Inspections, Compliance, Enforcement, and Criminal Investigations
The Sanapac Co., Inc. 10-Dec-04
Department of Health and Human Services
Public Health Service
RETURN RECEIPT REQUESTED
December 10, 2004
Darlene Doble, President
The Sanapac Co., Inc.
RR 3, Box 236, Orange Road
Dallas, Pennsylvania 18612
Dear Ms. Doble:
On October 7-8, 2004, an investigator from the Food and Drug Administration (FDA) inspected your repacking and distribution facility located at RR 3, Box 236, Orange Road, Dallas, Pennsylvania. During this inspection, you provided our investigator with labels and information pamphlets for your products. FDA has reviewed the labels for several of your products and found that they violate the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. 321 et seq.] and FDA’s regulations in Title 21 of the Code of Federal Regulations (21 CFR). You can find the Act and FDA’s regulations on FDA’s website at www.fda.gov.
Dietary Supplement Containing Androstenedione
The product labeling for Vee 2000 for Men identifies the product as a dietary supplement and declares androstenedione (among other names, also called 4-androstenedione or 4-androstene-3,17-dione) as an ingredient.
The term "dietary supplement" is defined in 21 U.S.C. 321(ff) [section 201(ff) of the Federal Food, Drug, and Cosmetic Act (the Act)]. Given that you have labeled your Vee 2000 for Men product as a dietary supplement, we assume you have a basis to conclude that androstenedione is a "dietary ingredient" under 21 U.S.C. 321(ff)(1). Assuming that androstenedione is a "dietary ingredient," it would also be a "new dietary ingredient" for which a notification is required under 21 USC. 350b(a)(2) and 21 CFR 190.6.
Under 21 U.S.C. 350b, a dietary supplement that contains a new dietary ingredient (i.e., a dietary ingredient not marketed in the United States before October 15, 1994) shall be deemed adulterated under 21 U.S.C. 342(f) unless it meets one of two requirements:
1. The dietary supplement contains only dietary ingredients that have been
present in the food supply as an article used for food in a form in which the
food has not been chemically altered; or,
2. There is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides FDA with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.
FDA is not aware of any information demonstrating that androstenedione was lawfully marketed as a dietary ingredient in the United States before October 15, 1994. Nor is FDA aware of any information demonstrating that this ingredient has been present in the food supply as an article used for food in a form in which the food has not been chemically altered. In the absence of such information, androstenedione is subject to the .notification requirement for a new dietary ingredient in 21 U.S.C. 350b(a)(2) and 21 CFR 190.6. In that you have not submitted the required notification, your product is adulterated under 21 U.S.C. 342(f)(1)(B) and 350b(a).
Even if the required notification had been submitted, based on what we know now, we know of no evidence that would establish that your product is not adulterated. In the absence of a history of use or other evidence of safety establishing that androstenedione, when used under the conditions recommended or suggested in the labeling of your product, will reasonably be expected to be safe, a product containing androstenedione is adulterated under 21 U.S.C. 342(f)(1)(B) and 350b(a) as a dietary supplement that contains a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. Introduction of such a product into interstate commerce is prohibited under 21 U.S.C. 331(a) and (v). FDA is aware of no history of use or other evidence of safety establishing that androstenedione will reasonably be expected to be safe as a dietary ingredient. In the absence of such history of use or other evidence, your product would be considered adulterated even if you had submitted a notification.
We request that you take prompt action to correct these and any other violations associated with androstenedione and any other products marketed by your firm that contain androstenedione or its derivatives. This warning letter applies to this ingredient and to dietary supplements that contain this ingredient or one of its derivatives. We also remind you that the new dietary ingredient notification requirement applies to all dietary supplements that contain new dietary ingredients that have not been present in the food supply as articles used for food in a form in which the food has not been chemically altered.
Dietary Supplements with Disease Claims
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 are drugs. The label of your product Vee 2000 for Men establishes that it is promoted for conditions that cause the product to be a drug because it bears the following claims:
"Natures [sic] Answer to Prescription Medication"
"[A]id in preventing man’s impotence . . .."
"Natures [sic] alternative to prescription medication."
Furthermore, FDA has no information that your product is safe and effective for the above referenced condition and, therefore, the product is also a new drug under section 201 (p) of the Act [21 USC. 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, during the inspection, our investigator collected product information pamphlets for several of your products, including Natural Vee 2000 for Men and Inner Woman. If these pamphlets accompany these products, they constitute labeling under section 201(m) of the Act [21 U.S.C. 321(m)]. As such, the claims contained in these pamphlets cause these products to be drugs under Section 201(g) of the Act [21 U.S.C. 321 (g)(1)]. The pamphlets’ claims establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. Examples of some of the claims observed in the information pamphlets include:
Natural Vee 2000 for Men
"Natures [sic] answer to Viagra"
"Yohimbe also seems effective in . . . reducing depression . . . ."
"Arginine retards the growth of tumors and cancer . . . . It is also good for liver disorders such as cirrhosis of the liver . . . ."
"VITAMIN E . . . may help prevent heart disease. . . . [Clan aid in healing burned tissue, skin ulcers and abrasions . . . ."
"Zinc and Vitamin C decreases [sic] the probability of blood vessel ruptures and strokes, promotes healing of wounds . . . ."
"GINGKO BILOBA - May improve . . . depression . . . ."
"CHROMIUM - May lower total blood cholesterol, LDL cholesterol, and triglyceride levels."
"BETA-CAROTENE - It may act as a preventative for cancer and heart disease."
Dietary Supplements with Other Labeling Deviations
Your products Natural Vee 2000, Inner Man Gold, and Inner Man are misbranded under Section 403(u) of the Act [21 U.S.C. 343(u)] because they list ginseng as an ingredient, but the ingredient is not derived from a plant classified within the genus Panax. Section 403(u) of the Act, added by the Farm Security and Rural Investment Act of 2002 (Pub. L. 107-171), provides that a food is misbranded if it purports to be or is represented as "ginseng," unless it is an herb or herbal ingredient derived from a plant classified’within the genus Panax. Your products contain an ingredient identified as ginseng within the genus Eleutherococcus. That ingredient may not be declared under a name that includes the term "ginseng" because it is not from the genus Panax.
Finally, the labeling for your products Vee 2000 for Men, Inner Man Gold, and Inner Man include a statement of identity consistent with that of a dietary supplement; however, these products do not comply with the labeling requirements for dietary supplements as follows:
The labels bear types of claims that are authorized under section 403(r)(6) of the Act [21 U.S.C. 343(r)(6)], but the labels do not bear the disclaimer required under that section and 21 CFR 101.93.
The products contain herbal ingredients but fail to identify the part of the plant used for each botanically-derived ingredient, as required by section 403(s)(2) of the Act [21 U.S.C. 343(s)(2)] and 21 CFR 101.4(h).
The labels fail to include in the Supplement Facts panel a heavy bar beneath the last ingredient listed under 21 CFR 101.36(b)(2)(i), as required by 21 CFR 101.36(e)(6). Further, the Supplement Facts panel on the product Vee 2000 for Men fails to separate the dietary ingredients described in 21 CFR 101.36(b)(2) from those ingredients described in 21 CFR 101.36(b)(3), as required in 21 CFR 101.36(e).
You should review the labels for all of your products to ensure that they comply with the applicable requirements of the Act and implementing regulations.
This letter is not intended to be an all-inclusive review of your products or their labeling. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.
Please notify this office in writing within fifteen (15) days of receipt of this letter as to the specific actions you have taken or intend to take to correct these violations, including any steps taken with respect to product currently in the marketplace, 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.
Thomas D. Gardine
FDA Philadelphia District