Department of Health and Human Services' logo Department of Health and Human Services

Public Health Service
Food and Drug Administration
Central Region
Minneapolis District

 

212 3rd Ave S
Minneapolis, MN 55401
Telephone: (612) 758-7114
FAX: (612) 334-4142

August 18, 2005
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

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

Ref. No. MIN-05-20

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 St, Miltona, MN. 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)Troduce™ Intestinal Bacteria, Re(inner)Gize™ Whole Food-Vitamin-Mineral, Re(in)Force II™ 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 United States Code [21 USC 321(g)(1)(B)]. Promotional materials that accompany your products in interstate commerce include a pamphlet entitled "It's Tyme for Enzymes!™", which contains the following claims about disease treatment:

Directions on the labels of some of your products reference a booklet also entitled "It's Tyme for Enzymes!™" 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:

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."

The claims quoted above cause your products Re(in)Troduce™ Intestinal Bacteria, Re(inner)Gize™ Whole Food-Vitamin-Mineral, Re(in)Force II™ Therapeutic Enzyme and Digestive Enzyme to be drugs, as defined in section 201(g)(1)(B) of the Act [21 USC 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 USC 321(p)]. Under Section 505 of the Act [21 USC 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 II™ 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 USC 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)Troduce™ Intestinal Bacteria and Re(inner)Gize™ 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 Tyme for Enzymes!™" booklet:

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 www.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
District Director

This page was posted on March 28, 2006.

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