Inspections, Compliance, Enforcement, and Criminal Investigations
Vigor Nutriceutical Healthcare, Inc. 20-Aug-07
Department of Health and Human Services
Public Health Service
Minneapolis District Office
August 20, 2007
RETURN RECEIPT REQUESTED
Refer to MIN 07 - 20
Peter N. Choi
Vigor Nutriceutical Healthcare, Inc.
998 Kimberton Court
Sun Prairie, Wisconsin 53590-4011
Dear Mr. Choi:
This letter is in reference to your firm's distribution of various products documented by our inspection conducted November 15, 2006, and March 5, 2007, at your facility located at 998 Kimberton Court, Sun Prairie, Wisconsin. 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).
This review reveals serious violations of the Act. You can find the Act and implementing regulations through links on FDA's Internet home page at www.fda.gov.
Under Section 201(g)(1) (B) of the Act [21 U.S.C. 321(g)(1)(B)], articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man are drugs. The therapeutic claims on your product labels and in their labeling establish that these products are drugs under that definition.
Specific examples of claims on your product bottles or retail cartons that promote your products as drugs are as follows:
• Neophase™ Constipation Relief Herbal Supplement, 12 Capsules, 460 mg each: "...Gentle Elimination...Restoring Regularity..."
• Neophase™ Pepticease Fast Relief Herbal Supplement, 60 Capsules, 460 mg each: "...Stomach ulcer...Duodenal ulcer...Dyspepsia...Dnorexia [sicj...Gastritis...People with ulcer shall discontinue use for 1-3 days when abdominal pain is present after taking for 7-8 days, then continue to use for complete heal."
• Neophase™ Neckeas Fast Relief Herbal Supplement, 8 Capsules, 600 mg each: (Bottle label) " ...Only relieve the symptoms caused by sitting too long without getting up or changing positions, poor posture, improper sleeping habits..." and (Retail carton): "...Neck Pain... Numbness of Upper Extremities...Dizziness... Spinal Rigidity... Only relieve the symptoms caused by sitting too long without getting up or changing positions, poor posture, improper sleeping habits.... "
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.
Even if your products identified above were not drugs, they would still be misbranded within the meaning of section 403(i)(2): of the Act [21 U.S.C. § 343(i)(2)J, in that the labeling fails to bear the common or usual name of each ingredient in the product. Specifically, the products are labeled to contain herbs or botanicals; however the ingredients used in your products are actually dried and powdered extracts from the plant materials that are claimed on the labels and must be declared as such.
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 labeling for products distributed by your firm are in compliance with the Act and its implementing; regulations. FDA regulations are available on FDA's web site at www.fda.gov.
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.
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.
In addition, we recommend that you review the claims found on your small folded pamphlet entitled, in part, "...Neophase™... Health Products Herbal Series," in your larger booklet entitled, in part, "Neophase®...Vigor Nutriceutical Healthcare inc 100% Natural Formula," and in your product catalog entitled, in part, "Neophase™...Vigor Nutriceutical Healthcare, Inc." If these materials accompany your products, they would be considered labeling. The disease claims in these materials also serve as further evidence that these products are intended to be used as drugs.
Furthermore, the labeling on the product bottles and/or retail cartons fail to declare an accurate place of business of the manufacturer, packer, or distributor. The printed address states that the products are formulated and distributed by Vigor Nutriceutical Healthcare Inc. in Chicago, Illinois; however, your firm is not listed in the Chicago telephone directory and is actually located in Sun Prairie, Wisconsin.
Your reply should be sent to the attention of Compliance Officer Tyra S. Wisecup at the address on the letterhead.
W. Charles Becoat