide supporting documentation demonstrating that you have taken corrective action. For example, you failed to provide a procedure listing specific steps that are designed to ensure each product is packaged with the intended packaging and labeling.
9. Your firm failed to establish and follow written procedures for fulfilling the requirements for the review and investigation of product complaints, as required by 21 CFR 111.553. Specifically, you have no written procedures for the review and investigation of product complaints, nor do you have records documenting the complaints you have received, your response, or any investigation which may have been performed. Once you establish the necessary written procedures, you must make and keep records for the review and investigation of product complaints in accordance with 21 CFR 111.570.
We have reviewed your response letter, dated December 26, 2014. Your response indicated you have established written procedures for handling complaints. We acknowledge your efforts toward complying with the requirements of 21 CFR 111.553 in that you have established a procedure for handling complaints and investigations as well as a form for documenting the receipt of a complaint. However, your response cannot be evaluated because it lacks components of an adequate investigation and specific description of responsibility and complaint documentation process. For example, your procedure does not indicate who is responsible for receiving and documenting the complaint and does not include, for example, a step for evaluation of the BPR associated with the product that is the subject of the complaint as part of the complaint investigation.
10. Your firm failed to establish and follow written procedures for fulfilling the requirements for returned dietary supplements, as required by 21 CFR 111.503. Specifically, you have not established written procedures for returned dietary supplements relating to any of the dietary supplement products you distribute. Once you establish such written procedures, you must make and keep records of the dietary supplements that are returned and the disposition of those products, as required by 21 CFR 111.535(b).
We have reviewed your response, dated December 26, 2014. We acknowledge your efforts to comply with requirements of 21 CFR 111.503 in that you have established written procedures for handling product returns as well as a form to document the return; however, your response cannot be evaluated because your returned products procedure does not include sufficient detail to establish the process and steps to be taken at the time a product is returned.
Misbranded Dietary Supplements
Your Herbal Perfect Male and Herbal Nerve Regeneration products are misbranded dietary supplement under section 403 of the Act [21 U.S.C. § 343] because they do not comply with the labeling requirements for dietary supplements. Additionally, even if your Herbal Flu Be-Gone product was not an unapproved new drug, it would still be a misbranded dietary supplement within the meaning of section 403 of the Act [21 U.S.C. §343].
1. Your Herbal Flu Be-Gone, Herbal Perfect Male, and Herbal Nerve Regeneration products are misbranded within the meaning of section 403(i)(2) of the Act in that the product 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. Specifically, your products are extracts of herbs, not the actual herbs. Therefore, the common or usual name for these ingredients must include the term “extract”. Further, the ingredient statement for the proprietary blends may include intervening material such as the statement: “wild crafted…”
2. Your Herbal Flu Be-Gone, Herbal Perfect Male, and Herbal Nerve Regeneration products are misbranded within the meaning of section 403(q)(1)(A) because the serving size declared on the label is 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. Specifically, your product labels indicate a Serving size of 30 drops according to the Supplement Facts labels. However, your “Suggested Dosage” for these products state directions of “30 to 60 drops in 2 ounces of water 2 to 4 times daily”, “2 droppers full in 2 ounces of water 3 to 4 times daily.”, or “2 droppers full 3 times daily.” Furthermore, we note that your website indicates dosages of up to 6 droppers full four times a day (Flu-B-Gone) and up to four droppers full before engaging in sexual activity (Herbal Perfect Male). We note that your website’s FAQ information indicates that “one dropper full” is 30-35 drops.
3. Your Herbal Flu Be-Gone, Herbal Perfect Male, and Herbal Nerve Regeneration products are misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)] because the labels fail to identify the products using the term “dietary supplement” as required by 21 CFR 101.3(g).
4. Your Herbal Flu Be-Gone, Herbal Perfect Male, and Herbal Nerve Regeneration products are misbranded within the meaning of Section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)] in that they fail to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. Specifically, the product labels are lacking the zip code of the facility location.
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility or 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 and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Additionally, we have the following comment regarding the production and distribution of certain dietary supplement products. To the extent you receive products from a supplier for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier), you must establish specifications to provide sufficient assurance that the product you receive is adequately identified and is consistent with your purchase order, as required by 21 CFR 111.70(f). Moreover, to the extent other companies manufacture dietary supplements on your behalf as a contract manufacturer, and that your firm releases for distribution under your firm’s name, your firm has an obligation to know what and how manufacturing activities are performed so that you can make decisions related to whether your dietary supplement products conform to established specifications and whether to approve and release the products for distribution [72 Fed. Reg. 34752, 34790 (Jun. 25, 2007)]. Although a firm may contract out certain dietary supplement manufacturing operations, it cannot contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements (see United States v. Dotterweich, 320 U.S. 277, 284 (1943) (explaining that an offense can be committed under the Act by anyone who has “a responsible share in the furtherance of the transaction which the statute outlaws”); United States v. Park, 421 U.S. 658, 672 (1975) (holding that criminal liability under the Act does not turn on awareness of wrongdoing, and that “agents vested with the responsibility, and power commensurate with that responsibility, to devise whatever measures are necessary to ensure compliance with the Act” can be held accountable for violations of the Act). In particular, the Act prohibits a person from introducing or delivering for introduction, or causing the delivery or introduction, into interstate commerce a dietary supplement that is adulterated under section 402(g) for failure to comply with dietary supplement CGMP requirements (see 21 U.S.C. 342(g) and 331(a)). Thus, a firm that contracts out some or all of its operations must establish a system of production and process controls to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.55). The quality control personnel must ensure that the manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.105).
Within 15 working days of receipt of this letter, please notify this office in writing of the specific steps that 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 a corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
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 reinspection-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. Reinspection-related costs means all expenses, including administrative expenses incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
Your written response should be directed to the U.S. Food and Drug Administration, Attention: Nancy G. Schmidt, Compliance Officer, at the above address. If you have questions about this letter, please contact Mrs. Schmidt at (303) 236-3046.
LaTonya M. Mitchell
Denver District Director
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