Inspections, Compliance, Enforcement, and Criminal Investigations

Ozark Country Herbs 3/30/18

 

  

Black HHS-Blue FDA Logo

 

 

 
 

 

March 30, 2018
 
CMS # 542508
 
WARNING LETTER
 
UPS Overnight
 
Reuben M. Yoder, Owner
Edna M. Yoder, Owner
Ozark Country Herbs
2866 Highway 395 North
Salem, Arkansas 72576
 
Dear Mr. & Mrs. Yoder
 
From November 9-13, 2017, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 2866 Highway, 395 North, Salem, Arkansas 72576. Based on the inspection, a review of your product labels collected during the inspection, and a review of your mail order catalog, 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.
 
We acknowledge receipt of your undated response to the FDA 483, which was postdated November 22, 2017.  We address relevant portions of your response below.
 
Unapproved New Drugs/Misbranded Drugs
 
FDA reviewed your product labels and your firm’s mail order catalog following the November 9-13, 2017 inspection of your facility. The claims on your product labels and in your mail order catalog establish that your Complete Tissue Syrup, Allergy/Energy Combo, Natural Antibiotic (LDM), Migraine Relief, Pain Relief, Bilbrite Formula, Anti-Yeast, Dental Formula, Heart Tonic, Echinacea-Goldenseal, Lung & Respiratory, Natural Iron, Birth Ease, M.C. Formula, Hormone Health, Ladies Formula, Baby Calm, Rescue Remedy, Eldermint, Diarrhea-X, Nerve & Stress, Kidney & Bladder, Flu & Cold Aid, Cayenne, White Willow, Sinus/Hay Fever, Arthritis Relief, Gripe Water, Concentration Aid, Liver/Gallbladder, Para-Cleanse Package, Wintertime Tea, Teething Oil, Complete Tissue Oil, Deep Tissue Oil, Aloe-Vera Goldenseal Salve, Calendula Salve, Chickweed Salve, Plantain Salve, Congestion Salve, Ear Oil, and Natural Calcium 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 claims on your product labels and your mail order catalog that provide evidence that your products are intended for use as drugs include:
 
Complete Tissue Syrup:
  • “This wonderful formula . . . has the raw material the body needs to repair bone, flesh, and cartilage. Use for Breaks, Sprains, Wounds, Damaged Nerves, Backache, Arthritis, stiff aching neck, Carpel Tunnel, Tennis Elbow, Gout and much more.” 
Allergy/Energy Combo:
  • The word “Allergy” in the product’s name.
  • “May aid in chronic allergies, immune deficiency, cancer, and autoimmune conditions.”
  • “[M]odifies the effects of chemotherapy and radiation therapy.” 
Natural Antibiotic (LDM):
  • “It is sometimes called ‘Broad Spectrum Plant Antibiotics!’ It has proven very effective for any infection or inflammation, and whenever an antibiotic should be used. Use for all respiratory and urinary infections. STAPH, STREP, and Ear infections.” 
Migraine Relief:
  • The product’s name.
  • “[R]elieve and prevent migraine headaches” 
Pain Relief:
  • The product’s name.
  • “An effective herbal pain reliever. Use in place of conventional pain relievers. Also beneficial for . . . depression, anxiety . . . .”
Bilbrite Formula:
  • “[R]epair damaged vessels” 
Anti – Yeast:
  • “This is a great anti-cancer mix. It . . . kills fungi and yeast . . . . Also works well for colds and flu.” 
Dental Formula:
  • “This formula has been proven to fill in cavities and/or heal tooth pain.”
  • “Get the benefit of being ‘dewormed’ at the same time!” 
Heart Tonic:
  • “[C]lean the arteries, preventing heart attacks and strokes.”
  • “Regulates blood pressure 
Echinacea – Goldenseal:
  • “May be beneficial for all viral infections, stomach disorders, inflammation, and skin disorders. It activates white blood cells that help destroy bacteria, fungus, and virus.” 
Lung & Respiratory:
  • “This formula is extremely valuable in strengthening and healing the entire respiratory tract, and relieves irritation in the lungs and bronchials. Use for asthma and other lung conditions.”
Natural Iron:
  • “May be beneficial for anemia . . . digestive problems, and acne.”
Birth Ease:
  • “Benefits . . . include a shorter recovery time with less after-pain . . . .” 
M.C. Formula:
  • “May be beneficial as a pregnancy support whenever bleeding or cramping starts.”
  • “It contains herbs that will prevent miscarriage . . . .” 
Hormone Health:
  • “Are you or your daughter having those monthly P M S symptoms of . . . depression/anxiety . . . ? If so, this formula is for you!” 
Ladies Formula:
  • “This combination of herbs is designed for those who have a problem with infertility . . . .”
Baby Calm:
  • “An all-purpose childhood remedy – from colds and fevers . . . .” 
Rescue Remedy:
  • “[U]seful for . . . flu, fever, colds, pain . . . .”
Eldermint:
  • “A wonderful remedy for children and adults when trying to avoid the flu or when you already have it.”
  • “[K]eeps fever under control . . . also for colds . . . .” 
Diarrhea -X:
  • The product’s name.
  • “An excellent remedy to keep on hand for diarrhea."
  • “Can also be used for colds, flu and fever . . . .” 
Nerve & Stress:
  • “May be beneficial to relieve . . . depression, anxiety . . . .” 
Kidney & Bladder:
  • “This formula has been successfully used for problems with incontinence, bed-wetting, kidney stones, pain in the back caused from kidney infection . . . .” 
Flu & Cold Aid:
  • The product’s name.
  • “A great, all around, Flu & Cold remedy!”
Cayenne:
  • “Wards off diseases” 
White Willow:
  •  “[N]atural pain reliever/fever reducer” 
Sinus/Hay fever:
  • The product’s name
  • “Use for sinus congestion, headache, allergies”
Arthritis Relief:
  • The product’s name.
  • “A time-tested formula for those who suffer with Arthritis/Rheumatism or any joint pain. This combination of herbs that . . . relieve pain . . . kill fungus and infection . . . give wonderful relief.” 
Gripe Water:
  • “May aid on occasion your baby’s problems with . . . cramping . . . .” 
Concentration Aid (very calming):
  • “Especially good for children with ADD and ADHD.”
Liver/Gallbladder:
  • “When the liver does not function properly the bile does not excrete freely into the intestinal tract and so it passes off into the bloodstream causing . . . reflux and irritable bowel syndrome, headache . . . . High blood pressure, heart attack, stroke, diabetes, gallstones . . . are directly related to poor liver function. This combination of herbs was formulated to cleanse [,] nourish and support your liver . . . .”  
Para-Cleanse Package:
  • “Always start the program about 1 week before Full Moon as parasites are more active around the Full Moon.” 
Wintertime Tea:
  • “It will give your immune system the boost it needs to fight off those ‘flu bugs’. . . .”
Teething Oil:
  • “Directions: Rub on gums as needed to relieve the pain.” 
Complete Tissue Oil:
  • “Use for sore, aching joint, sprains, bruises and more.”
Deep Tissue Oil:
  • “Use to break up chest congestion and to speed healing of bruises and sprains.”
Aloe-Vera Goldenseal Salve:
  • “Heals and prevents infection in minor burns, cuts and wounds.” 
Calendula Salve:
  • “For varicose veins, fistulas, frostbites, burns, ulcers on the breast, athlete’s foot, and wounds.”
Chickweed Salve:
  • “Use for skin rashes, burns, inflammations, impetigo cuts & bruises.” 
Plantain Salve:
  • “Good for burns, diaper rash, insect bites and stings, hemorrhoids, varicose veins, open sores and more.”
Congestion Salve:
  • “A great salve when it comes to dealing with chest and head congestion, croup, pneumonia, coughs and earache.” 
Ear Oil:
  • “This is very good for ear infections.”
  • “A valuable remedy for earache and inner ear infection. To further aid pain relief or fight infection put a few drops of warm peroxide in the ear before the Ear Oil.” 
Your mail order catalog also contains evidence of intended use in the form of personal testimonials recommending or describing the use of certain products for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:
 
Testimonial for Ear Oil/Natural Antibiotic:
  • “We had to take the baby to the Dr. a number of times with inner ear infection. Now since we use peroxide and Ear Oil and also Natural Antibiotic, we have good success treating it at home . . . .”
Under the Inner Ear Infection heading:
  • “[W]e have always been successful in treating inner ear infection using the method described under Ear Oil 3-4 times daily and giving Natural Antibiotic – LDM hourly, until the fever is gone. This method will also work for common earache.”
Testimonial for Birth Ease/Natural Calcium:
  • “Since using Birth Ease and Natural Calcium, the last 5 weeks I have easier labor and birth with very little blood loss and after-pains afterwards.” 
Testimonial for Rescue Remedy:
  • “Rescue Remedy seems to work well for the flu. We like to keep it on hand as an all purpose medicine.” 
Testimonial for Eldermint:
  • “Our children love Eldermint! They call it candy medicine. I think it works well for cold and flue [sic].” 
Testimonial for Natural Antibiotic – LDM:
  • “Last week our baby was so sick we started for the hospital with her. Before we left I gave her some Natural Antibiotic – LDM and before we got there she was so much better, that we turned around and came back home.”
Testimonial for Lung & Respiratory:
  • “The Lung & Respiratory we had good results with the whooping cough. It actually worsened the cough for a few days [more mucous] but then they got better faster.” 
Testimonial for Complete Tissue Products:
  • “The Complete Tissue products have won many compliments in the past year, as more and more people realize the value of this time tested formula in healing Tennis Elbow, Back Pain, leg pain, Carpel Tunnel, Nerve Pain in teeth, sore, aching shoulder & neck & more.”
Testimonial for Heart Tonic:
  • “I had an enlarged heart, which was causing chest pain, and also had high blood pressure. I gave Heart Tonic a try. I used it pretty strong at first. Now my symptoms are good and my blood pressure stays normal.”
Testimonial for Kidney & Bladder/Natural Antibiotic:
  • “I had kidney infection and was sick in bed. I used the Kidney & Bladder formula & Natural Antibiotic every hour the first 2 days and by the 3rd day the fever had left and I was feeling better.”
Testimonial for Para-Cleanse/Quick Cleanse:
  • “Yes, I think this Para-Cleanse and Quick Cleanse did help with our 1 ½ year old. She had the pin worms so bad . . . . We wormed her pretty often with other wormer, then decided to try yours, and now she is sleeping a lot better.”
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 Act [21 U.S.C § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in Section 505(a) of the Act [21 U.S.C § 355(a)]; see also Section 301(d) of the Act [21 U.S.C. § 331(d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate 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 Allergy/Energy Combo, Natural Antibiotic (LDM), Pain Relief, Anti-Yeast, Heart Tonic x, Lung & Respiratory, Concentration Aid, Liver/Gallbladder, Hormone Health, Nerve and Stress, Ear Oil, Calendula Salve, Chickweed Salve, and Congestion Salve 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 your products safely for their intended purposes. Accordingly, Allergy/Energy Combo, Natural Antibiotic (LDM), Pain Relief, Anti-Yeast, Heart Tonic x, Lung & Respiratory, Concentration Aid, Liver/Gallbladder, Hormone Health, Nerve and Stress, Ear Oil, Calendula Salve, Chickweed Salve, and Congestion Salve 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)]. 
 
We have reviewed your response; however, we are unable to evaluate the sufficiency of your corrective actions, in that it does not address the claims within your mail order catalog. Your response provides a list of products of which your firm plans to change the names but does not provide examples of the actual labeling.
 
We advise you to review your mail order catalog, product labels, and any other labeling for your products to ensure that the products you offer for sale and the claims you make for your products do not cause them to violate the Act.
 
Adulterated Dietary Supplements
 
If your products did not have therapeutic claims which make them unapproved new drugs and/or misbranded drugs, and if the products were properly labeled as dietary supplements, certain of your products[1] would be adulterated dietary supplements within the meaning of Section 402(g)(1) of the Act [21 U.S.C § 342(g)(1)] because the products have been manufactured, packaged, labeled, and/or held under conditions that do not meet the Current Good Manufacturing Practice (CGMP) regulations for Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR 111).
 
During the inspection of your facility, the following significant violations of these CGMP requirements were observed:
 
1.    Your firm failed to establish specifications for any point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(a). Specifically, you have not established any specifications to ensure the quality of your finished products. In establishing the required specifications, you must establish:
  • Specifications for each component that you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b); 
  • Specifications for the dietary supplement labels (label specifications) and for packaging that may come in contact with the dietary supplements (packaging specifications), as required by 21 CFR 111.70(d);
  • Product specifications for the identity, purity, strength, and composition of 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, as required by 21 CFR 111.70(e);
  • Specifications for the packaging and labeling of the finished packaged and labeled dietary supplements, including specifications that ensure that you used the specified packaging and that you applied the specified label, as required by 21 CFR 111.70(g).
We have reviewed your firm’s undated response to this observation, which we received on November 27, 2017; however, your response does not identify the specific corrective actions you plan to take.  The Agency would recommend you review 21 CFR 111, specifically, Subpart E, Requirements to Establish a Production and Process Control System.
 
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. Specifically, you have no written procedures for quality control operations for the manufacturing of your dietary supplement products. You must implement quality control operations into your manufacturing, packaging, labeling, and holding operations of producing dietary supplements, as required by 21 CFR 111.65. Once you have established the required written procedures, your quality control personnel must ensure that your manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplements and that the dietary supplements are packaged and labeled as specified in the master manufacturing records, as required by 21 CFR 111.105.
 
We have reviewed your firm’s undated response to this observation, which we received November 27, 2017; however, your response does not identify the specific corrective actions you plan to take. The Agency recommends that you review 21 CFR 111, specifically, Subpart E, Requirement to Establish a Production and Process Control System, and Subpart F, Production and Process Control System, Requirements for Quality Control.
 
3.    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 by 21 CFR 111.205(a). Specifically, you do not have a written MMR for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch. You must prepare and follow an MMR that identifies specifications for the points, steps, or stages 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 MMR, as required by 21 CFR 111.205(b)(1). In establishing your written MMR, also note that  your MMR must satisfy the requirements of 21 CFR 111.210.
 
We have reviewed your firm’s undated response to this observation, which we received November 27, 2017; however, your response does not identify the specific corrective actions you plan to take. The Agency recommends you review 21 CFR 111, specifically, Subpart H, Production and Process Control System: Requirements for the Master Manufacturing Record.
 
4.    You failed to prepare a batch production record every time you manufacture a batch of your dietary supplement products, as required by 21 CFR 111.255(a). Specially, you do not prepare batch production records for any of the dietary supplements you manufacture.
 
We have reviewed your firm’s undated response to this observation, which we received November 27, 2017; however, your response does not identify the specific corrective actions you plan to take.  The Agency would recommend you review 21 CFR 111, specifically, Subpart I, Production and Process Control System: Requirements for the Batch Production Record.
 
5.    You failed to establish and follow written procedures to fulfill the requirements related to product complaints, as required by 21 CFR 111.553. Specifically, you have not established any written procedures for product complaints. In establishing your written procedures, you must ensure a qualified person performs all the required steps under 21 CFR 111.560, and you must make and keep a written record of every product complaint, as required by 21 CFR 111.570. 
 
We have reviewed your firm’s undated response to this observation, which we received November 27, 2017; however, your response does not identify the specific corrective actions you plan to take. The Agency would recommend you review 21 CFR 111, specifically, Subpart O, Product Complaints.
 
6.    You failed to establish and follow written procedures for holding and distribution operations, as required by 21 CFR 111.453. Specifically, your firm has not established written procedures for holding and distributing operations.
 
We have reviewed your firm’s undated response to this observation, which we received November 27, 2017; however, your response does not identify the specific corrective actions you plan to take. The Agency would recommend you review 21 CFR 111, specifically, Subpart M, Holding and Distributing.
 
7.    You failed to collect and hold reserve samples of reach lot of packaged and labeled dietary supplement that you distribute, as required by 21 CFR 111.83(a). Specifically, your firm does not retain samples of the products you distribute.
 
We have reviewed your firm’s undated response to this observation, which we received November 27, 2017; however, your response does not identify the specific corrective actions you plan to take. The Agency recommends that you review 21 CFR 111, specifically, Subpart E, Requirements to Establish a Production and Process Control System, in particular 21 CFR 111.83, “What are the requirements for reserve samples?”
 
 
8.    You failed to establish and follow written procedures to fulfill the requirements related to returned dietary supplement, as required by 21 CFR 111.503. Specifically, your firm does not have written procedures regarding the handling of returned dietary supplements.
 
We have reviewed your firm’s undated response to this observation, which we received November 27, 2017; however, your response does not identify the specific corrective actions you plan to take. The Agency would recommend you review 21 CFR 111, specifically, Subpart N, Returned Dietary Supplements.
 
 
Misbranded Dietary Supplements
 
If your products did not have therapeutic claims which make them unapproved new drugs and/or misbranded drugs, and if the products were properly labeled as dietary supplements, certain products of yours 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. Examples of these violations are as follows:
 
1.    Your Harmony, Varicose Relief, Yeast Rid, Joint Support, Sinus & Hayfever, Pain Relief, Heart Tonic, Cough Syrup, Dental Formula, Insure Herbal, Natural Calcium, Lung & Respiratory, Baby Calm, Varicose Relief liquid, Liver-Gallbladder, Billbright Formula, Gripe Water, Bowel Cleanser, Children’s Bowel Tonic, Arthritis Relief, Complete Tissue Syrup, Allergy/Energy Combo, Adrenal Aid, Anti-Yeast, Birth Ease, Eldermint, After-Pain Ease, Para-Cleanse, Natural Antibiotic, Natural Iron, Nerve & Stress, Quick Cleanse, Flu and Cold Aid, Migraine Relief, Concentration Aid, M. C. Formula, Rescue Remedy, M.S. Balm, Ladies Formula, Kidney and Bladder, Hormone Health, Echinacea Goldenseal, Fertil-Aid for Women, Lactation Aid, Fertil-Aid for Men, and Diarrhea-X products are misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Specifically, your products do not list the amount of fluid ounces or ounces each product consists of followed by the metric equivalent in parentheses.
 
2.    Your Varicose Relief (capsules and liquid), Gripe Water, Sinus & Hayfever, Eldermint, Anti-Yeast, Insure Herbal, Natural Calcium, Bowel Cleanser, Hormone Health, Lactation Aid, Ladies Formula, Joint Support, and Arthritis Relief products are 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. Specifically:
  • Your Varicose Relief product labels declare the ingredient stone rt., but this is not the common or usual name for this ingredient;
  • Your Gripe Water product label declares the ingredient soda, but this is not the common or usual name for this ingredient.
  • Your Sinus & Hayfever, Eldermint, Anti-Yeast, and Insure Herbal product labels declare the ingredient Echinacea, your Natural Calcium product label declares the ingredient shavegrass, your Bowel Cleanser product label declares the ingredient turkey rhubarb, your Hormone Health, Lactation Aid, and Ladies Formula product labels declare the ingredient vitex, and your Joint Support and Arthritis Relief product labels declare the ingredient Brigham tea, but these are not the standardized common names noted in the reference Herbs of Commerce;
  • Your Adrenal Aid product label indicates this is a liquid product in that the net contents is stated as “___ fl. oz.,” but the product label fails to list the liquid ingredients.  
3.    Your dietary supplement 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 labels fail to bear the serving size in accordance with 21 CFR 101.36(b)(1)(i). The terms “serving” or “serving size” for a dietary supplement are defined in 21 CFR 101.9(b) and 101.12, Table 2, as the maximum amount recommended on the label for consumption per eating occasion. Furthermore, common household measures must be followed by the equivalent metric quantity in parentheses.
 
4.    Your Harmony, Varicose Relief capsules, Yeast Rid, Joint Support, Sinus & Hayfever, Pain Relief, Heart Tonic, Cough Syrup, Dental Formula, Insure Herbal, Natural Calcium, Lung & Respiratory, Baby Calm, Varicose Relief liquid, Liver-Gallbladder, Billbright Formula, Gripe Water, Bowel Cleanser, Children’s Bowel Tonic, Arthritis Relief, Complete Tissue Syrup, Allergy/Energy Combo, Adrenal Aid, Anti-Yeast, Birth Ease, Eldermint, After-Pain Ease, Para-Cleanse, Natural Antibiotic, Natural Iron, Nerve & Stress, Quick Cleanse, Flu and Cold Aid, Migraine Relief, Concentration Aid, M. C. Formula, Rescue Remedy, M.S. Balm, Ladies Formula, Kidney and Bladder, Hormone Health, Echinacea Goldenseal, Fertil-Aid for Women, Lactation Aid, Fertil-Aid for Men, and Diarrhea-X products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. 343 (q)(5)(F)] because the label fails to bear nutrition information (“Supplements Facts”) as required by 21 CFR 101.36.
 
5.    Your dietary supplement products are misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)] because the label fails to include a statement of identity as a “dietary supplement” as required by 21 CFR 101.3(g).
 
6.    Your dietary supplement 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 labels fail 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). For example:
  • Your Flu and Cold Aid fail to include the part of the plant from which nettle and barberry are derived;
  • Your Anti Yeast fails to include the part of the plant from which red clover, pau d’arco, cat’s claw, dandelion, nettle, burdock, Echinacea, and butcher’s broom are derived;
  • Your Heart Tonic fails to include the part of the plant from which gingko, ginger, and gotu kola are derived  
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exists 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 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 promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and/or injunction.
 
Additionally, we have the following comments:
  • A copyof 21 CFR 111, Current Good Manufacturing Practice In Manufacturing, Packaging, Labeling, Or Holding Operations For Dietary Supplements, as well as a copy of the Small Entity Compliance Guide: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements December 2010 are included with this letter for your reference.
  • (b)(3)(A)  
As a responsible official of a facility that manufactures/processes, packs, re-labels or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.
 
(b)(3)(A).
 
(b)(3)(A)
 
(b)(3)(A)
 
(b)(3)(A)
 
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations, including an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete all corrective actions 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 non-compliance 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 non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
 
Please submit your response to Paul E. Frazier, Compliance Officer, at the address of 4040 North Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions, please contact Mr. Frazier at (214) 253-5340.
 
 
Sincerely,
/S/ 
Edmundo Garcia Jr.
District Director
Program Division Director
Office of Human and Animal Food, WD3


[1] Note that not all of your products could meet the definition of “dietary supplement” even if the product labeling did not bear disease claims or even if the products were properly labeled as dietary supplements. For example, products that are not intended for ingestion, such as products that are intended to be rubbed on the body, do not meet the definition of a dietary supplement. See Section 201(ff)(2)(A)(i) of the Act. Also, any products that are represented for use as a conventional food, such as a beverage, do not qualify as dietary supplements. See Section 201(ff)(2)(B) of the Act.

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