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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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MNC Pharmaceuticals Group, Inc 23-Mar-06

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

Public Health Service
Food and Drug Administration
Philadelphia District Office

 

900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
Telephone: 215-597-4390



WARNING LETTER

06-PHI-04

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

March 23, 2006

Henry Chen, Owner
MNC Pharmaceuticals Group, Inc.
214 East Lea Boulevard
Wilmington, DE 19802

Dear Mr. Chen:

On October 27th, 28th, and 31st and November 1, 2005, an investigator from the Food and Drug Administration (FDA) conducted an inspection of your herbal and dietary supplement repacking, re-labeling, and distribution facility located at 214 East Lea Boulevard, Wilmington, Delaware. During this inspection, you provided our investigator with various labeling of your products. FDA has reviewed your labeling, including your product labels and web site at http://www.micusa.com, for the following products:

MNC® Healthy Product Garlic Odorless Garlic Oil Extract, Fa Tat Nutrition Natural Barley Grass, Healthy MNC™ Product Q10 Coenzyme, Healthy MNC™ Product Vitamin E 400 IU, MNC® Natural Brand Vitamin E 400 IU, MNC® Shark Cartilage 1000mg (100 capsule and 300 capsule bottles), MNC™ Squalene, Healthy MNC™ Product Diabetin Formula, MNC™ Calcium 500mg Plus 200 IU Vitamin D, Healthy MNC™ Product Liquid Calcium, Lancer Nutritional Products Saw Palmetto Berries, MNC® Chocolate Calcium for Children, MNC™ Chewable Animal Shape Multi-Vitamin/Mineral for Children, MNC® Natural Brand Vitamin E 400 IU, and MNC® Lamb Placenta, MNC® Sheep Placenta.

Our review of your products and promotional claims shows serious violations of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and implementing regulations on FDA's website at http://www.fda.gov.

Under sectioin 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 are drugs. The therapeutic claims on your labeling, including your web site, establish that these products are intended to be used as drugs. The marketing of these products with these claims violates the Act.

Specific examples of claims in your product labeling that promote your products as drugs are as follows:

MNC® Healthy Product Garlic Odorless Garlic Oil Extract

Product Label and Website:

  • "[P]rotects against infection. . ."

  • "It lowers blood pressure. . . is good for virtually any . . .infection."

Fa Tat Nutrition Natural Barley Grass

Product label:

  • "This food heals stomach, duodenal, and colon disorders as well as pancreatitis, and is an effective anti-inflammatory."

Healthy MNC™ Product Q10 Coenzvme

Product label and Website:

  • "Co-Q10 . . . has been used in Japan . . . as a prevention and treatment of a wide variety of cardiovascular diseases, including congestive heart failure, angina pectoris, cardiac arrhythmias, high blood pressure, and atherosclerosis . . . ."

Healthy MNC™ Product Vitamin E 400 IU

Product label:

  • "Keep [sic] Vitamin E in balance could. prevent . . .muscle degeneration, some anemias and reproductive disorders."

MNC® Shark Cartilage 1000mg

Product label:

  • "The scientific results and clinic trial has approved [sic] that shark cartilage could prevent the development of tumor-based cancer and metastasis, reduce the inflammation and pain associated with arthritis, and alleviate psoriasis."

Healthy MNC™ Product Diabetin Formula

Product label:

  • "Prevent And Cure Diabetes"

  • The name of your product, Diabetin Formula, is a disease claim because it implies that the product is for use in the cure, mitigation, treatment, or prevention of diabetes.

Website:

  • "This nutrient complex works vey [sic] well to improve the metabolism of glucose and is important for circulation and for prevention of atheroscleorosis [sic], etc."

Lancer Nutritional Products Saw Palmetto Berries

Product label:

  • "Saw Palmetto has been used as a preventive [sic] for an enlarged prostate. Studies indicate increased urine flow and reduced night-time urination after taking Saw Palmetto."


MNC® Sheep Placenta

Website:

  • "[I]mprove resistance to infection. . ."

Your products are not generally recognized as safe and effective for the above referenced conditions and, therefore, these products are also new drugs under section 201(p) of the Act [21 U.S.C. 321(p)]. New drugs may not be legally marketed in the United States without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C.355(a)]. 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.

In addition, your products MNC© Healthy Product Garlic Odorless Garlic Oil Extract, Fa Tat Nutrition Natural Barley Grass, Healthy MNC™ Product Q10 Coenzyme, Healthy MNC™ Product Vitamin E 400 IU, MNC® Shark Cartilage 1000mg (100 capsule and 300 capsule bottles); Healthy MNC™ Product Diabetin Formula, and Lancer Nutritional Products Saw Palmetto Berries are misbranded under section 502(f)(1) of the Act in that the labeling for these drugs fails to bear adequate directions for use [21 U.S.C. 352(f)(1)].

Misbranded Dietary Sunplements

Even if your products did not contain disease claims in their labeling that cause them to be drugs, they would still be misbranded as dietary supplements.

Your product Fa Tat Nutrition Natural Barley Grass is misbranded under section 403(r)(1)(A) of the Act [21 U.S.C. 343(r)(1)(A)], because the product label claims the product is high in calcium, iron, vitamin C and many minerals; however, the product doesn't meet the requirements to make those claims. The term "high" is defined by regulation to mean that the product contains 20% or more of the Recommended Daily Intake (RDI) or Daily Reference Value (DRV) for the nutrient (21 CFR 101.54(b)). According to your label, the nutrients declared are present at less than the 20% level required for making the claim.

Furthermore, your products MNC® Healthy Product Garlic Odorless Garlic Oil Extract, Fa Tat Nutrition Natural Barley Grass, Healthy MNC™ Product Q10 Coenzyme, Healthy MNC™ Product Vitamin E 400 IU, Healthy MNC™ Product Diabetin Formula, MNC® Chocolate Calcium for Children, MNC® Sheep Placenta, MNC® Lamb Placenta, MNC™ Squalene, and Healthy MNCTM Product Liquid Calcium are misbranded under sections 403(i)(1) and 403(s)(2)(B) of the Act [21 U.S.C. 343(i)(1) and 21 U.S.C. 343(s)(2)(B)] in that the labels fail to identify the products using the term dietary supplement as part of the statement of identity on the principal display panel (21 CFR 101 .3(a) and (g)).

Furthermore, your products MNC® Healthy Product Garlic Odorless Garlic Oil Extract, MNC® Chocolate Calcium for Children, Healthy MNC™ Product Q10 Coenzyme, Healthy MNC™ Product Vitamin E 400 IU, Healthy MNC™ Product Diabetin Formula, MNC® Lamb Placenta, Healthy MNC™ Product Liquid Calcium, and MNC™ Squalene are misbranded under section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that the nutrition information on their product labels does not comply with 21 CFR 101.36(e). Examples of the deviations from the requirements of 21 CFR 101.36(e) include:

  • None of the products' labels, with the exception of Healthy MNC™ Product Diabetin Formula and MNC® Lamb Placenta, enclose the nutrition information in a box using hairlines, as required by 21 CFR 101.36(e)(2).

  • None of the products, with the exception of MNC® Lamb Pacenta, include any of the bars required by 21 CFR 101.36(e)(5)-(7) to separate sections of the Supplement Facts panel.

  • Your product Healthy MNC™ Product Diabetin Formula lists both dietary ingredients with an established Reference Daily Intake (RDI) (e.g., Zinc, Magnesium, Niacin, etc.) and dietary ingredients for which FDA has not set a Daily Reference Value (DRV) or RDI (e.g., Glucomanan, Cedar Berries, Vanadium, etc.) as defined under 21 CFR 101.36(b)(2) and (b)(3), respectively. However, the label does not segregate the 21 CFR 101.36(b)(2) and (b)(3) dietary ingredients into separate sections of the supplement facts panel as required by 21 CFR 101.36(b)(3)(i). Additionally, heavy bars are required immediately after the listing of the last dietary ingredient required to be declared pursuant to 21 CFR 101.36(b)(2) and (b)(3), respectively (21 CFR 101.36(e)(6)(ii) and (iii)).

  • Your product MNC® Lamb Placenta lists both dietary ingredients with an established Reference Daily Intake (RDI) (e.g., Vitamin A, Vitamin C, Vitamin E) and dietary ingredients for which FDA has not set a Daily Reference Value (DRV) or RDI (e.g., Placenta Extract, Collagen, Ceramides, RNA/DNA) as defined under 21 CFR 101.36(b)(2) and (b)(3), respectively. However, the label does not segregate the 21 CFR 101.36(b)(2) and (b)(3) dietary ingredients into separate sections of the supplement facts panel as required by 21 CFR.

  • 101.36(b)(3)(i). Additionally,heavy bars are required immediately after the listing of the last dietary ingredient required to be declared pursuant to 21 CFR 101.36(b)(2) and (b)(3), respectively (21 CFR 101.36(e)(6)(ii) and (iii)).

Furthermore, your products MNC® Healthy Product Garlic Odorless Garlic Oil Extract, MNC™ Chewable Animal Shape Multi- vitamin/Mineral for Children, MNC™ Calcium 500mg Plus 200 IU Vitamin D, and MNC® Sheep Placenta are misbranded under section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)] because the labels state the products are "manufactured by FDA approved facility." This statement is false because FDA does not approve facilities that manufacture dietary supplements.

This letter is not intended to be an all-inclusive review of your products and their labeling a. You should review the labeling for all of your products to ensure that they comply with the applicable requirements of the Act and implementing regulations. Failure to do so may result in regulatory action without further notice, such as seizure and/or injunction.

In addition to the violations described above, FDA notes the following:

The product label for your product Healthy MNC™ Product Vitamin E 400 IU lists"Ingredients" and "Other ingredients" inside the Supplement Facts box. Under 21 CFR 101.4(g), the ingredient list on dietary supplement products must be located outside the Supplement Facts box. A source ingredient that supplies a dietary ingredient may be identified within the Supplement Facts box in accordance with 101.36(d). When a source ingredient is listed in the Supplement Facts box, you must list the remaining ingredients outside the Supplement Facts box preceded by the words "Other Ingredients" to comply with 21 CFR 101.4(g).

The product labels for your products Healthy MNC ™ Product Vitamin E 400 IU, Healthy MNC™ Product Diabetin Formula, and Healthy MNC™ Product Liquid Calcium state "pass by FDA regulated facility" or "passed by FDA regulated facility." We are concerned that these statements may mislead consumers to the extent that they imply that FDA "passed" or somehow approved the product. FDA does not approve dietary supplements, and has not passed or approved any of your products.

Please notify this office in writing within fifteen (15) working days of receipt of this letter as to the specific actions you have taken or intend to take to correct these violations and an explanation of each step taken to assure that similar violations do not recur. If corrective action cannot be completed within fifteen days, please include in your reply the reason for the delay, the time within which the corrections will be completed, and any documentation necessary to indicate correction has been achieved.

Your reply should be directed to William J. Forman, Compliance Officer, at the above address.

Sincerely,

/S/

Thomas D. Gardine
District Director
FDA Philadelphia District