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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enzymology Research Center, Inc. 18-Aug-05

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

Public Health Service
Food and Drug Administration

 

Minneapolis District Office
Central Region
212 Third Avenue South
Minneapolis, MN 55401
Telephone: (612) 758-7114
FAX: (612) 334-414




August 18, 2005

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Refer to MIN 05-20

Troy A. Aupperle
President
Enzymology Research Center, Inc.
206 West Street
Miltona, MN 56354

Dear Mr. Aupperle:

This letter is in reference to your firm's manufacturing, distribution and promotion of various products documented by our inspection conducted on May 18, 2005, at your facility located at 206 West Street; Miltona, Minnesota. This inspection was conducted to determine your firm's compliance with the Federal Food, Drug, and Cosmetic Act (the Act) and applicable implementing regulations contained within Title 21 of the Code of Federal Regulations (21 CFR).

During our inspection, we collected product labels, labeling, and other promotional materials for your Re(in)TroduceTM Intestinal Bacteria, Re(inner)GizeTM Whole Food-Vitamin-Mineral, Re(in)Force IITM Therapeutic Enzyme, Digestive Enzyme, and Protease VI Pure Proteolytic Enzymes products, which are labeled as dietary supplements. Our review shows serious violations of the Act in the labels and labeling of these products.

Under the Act, articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man are drugs [section 201(g) (1) (B) of the Act, 21 U.S.C. 321(g)(1)(B)]. Promotional materials that accompany your products in interstate commerce include a pamphlet entitled "It's Tyme for Enzymes!TM", which contains the following claims about disease treatment:

  • Re(in)Troduce™ Intestinal Bacteria:

    • "Health Challenges Addressed:

    • - Bowel irregularities (constipation to diarrhea)

    • - High cholesterol . . ."

  • Re(inner)Gize™ Whole Food-Vitamin-Mineral:

    • Health Challenges Addressed: "

    • - . . . [A]nemia . . .

    • - High blood pressure .-. ."

  • Re(in)Force II ™ Therapeutic Enzyme:

    • "Health Challenges Addressed: . . .

    • - Food or airborne allergies . . .

    • - Sickness or injuries . . ."

  • Digestive Enzyme:

    • "Health Challenges Addressed:

    • . . . [H]eartburn . . ."

Directions on the labels of some of your products reference a booklet also entitled "It's Tyme for Enzymes!TM" for additional information about using the product. The booklet can be purchased with the same order form used to purchase your enzyme products. Examples of disease prevention and treatment claims for your products in this booklet are as follows:

  • " Re(in)Force II™ Therapeutic Enzyme: "Some of the benefits include: . . .

    o Decreasing food and airborne allergies

    o Removal of Floating Immune Complexes (FIC) . . .

    o Speeds up recovery time from sickness or injuries . . .

Because of the excessive amounts of FIC's the body is unable to dispose of it fast enough, so it stores them. These may end up as plaque attached to the inside of the arteries, uric acid crystals in the joints or as allergic reactions in the tissues or lungs ."

  • Re(in)Troduce™ Intestinal Bacteria: "There are a number of benefits that go along with these friendly bacteria: . . .

o Lower cholesterol levels

o Defense against food poisoning. . ."

Furthermore, this booklet includes disease treatment claims for several ingredients of the Re(in)TroduceTM Intestinal Bacteria product, as follows:

o "Lactobacillus acidophilus DDS-1 . . .reduce[s] yeast infections. . . .

o "Bifidobacterium bifidum . . . stop[s] the formation of cancer-causing agents."

o "Lactobacillus plantarum. . . eliminates dozens of harmful pathogens such as E. coli. . . ."

o "Lactobacillus salivarius. . .Its effectiveness against pathogenic microorganisms are [sic] so powerful that symptoms of food poisoning have been relieved within 30-60 minutes after ingestion ."

o "Lactobacillus casei. . .produces an antimicrobial substance that inhibits several pathogens including C. difficile diarrhea. . . ."

o "Lactobacillus rhamnosus. . .inhibit[s] uropathogenic bacteria and therefore help[s] prevent recurrent urinary tract infections."

  • Re(inner)Gize™ Whole Food-Vitamin-Mineral. The booklet makes disease prevention and treatment claims for many ingredients of the Re(inner)GizeTM Whole Food-Vitamin-Mineral product, as follow

    • "Blue Green Algae . . .Very high in chlorophyll, . . .[an] antiseptic."

    • "Vitamin A - (palmitate) . . . Used for . . .respiratory infections. . . ."

    • "Vitamin A - (beta carotene) . . .Used to lower cholesterol levels, . . . prevent certain types of cancer and heart disease ."

    • "Vitamin B3 - (niacinamide) . . .Reduces tryglycerides [sic] and cholesterol . . .reduces migraine headaches."

    • "Vitamin B5 - (pantothenic acid) .. .Helps fight infection . . . reduces negative effects of many antibiotics, aids in wound healing, lowers cholesterol."

    • "Vitamin B6 - (pyridoxine HCL). . .helps prevent kidney stones . . . ."

    • "Vitamin B12 - (cyanocobalamin) . . .lowers heart disease. . . ."

    • "Vitamin C - (calcium ascorbate) . . .Protects against many forms of cancer, accelerates healing, lowers blood pressure and blood clots. . . ."

    • "Vitamin D - (cholecalciferol) . . .prevents colds. .. ."

    • "Vitamin E - (d-alpha tocopherol). . .prevents various forms of cancer, accelerates healing process, lowers blood pressure."

    • "Vitamin K - (phytodione) . . .prevents internal bleeding and hemorrhages."

    • "Biotin. . .alleviates eczema and dermatitis,. . . ."

    • "Choline. . .Helps control cholesterol . . .increases memory, used in treatment of Alzheimer's disease."

    • "Folic Acid . . .protects against parasites and food poisoning."

    • "Inositol. . .lowers cholesterol levels . . .prevents eczema."

    • "PABA - (para-aminobenzoic acid). . .reduces the pain of burns . . . ."

    • "Boron . . .Helps prevent osteoporosis. . . ."

    • "Calcium . . . lower risk of colon cancer,. . . ."

    • "Chromium . . .Lowers blood pressure, prevents . . .chances of diabetes ."

    • "Iron. . .promotes resistance to disease . . . ."

    • "Magnesium. . . prevents heart attacks . . . . helps prevent . . .kidney and gallstones."

    • "Manganese . . . Helps eliminate . . . osteoporosis. . . ."

    • "Molybdenum. . .Helps prevent anemia. . . ."

    • "Potassium . . . Reduces blood pressure, used in allergy treatments. . . ."

    • "Selenium. . . Helps protect against cancer, heart disease and stroke . . ."

    • "Vanadium . . . Prevents heart attacks, helps control insulin-resistant and Type II diabetes. . . ."

    • "Citrus Bioflavanoids [sic] . . .builds resistance to infection . . .heals bleeding gums."

The claims quoted above cause your products Re(in)TroduceTM Intestinal Bacteria, Re(inner)GizeTM Whole Food-Vitamin-Mineral, Re(in)Force IITM Therapeutic Enzyme, and Digestive Enzyme to be drugs, as defined in section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)]. Because these products are not generally recognized as safe and effective when used as labeled, they are also new drugs as defined in section 201(p) of the Act [21 U.S.C. 321(p)]. Under Section 505 of the Act [21 U.S.C. 355], a new drug may not be legally marketed in the United States without an approved New Drug Application (NDA). 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.

Your products Digestive Enzyme, Re(in)Force IITM Therapeutic Enzyme, and Protease VI Pure Proteolytic Enzymes, which are labeled as dietary supplements, are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that the nutrition information is not declared in the required format on their product labels as specified in 21 CFR 101.36. For example, 21 CFR 101.36(b)(2) states that minerals must be declared when they are added to the product for purposes of supplementation. The minerals must be presented in the order and manner specified by the regulation along with their amounts and, if applicable, percent Daily Value. Furthermore, the minerals must be declared before the ingredients listed as "Enzyme blend" [21 CFR 101.36(b)(3)].

We request that you take prompt action to correct these violations. Failure to promptly correct these violations may result in enforcement action being initiated by the Food and Drug Administration without further notice. The Act provides for the seizure of illegal products and/or injunction against the manufacturer and/or distributor of illegal products.

In addition to the violations described above, we have several comments on your product labels and labeling. The labels for all five of your Re(in)TroduceTM Intestinal Bacteria and Re(inner)GizeTM Whole Food products discussed in this letter contain a nutrition information panel titled "Nutrition Facts," although they are labeled as dietary supplements. Per 21 CFR 101 .36(e)(1), dietary supplement nutrition information panels must be titled "Supplement Facts."

Also, your Digestive Enzyme and Protease VI Pure Proteolytic Enzymes Dietary Supplement product labels do not declare the name and place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(d).

In addition, we also make the following observations on information in your "It's 'Iyme for Enzymes!TM" booklet:

  • " Under the "Whole Food-Vitamin-Mineral Recommendations" section, the following statement is made: "This product contains 417% of the Daily Value of Vitamin C. There was an error made on the label." You should be aware that this statement does not constitute an effective corrective action for the misbranding of the product. The product label itself must be corrected.

  • " Under the "Intestinal Bacteria Recommendations" section, the following statement is made: "This Product needs to be Refrigerated"; however, the package label does not state this requirement.

This letter is not intended to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that all labels and labeling for products distributed by your firm are in compliance with the Act and its implementing regulations. FDA regulations are available on FDA's website at wwvw.fda.gov.

Please notify this office in writing within 15 working days of receipt.of this letter of the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify and make corrections to assure that similar violations will not recur. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be implemented.

Your reply should be sent to the attention of Compliance Officer Tyra S. Wisecup at the address on the letterhead.

Sincerely,

/S/

W. Charles Becoat
Director
Minneapolis District