Inspections, Compliance, Enforcement, and Criminal Investigations

Universal Formulas, Inc. 3/3/16

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Detroit District
300 River Place
Suite 5900
Detroit. Ml 48207
Telephone: 313-393-8100
FAX: 313-393-8139 

 

WARNING LETTER
2016-DET-08
 
 
 
March 3, 2016
 
Via UPS
 
Andrew J. Bruex, Chief Executive Officer
Universal Formulas, LLC
7136 E N Avenue
Kalamazoo, MI 49048
 
Dear Mr. Bruex:
 
On May 13, 2015, through June 1, 2015, the U.S. Food and Drug Administration (FDA) performed an inspection of your warehouse and distribution facilities located at 7136 E N Avenue, Kalamazoo, MI. During the inspection FDA collected product labeling. Additionally, FDA subsequently reviewed your websites at the Internet addresses www.universalformulas.com and www.mybepure.com. Based on our inspection and review of your product labeling, including your firm’s websites, we found serious violations of the Federal Food, Drug and Cosmetic Act (the Act) and its implementing regulations.
 
You can find the Act and FDA regulations through links on FDA’s home page at http://www.fda.gov.
 
Unapproved New Drugs
 
The FDA reviewed your websites at the Internet addresses www.universalformulas.com and www.mybepure.com in January 2016 and has determined that you take orders there for the products Quint-Essence Blend, TraciteTM Mineral Formulation, Niacin 100 mg, Natural Vitamin D3, EB-Digestive Aid, Sweet Balance, EssiaCaps, Natural Vitamin E 400 IU, HerpEx, InflamEx, ParasitEX, CandidaEX, Asthma Wellness Protocol, ALS (Lou Gehrig’s Disease) Protocol, Blood Pressure Wellness Protocol, ADD and ADHD Management Protocol, Breast Carcinoma Nutritional Support Protocol, Melanoma Nutritional Support Protocol, and Colon Carcinoma Nutritional Support Protocol. 
 
Additionally, the FDA has reviewed your product labeling for Quint-Essence Blend, TraciteTM Mineral Formulation, Niacin 100 mg, Natural Vitamin D3, EB-Digestive Aid, Sweet Balance, EssiaCaps, Natural Vitamin E 400 IU, HerpEx, InflamEx, ParasitEX, CandidaEX, Asthma Wellness Protocol, ALS (Lou Gehrig’s Disease) Protocol, Blood Pressure Wellness Protocol, ADD and ADHD Management Protocol, Breast Carcinoma Nutritional Support Protocol, Melanoma Nutritional Support Protocol, and Colon Carcinoma Nutritional Support Protocol, obtained during the May through June inspection of your facilities. 
 
The claims on your websites and other product labeling establish that the above-mentioned 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 labeling claims that provide evidence that your products are intended for use as drugs include:
 
“Quint-Essence Blend Formulation” capsules:
  • The Related Concerns tab on www.universalformulas.com contains the claims, “Psoriasis… Eczema … Inflammation... Lung Disease… Hepatitis… Arthritis, Osteoporosis, rheumatism… Inflammation – Pain… Herpes… Gout… Fibromyalgia… Macular Degeneration… Depression… Candida, Fungus and Yeast Infestations… Allergies… Anxiety Attacks… Arthritis… Colitis… Constipation… Diverticulitis… Irritable Bowel Syndrome… Cancers”
  • The www.universalformulas.com metatags, which are used to bring consumers to your website, also include claims for Quint-Essence Blend, which include, but are not limited to: “Alzheimer’s… glaucoma… impotence… mononucleosis… asthma… bed sores… benign prostatic hyperplasia… berberi… blood clot… chlamydia… cirrhosis… Flu… colitis… Conjunctivitis… Crohn's disease… Epilepsy… HPV… gonorrhea… heart disease… Hepatitis… Hyperthyroidism… neuropathy… Parkinson’s… Psoriasis… Ringworm… Trichomonas vaginalis… tuberculosis… UTI…”
“TraciteTM Mineral Formulation”
  • The Product Description tab on www.universalformulas.com contains the claim, “Reported internal beneficial use in…Reducing high blood pressure”
  • The Data Sheet tab on www.universalformulas.com contains a product flyer with the claims, “Tracite…It is rich in macro-minerals, trace minerals…some common ailments that can be related to a mineral deficiency are: Arthritis… diabetes… cardiovascular disorders… stomach ulcers… Alzheimer’s… stroke… aneurysm... anemia”
  • The www.universalformulas.com metatags for this product include, “diabetes… abscess… addiction… Alzheimer’s… anorexia nervosa… asthma… astigmatism… infection… bronchitis… candidiasis… chlamydia… cirrhosis… cystitis… emphysema… gastritis… genital warts… glaucoma… gonorrhea… herpes… hypoglycemia… inflammation… sleep disorders… irritable bowel syndrome… kidney stones… Lyme disease… osteoporosis… prostatitis…. Rheumatoid arthritis… shingles… sinusitis… stroke… syphilis… vomiting… whooping cough…fungal infection”
  • Claims on www.mybepure.com include, “Mineral Deficiencies may be related to: arthritis…diabetes…cardiovascular disorders… stomach ulcers… anemia… Alzheimer’s and dementia…stroke…aneurysm…”
“Niacin 100 mg”
  • The product label contains the claim, “Nicotinic Acid (Vitamin B-3) is a cholesterol lowering substance and protects against cardiovascular disease…. It has been reported to relieve migraine headaches, alleviate arthritis, and reduce high blood pressure.”
  • The Product Description tab on www.universalformulas.com lists the claims, “Nicotinic acid (Vitamin B-3) is a cholesterol lowering substance and protects against cardiovascular disease…reported to relieve migraine headaches, alleviate arthritis, and reduce high blood pressure…large doses of niacin (as nicotinic acid, the form of niacin in this product) are prescribed to combat high blood pressure and to broadly improve blood cholesterol levels. Niacin is used to treat dyslipidemas [sic] because of its low cost and its unique ability to improve lipid profiles…Pharmacologic doses of niacin…typically reduce LDL cholesterol levels by 10 to 25 percent and triglyceride levels by 20 to 50 percent.”
  • The Data Sheet tab on www.universalformulas.com contains a product flyer with the claims, “High doses of niacin (as nicotinic acid, as in this product) can lower cholesterol levels…The primary cardiovascular measures such as cholesterol and triglyceride levels, strokes and heart attacks are all significantly reduced with niacin therapy….”
  • Claims in your product catalog, available for download from www.universalformulas.com, include, “Nicotinic acid (Vitamin B-3) is a cholesterol lowering substance and protects against cardiovascular disease…reported to relieve migraine headaches, alleviate arthritis, and reduce high blood pressure…”
  • The www.universalformulas.com metatags for this product include, “mental health disorders… multiple sclerosis… neuralgia… pancreatitis… asthma… benign prostatic hyperplasia… blood clots… cirrhosis… convulsions… depression… high blood pressure… hypoglycemia”
“Natural Vitamin D3”
  • The product label contains the claim, “...recent research has discovered Vitamin D3’s expanding roles in inflammation, pain, heart-disease, and cancers.”
  • The Product Description tab on www.universalformulas.com lists the claims, “Recent research has discovered Vitamin D’s expanding roles in inflammation, pain, heart disease, cancers and more. Specifically, Vitamin D was recently discovered to inhibit inflammation…”
  • The Data Sheet tab on www.universalformulas.com contains a product flyer that lists the claims, “Vitamin D3 deficiency is linked to a surprising number of other health conditions such as depression, back pain, bone weakness, rheumatoid arthritis, cancer…and pre-eclampsia during pregnancy…and macular degeneration.”
  • Claims in your product catalog, available for download from www.universalformulas.com: “Recent research has discovered Vitamin D’s expanding roles in inflammation, pain, heart disease, cancers and more. Specifically, Vitamin D was recently discovered to inhibit inflammation by inhibiting proteins linked to tumors.”
  • The www.universalformulas.com metatags for this product include, “anorexia nervosa… arthritis… bed sores… chlamydia… flu… conjunctivitis… pink eye… genital warts… HPV… mononucleosis… multiple sclerosis… rheumatoid arthritis… syphilis… tuberculosis…viral infection…” 
“EB-Digestive Aid”
  • The Related Concerns tab on www.universalformulas.com lists the claims, “psoriasis… eczema… parasites… arthritis, osteoporosis, rheumatism… herpes… fibromyalgia… diabetes… cysts… cholesterol… heart disease – atherosclerosis… acid reflux – heartburn… allergies… Crohn's… Colitis… diarrhea… diverticulitis… cancers”
  • The Data Sheet tab on www.universalformulas.com contains a product flyer with the claims,“[the ingredient Bromelain] has been shown to reduce inflammation”
  • The www.universalformulas.com metatags for this product include, “pancreatitis… prostatitis… tendonitis… abscess… add… adhd… blood clots… bronchitis… carpel tunnel… diabetes… dysentery… food poisoning… gallstones… irritable bowel syndrome… kidney stones…lupus”
“Sweet Balance”
  • The product label contains the claims, “Natural Blood Glucose Control” and “Sweet Balance is a combination of herbs, minerals, and enzymes designed to assist with hyperglycemic concerns, such as diabetes…Sweet Balance was designed for both Type I and Type II diabetics.”
  • The Product Description tab on www.universalformulas.com lists the claim, “Sweet Balance is a combination of herbs, minerals, and enzymes designed to assist with hyper-glycemic concerns, such as diabetes”
  • The Data Sheet tab on www.universalformulas.com contains a product flyer with the claims, “It contains herbs that will assist beta cells and balance the production of insulin…Sweet Balance was designed as a primary protocol for Type I diabetics and as a follow-up for Type II diabetics…Ingredients included in Sweet Balance... Cedar Berries have showing some evidence of helping the body produce it’s [sic] own insulin…Banaba Leaf – according to preliminary research, this herb seems to lower blood glucose in people with type 2 diabetes…Pau D’arco Bark is used to treat infection, inflammation and anemia….”
  • The www.universalformulas.com metatags: “diabetes… low blood sugar”
“EssiaCaps – the Original Formula in Capsules”
  • The Product Description tab on www.universalformulas.com lists the claims, “Uses based on tradition or theory… AIDS/HIV…arthritis, asthma…chronic fatigue syndrome… diabetes… head/neck cancers, Hodgkin’s disease… kidney diseases, leukemia… Lyme disease, lymphoma, multiple myeloma, non-Hodgkin’s lymphoma… paralysis… systemic lupus erythematosus, thyroid disorders.”
  • The Data Sheet tab on www.universalformulas.com contains a product flyer with the claim, “Essiac (es-ee-ack) is an herbal tea remedy attributed to Nurse Rene M Caisse… Rene successfully treated cancer patients with her Essiac remedy.”
  • The www.universalformulas.com metatags for this product include, “cancer… heartburn… acid-reflux… asthma… bed sores… colitis… crohn's disease… diarrhea… diverticulosis… diverticulitis… emphysema”
“Natural Vitamin E 400 IU”
  • The Product Description tab on www.universalformulas.com and the flyer found on the data sheet tab list the claims: “Vitamin E (alpha tocopherol) is an anti-oxidant that is important in the prevention of cardiovascular disease and several types of cancer…uses include treating cardiac autonomic neuropathy (a complication of diabetes), low sperm count, restless leg syndrome, and inflammation of eye tissues, Parkinson’s and rheumatoid arthritis.”
  • The Product Description tab on www.universalformulas.com lists the testimonial, “My patient had surgery…after the surgery he developed blood clots…I advised him to take the Universal Vitamin E Formula…he asked his doctor about that and was told not to do it because, ‘it could dislodge a clot and cause a stroke’…he bought several bottles of Universal E and started taking 10 every day…by the end of the first week he was back to work and by the end of the second week all of his symptoms had completely resolved.”
  • The Related Concerns tab on www.universalformulas.com lists the claims, “Psoriasis… eczema… lung disease… arthritis, osteoporosis, rheumatism… heart disease… diabetes… depression… cysts… cardio vascular issues – blood pressure… heartburn… allergies… arthritis… Crohn's… colitis… diverticulitis”
“HerpEX”
  • The name of the product is an implied disease claim for herpes.
  • The label also contains directions that imply treatment for a medical condition, such as “As needed dosage: based on need or severity. Take the following dosages based on condition…Flare-Up: Take 3 servings between meals (9/Day)”
“InflamEx”
  • The name of the product is an implied disease claim for inflammation.
  • The label also contains the statements, “Natural Approach to Inflammation Management Providing Maximum Relief” and “Take this product as needed for inflammation management.”
“ParasitEx”
  • The name of the product is an implied disease claim for parasite infection.
  • The label contains the claim, “Superior Parasite Elimination Optimized to Maximize Results.”
“CandidaEX”
  • The name of the product an implied disease claim for candida infection.
  • The label includes the claim, “Candida Cleanse in an Optimized Formula to Provide Maximum Results.”
 “Breast Carcinoma Nutritional Support Protocol”
  • The name of the product is a disease claim. 
  • The Data Sheet tab on www.universalformulas.com contains a promotional flyer that includes claims such as, “If you are undergoing chemotherapy, surgery, radiation, or have elected not to seek the conventional medical treatment it is our intention to support your choice with nutritional support…By supporting your nutritional needs….you increase your chances of survival while easing the side effects of chemotherapy, radiation, drug therapy, and/or surgery.”
  • The www.universalformulas.com metatags for this product include, “cancer…breast…carcinoma.”
“Melanoma Nutritional Support Protocol”
  • The name of the product is a disease claim.  
  • Further, the Data Sheet tab on www.universalformulas.com contains a promotional flyer that includes claims such as, “If you are undergoing chemotherapy, surgery, radiation, or have elected not to seek the conventional medical treatment it is our intention to support your choice with nutritional support…By supporting your nutritional needs….you increase your chances of survival while easing the side effects of chemotherapy, radiation, drug therapy, and/or surgery.”
  • The www.universalformulas.com metatags for this product include, “cancer…melanoma.”
“Colon Carcinoma Nutritional Support Protocol”
  • The name of the product is a disease claim.  
  • Further, the Data Sheet tab on www.universalformulas.com contains a promotional flyer that includes claims such as, “If you are undergoing chemotherapy, surgery, radiation, or have elected not to seek the conventional medical treatment it is our intention to support your choice with nutritional support…By supporting your nutritional needs…you increase your chances of survival while easing the side effects of chemotherapy, radiation, drug therapy, and/or surgery.”
  • The www.universalformulas.com metatags for this product include, “cancer...colon…carcinoma.”
“Asthma Wellness Protocol” 
  • The name of the product is a disease claim. 
  • The Product Description tab for this product contains claims such as “[one of the products in the kit] InflamEX eases inflammation of the air passage linings that occurs when muscles surrounding the airways become tight during an asthma attack.”
  • The promotional flyer found on the www.universalformulas.com Data Sheet tab states, “InflamEX #6247 – An herbal combination formulated to help keep inflammation at minimum of the small tubes that transport air to the lungs may cause an asthma attack” [sic].
  • The product catalog contains claims for this protocol such as, “to reduce inflammation” and “anti-inflammatory.”
“Blood Pressure Wellness Protocol”
  • The name of the product is a disease claim.
  • The Product Description tab and the product catalog on www.universalformulas.com include the claim, “This Wellness Protocol brings…supplementation program in order to lower an individual’s BP to a healthy rate.”
  • The promotional flyer found on the www.universalformulas.com Data Sheet tab contains claims such as “Herbs such as [an ingredient in Brilliance, one of the products in the kit] Gotu-Kola were traditionally used in India as an herbal remedy for blood pressure problems.”
  • The www.universalformulas.com metatags for this product include, “high blood pressure.”
ALS (Lou Gehrig’s Disease) Protocol
  • The name of the product is a disease claim. 
  • The Product Description tab on www.universalformulas.com includes claims such as, “This Wellness Protocol brings together the traditional herbs and minerals of our individual formulations to replenish vitality and increase nutritional value at a cellular level through a simplified, consistent and balances supplementation program in order to reduce the symptoms associated with ALS.”
  • The product catalog contains claims such as, “This protocol contains herbs formulated to relax mind and muscles to alleviate symptoms of ALS.”
  • This product’s www.universalformulas.com metatags include “berberi [sic]…ALS...”
ADD and ADHD Management Protocol
  • The name of the product is a disease claim. 
  • The Product Description tab on www.universalformulas.com includes claims such as, “This Wellness Protocol brings together the traditional herbs, vitamins and minerals of our individual formulations to reduce the symptoms of ADD and ADHD...” 
  • The www.universalformulas.com metatags for this protocol on include, “add…adhd…attention hyper deficient disorder child kid”
Your 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 Quint-Essence Blend, TraciteTM Mineral Formulation, Niacin 100 mg, Natural Vitamin D3, EB-Digestive Aid, Sweet Balance, EssiaCaps, Natural Vitamin E 400 IU, HerpEx, , Asthma Wellness Protocol, ALS (Lou Gehrig’s Disease) Protocol, Blood Pressure Wellness Protocol, ADD and ADHD Management Protocol 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, your Quint-Essence Blend, TraciteTM Mineral Formulation, Niacin 100 mg, Natural Vitamin D3, EB-Digestive Aid, Sweet Balance, EssiaCaps, Natural Vitamin E 400 IU, HerpEx, Asthma Wellness Protocol, ALS (Lou Gehrig’s Disease) Protocol, Blood Pressure Wellness Protocol, ADD and ADHD Management Protocol 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)].
 
Adulterated Dietary Supplements
 
Even if your Quint-Essence Blend, TraciteTM Mineral Formulation, Niacin 100 mg, Natural Vitamin D3, EB-Digestive Aid, Sweet Balance, EssiaCaps, Natural Vitamin E 400 IU, HerpEx, InflamEx, ParasitEX, CandidaEX products did not have disease claims which make them unapproved new drugs, the products and any other dietary supplement products that you manufacture 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 prepared, packed, or held under conditions that do not meet the current good manufacturing practice (cGMP) regulations for dietary supplements in Title 21 of the Code of Federal Regulations, Part 111 (21 CFR Part 111).
 
Significant violations documented during the inspection include the following:
 
1.    You failed to establish product specifications for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e). Additionally, you must verify that your finished batch of the dietary supplement meets product specifications for identity, purity, strength, composition, and limits on contamination, as required by 21 CFR 111.75(c). Specifically, your product specifications do not include limits for potential contaminants such as microorganisms, heavy metals and/or pesticides.
 
We have reviewed your June 18, 2015 response. Your response included a copy of the procedure UF-019-SOP Specifications, which lists a purpose of providing guidelines for the development of specifications. The SOP lists criteria that appear to be applicable to operations who manufacture dietary supplements from raw materials, such as testing of raw materials. Your facility does not manufacture dietary supplements from raw materials. Because this response did not include any specifications for our review, we cannot verify the adequacy of the response.   
 
2.    You failed to establish specifications for the labels of the dietary supplements that you distribute under your firm’s name, as required by 21 CFR 111.70(d). Specifically, during the inspection, you stated that the template labels you use do not contain any dimensions, text requirements, or any other labeling elements to ensure the label applied to the dietary supplement product contains all of the required information and is in the correct format. Additionally, you failed to establish specifications for the labeling operations you conduct for finished packaged and labeled dietary supplements, including specifications to ensure that you applied the specified label, as required by 21 CFR 111.70(g).
 
Your June 18, 2015 response included a copy of the procedure UF-019-SOP Specifications, which lists a purpose of providing guidelines for the development of specifications. The SOP lists criteria that appear to be applicable to operations who manufacture dietary supplements from raw materials, such as testing of raw materials. Your facility does not manufacture dietary supplements from raw materials.  Further, your July 3, 2015 and October 1, 2015 responses refer to several SOP’s (i.e. UF-024-SOP: Quality Assurance - Quality Control Operations, UF-029-SOP: Contract Manufacturers/Laboratories, and UF-032-SOP: Packaging and Labeling Operations) but does not provide any established specifications for our review about specifications for the labels of your dietary supplement products manufactured by contract manufacturers; therefore, we are unable to assess the adequacy of your response.
 
3.    You did not 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). Packaging and labeling are considered manufacturing operations; therefore, you must prepare and follow a written MMR that covers the packaging and labeling operations of your firm. Specifically, your firm does not have a master manufacturing record covering the packaging and labeling for any of the products you distribute, including: Quint-Essence Blend, TraciteTM Mineral Formulation, Niacin 100 mg, Natural Vitamin D3, EB-Digestive Aid, Sweet Balance, EssiaCaps, Natural Vitamin E 400 I.U, InflamEX, ParasitEX, and HerpEX.  
 
Your June 18, 2015, July 3, 2015 and October 1, 2015 responses include a copy of, and/or references to, UF-026-SOP Master Manufacturing Records. The SOP appears to include elements that do not pertain to your operation, such as details regarding adding raw materials. Because this response did not include a written MMR for our review, we cannot verify the adequacy of the response. 
 
4.    You failed to prepare a batch production record every time you manufacture a batch of dietary supplements, as required by 21 CFR 111.255(a).  Specifically, you currently label several different products received from your contract manufactures to be sold under your own label; however, you were unable to provide batch production records for the packaging and labeling of any of these products. These products include, but are not limited to: Quint-Essence Blend, TraciteTM Mineral Formulation, Sweet Balance, InflamEX, ParasitEX, HerpEX, and EssiaCaps. 
 
Your June 18, 2015, July 3, 2015 and October 1, 2015 responses include a copy of and/or reference to UF-027-SOP Batch Production Records, which appears to include elements that do not pertain to your operation, such as details regarding adding raw materials to the batches of dietary supplements. Further, you have not provided copies of executed batch records for your labeling operations or other evidence to demonstrate your SOP has been implemented; therefore, we are unable to assess the adequacy of your response.
 
5.    You failed to control the issuance and use of packaging and labels, and reconciliation of any issuance and use discrepancies, as required by 21 CFR 111.410(b). Specifically, during the inspection you were unable to provide a record or log that tracks how many labels are issued, used, and left over at the end of the labeling operation.
 
We have reviewed your June 18, 2015, July 3, 2015 and October 1, 2015 responses; however, because you have not provided evidence to support that you are reconciling labels issued to your current labeling operations we are unable to assess the adequacy of your response.
 
6.    Your firm failed to retain samples for 1 year past the shelf life date (if shelf life dating is used), or for 2 years from the date of distribution of the last batch of dietary supplements associated with the reserve samples, for use in appropriate investigations, as required by 21 CFR 111.465(b). Specifically, during the inspection you confirmed that reserve samples for each received batch of product are only held while the lot of product remains in your inventory.
 
We have reviewed your June 18, 2015, July 3, 2015 and October 1, 2015 responses; however, because you have not provided evidence that you have implemented record-keeping of the reserve samples currently held for recent lots of product we are unable to assess the adequacy of your response.
 
7.    You failed to establish specifications for products received from a supplier for packaging or labeling, as a dietary supplement (and for distribution rather than for return to the supplier) 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). Specifically, you do not have written specifications to assure the identity of a finished dietary supplement product received prior to labeling. 
 
We note that, to the extent you contract with other manufacturers to manufacture, package, or label dietary supplements that your firm releases for distribution, you have an obligation to know what and how manufacturing activities are performed so that you can make decisions related to whether your packaged and labeled dietary supplement products conform to established specifications and whether to approve and release the products for distribution [See 72 Fed. Reg. 34752, 34790 (June 25, 2007)]. 
 
We have reviewed your June 18, 2015, July 3, 2015 and October 1, 2015 responses; however, because you have not provided evidence that you have established and implemented specifications to assure the identity of a finished dietary supplement product received prior to labeling we are unable to assess the adequacy of your response.
 
Misbranded Dietary Supplements
 
Even if your Quint-Essence Blend, TraciteTM Mineral Formulation, Niacin 100 mg, Natural Vitamin D3, EB-Digestive Aid, Sweet Balance, EssiaCaps, Natural Vitamin E 400 IU, HerpEx, InflamEx, ParasitEX, and CandidaEX products were not unapproved new drugs, they would still be misbranded dietary supplements under section 403 of the Act [21 U.S.C. § 343], as are your Bepure evening, Bepure afternoon, and Bepure morning products, based on violations of the labeling requirements for dietary supplements and other foods, which are found in 21 CFR Part 101.  Your label violations include the following:
 
1.    Your Sweet Balance, InflamEX, ParasitEX, and CandidaEX product labels are misbranded within the meaning of Section 403(s)(2)(C) of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. 343(s)(2)(C)] because the label fails to identify the part of the plant from which some of the dietary ingredients are derived in accordance with 21 CFR 101.4(h)(1). For example:
 
a.    Your Sweet Balance product label declares the dietary ingredients Gymnema syvestre 25% PE, Pau D’Arco 4:1 PE, and Reishi mushroom 10% PE, but fails to identify the part of the plant used to derive these botanical ingredients.
 
b.    Your InflamEx product label declares the dietary ingredients Boswellia, Turmeric, Feverfew, Queen of Meadow, Skullcap, Coptis Chinesis, and Borage Herb but fails to identify the part of the plant used to derive these botanical ingredients.
 
c.    Your ParasitEX product label declares the dietary ingredients Wormwood Herb, Garlic, Pau D’Arco Herb, Coptis Chinesis, and Quassia but fails to identify the part of the plant used to derive these botanical ingredients.
 
d.    Your CandidaEX product label declares the dietary ingredients Coptis Chinesis and Quassia Herb but fails to identify the part of the plant used to derive these botanical ingredients.
 
e.    Your HerpEx product label declares the ingredient Wolf Berry but fails to identify the part of the plant used to derive this botanical ingredient.
 
2.    Your Vitamin D3, Niacin, Sweet Balance, EssiaCaps, TraciteTM Mineral Formulation, EB-Digestive Aid, Quint-Essence, Vitamin E 400 IU, HerpEx, InflamEx, ParasitEX, CandidaEX, Bepure evening, Bepure afternoon, and Bepure morning product labels are misbranded within the meaning of Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the labels fail to specify the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5(a).
 
3.    Your Vitamin D3, TraciteTM Mineral Formulation, and CandidaEX product labels are misbranded under Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the presentation of nutrition information does not comply with 21 CFR 101.36. Specifically:
 
a.    Your TraciteTM Mineral Formulation product label fails to declare the quantitative amount of any minerals. When a claim about these nutrients is made, the amount of the nutrient present in a serving of the product must be declared, as well as the percentage of the daily value, as required by 21 CFR 101.36(b)(2)(i). Your label claims that the TraciteTM Mineral Formulation product is “It is naturally high in fulvic trace minerals and elements. Contains over 70 Essential and Elemental Fulvic Trace Minerals.” This claim characterizes the levels of nutrients of the type required to be in nutrition labeling in your products. The name of the nutrient, its quantitative amount by weight per serving, as well as the percentage of the daily value must be declared when they are added to the product for purposes of supplementation or when a claim is made about them, in accordance with 21 CFR 101.36(b)(2)(i);
 
b.    Your Bepure morning, Bepure afternoon, Bepure evening, products fail to bear nutrition information (a “Supplement Facts” panel) in accordance with 21 CFR 101.36 and they are not exempt from this requirement;
 
c.    Your Vitamin E 400 IU product label indicates a quantitative amount and % Daily Value listed for vitamin E in addition to what appears to be a source listing which includes beta, gamma and delta tocopherols. We emphasize that the Reference Daily Intake, and thus the Daily Value, for vitamin E is based solely on alpha-tocopherol. The listing of other, non-alpha, tocopherol ingredients should be listed in accordance with 21 CFR 101.36(b)(3);
 
d.    Your HerpEx product label fails to bear the % Daily Value for the dietary ingredient Zinc;
 
e.    Your Quint-Essence product lists ingredients such as calcium ascorbate, calcium citrate, manganese citrate and potassium citrate. Each of these ingredients appears to be the source ingredient for the nutrients calcium or manganese. Furthermore, the listing of a specific nutrient is for the nutrient and not for the source of the nutrient.
 
4.    Your Sweet Balance Herbal Formulation, EssiaCaps, TraciteTM Mineral Formulation, Quint-Essence, HerpEx, ParasitEX, CandidaEX, InflamEx, Bepure morning, Bepure afternoon, and Bepure evening products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because they fail to declare the common or usual name of each ingredient in accordance with 21 CFR 101.4(a)(1), 21 CFR 101.4(b), 21 CFR 101.4(g) and 21 CFR 101.36(c)(1). Specifically:
 
a.    Your Bepure evening, Bepure afternoon, and Bepure morning product labels fail to list any dietary ingredients or other ingredients;
 
b.    Your Sweet Balance, EssiaCaps, TraciteTM Mineral Formulation, EB-Digestive Aid, and Quint-Essence product labels list the dietary ingredient, “Tracite,” which is not the common or usual name of any food ingredient;
 
c.    Your HerpEx, EB-Digestive Aid, Quint-Essence, and Sweet Balance product labels list: UF Food Enzyme Complex”, “Super Lacto Probiotic Blend”, “Proprietary Blend of 44 Greens”, and “food enzyme blend”, respectively, but fail to list the common or usual name of each dietary ingredient contained in the blend;
 
d.    Your CandidaEX label lists “TraciteTM Fulvic Trace Mineral Complex** (Proprietary Blend of 77 Fulvic trace minerals),” but fails to list the common or usual name of each dietary ingredient contained in the blend;
 
e.    Your Sweet Balance product label list the dietary ingredient, “Banaba” and “Cedar Berry” each of which is not the standardized common name or Latin binomial name;
 
f.     Your HerpEx product label fails to list the standardized common name and/or Latin binomial name for the dietary ingredient Wolf Berry;
 
g.    Your CandidaEX product label incorrectly lists several bacteria; the complete Latin binomial name, including the genus should be indicated;
 
h.    Your EssiaCaps label lists the ingredient “Vegetarian Capsule” in the other ingredients list, but fails to list the capsule ingredients;
 
i.      Your HerpEx, ParasitEX, CandidaEX, Quint-Essence, Sweet Balance, and InflamEx product labels list the ingredient “Vegi-Capsules” in the other ingredients list, but fail to list the capsule ingredients.
 
5.    Your EssiaCaps, InflamEX, CandidaEX, and TraciteTM Mineral Formulation products are misbranded under Section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] in that the serving size listed on the product label is incorrect in accordance with 21 CFR 101.12(b). For example:
 
a.    The serving size in the EssiaCaps Supplement Facts panel is one capsule, but the directions for use indicate to take 1 to 3 capsules daily, preferrably [sic] 30 minutes before meals;”
 
b.    The serving size in the TraciteTM Mineral Formulation is “5 Drops,” but the directions for use state, “Take 5-10 drops diluted in 8 ounces of water or juice once daily. . .;”
 
c.    Your InflamEx label lists a serving size of “3 Vegi-Caps” but the directions for use list a serving size of up to “4 Caps” for some who is 210 + lbs.;
 
d.    Your CandidaEX lists a serving size of “2 Vegi-Caps,” but the directions for use list a serving size of up to “3 Caps” based on a consumer’s body weight in lbs.
 
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. Please also note that the servings per container on the principle display panel must correspond to the appropriate servings per container, given the correct serving size and the total volume or number of units in the container.
 
6.    Your Quint-Essence Blend, TraciteTM Mineral Formulation, Niacin 100 mg, Natural Vitamin D3, EB-Digestive Aid, Sweet Balance, EssiaCaps, Natural Vitamin E 400 I.U, Bepure morning, Bepure afternoon, Bepure evening, HerpEx, InflamEx, ParasitEX, and CandidaEX products are misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)] because the labels fail to include a domestic address or domestic phone number through which the responsible person (as described in section 761(b) of the Act [21 U.S.C §379AA-1]) may receive a report of a serious adverse event with such dietary supplement.
 
7.    Your Vitamin D3 and TraciteTM product labels are misbranded within the meaning of section 403(q)(1)(B) of the Act [21 U.S.C. §343(q)(1)B)] because they fail to declare the servings per container in accordance with 21 CFR 101.36(b)(1)(ii).  Specifically:
 
a.    Your Vitamin D3 product label lists a serving size of “1 Softgel” with the number of “Servings Per Container: 90”. Conversely, the net quantity of contents statement on the product’s principle display panel declares “120 Soft-Gel Pearls.” (21 CFR 101.36(b)(1)(ii));
 
b.    The number of servings in your TraciteTM product label appears to be incorrect considering the net contents (2 fluid ounces) of the product and the serving size (5 drops).
 
8.    Your Quint-Essence Blend and CandidaEX products are misbranded within the meaning of section 403(s)(2)(A) of the Act [21 U.S.C. §343(s)(2)(A)] in that the labels fail to list the name of each ingredient of the supplement that is described in section 201(ff) and the quantity of each such ingredient. Specifically:
 
a.    Your Quint-Essence Blend product labeling contains ingredient information to suggest that your product contains calcium and potassium. You do not list these dietary ingredients and you do not list the quantitative amount by weight per serving in the Supplement Facts panel in accordance with 21 CFR 101.36(b)(2);
 
b.    Your CandidaEX label fails to list the quantitative amount of the proprietary blend “TraciteTM Fulvic Trace Mineral Complex** (Proprietary Blend of 77 Fulvic trace minerals)” as required by 21 CFR 101.36(c)(3).
 
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. It is your responsibility to ensure 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/or injunction.
 
We also note the following:
  • Your Quint-Essence Blend product label lists “Vandium” as an ingredient. If your intent was to list the dietary ingredient Vanadium, the word is misspelled. Additionally, your Sweet Balance product label lists “Ophiopogan” as an ingredient. If your intent was to list the dietary ingredient Ophiopogon, the word is misspelled. Finally, your HerpEx product label inlcudes the word “ammino acid.”   If your intent was to list “amino acid,” the word is misspelled.
  • Your TraciteTM Mineral Formulation product is labeled as a dietary supplement, but is also marketed for topical use. Topical uses for which you market Tracite include treatment of open wounds, burns, killing pathogens responsible for athlete’s foot, and acting as a wide spectrum anti-microbial and fungicide. Under section 201(ff)(2)(A)(i) of the Act [21 U.S.C. § 321(ff)(2)(A)(i)], a dietary supplement is defined, among other things, as a product intended for ingestion. To the extent that your TraciteTM Mineral Formulation product is intended for a delivery method other than ingestion the product is  not a dietary supplement and may not be marketed as such.
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 re-inspection 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.
 
You should notify this office in writing within fifteen (15) working days from your receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step taken to prevent their recurrence. In your response, please include documentation of your corrective actions or steps towards long term corrective actions. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
 
Please submit your response to Seri Essary, Compliance Officer, at the above letterhead address. If you have any questions please contact Ms. Essary at (313) 393-8150.
 
                                                                                   
Sincerely,
/S/                                               
Art O. Czabaniuk
District Director
Detroit District Office  
 
Cc       Adam Stubbs, President

Page Last Updated: 03/17/2016
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