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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Physician's Choice Inc. 18-Apr-05

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

Public Health Service
Food and Drug Administration

 

555 Winderley Pl, Ste. 200
Maitland, FL 32751



CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER
FLA-05-29

April 18, 2005

Stephan D. Karian, President
Physician's Choice Inc.
101 Mattie M. Kelly Blvd.
Destin, Florida 32541

Dear Mr. Karian:

The Food and Drug Administration (FDA) conducted an inspection at your facility from November 29 through December 1, 2004. The FDA has reviewed your catalog, Physician's Choice News Spring 2004 (which you provided to the FDA investigator as your current catalog), the book Complete Guide to Prostate Health, and your websites at the Internet addresses http://www.physicianschoice net and http://physicanschoicenews.com. Based on our review, your products Super Prostate Formula, Super Cholesterol Formula, Super Cardio Program Healthy Heart and Healthy Arteries, Super Liver Formula, Super Arthritis Formula, Super Glucose Formula, Super Eye, Liver Super Cold & Flu, Super CaIMag, Super Arthritis Cream, Super Slim Anti-Cellulite Cream, FemPro Breast Enhancement Gel, Super Female Formula Breast Enhancement Gel, FemPro Lip Volumizer Serum, Super Female Formula Lip Volumizer, Super Female Formula Cream, Super Thyroid Cream, FemPro, Super Cell Protector Anti-Wrinkle Serum, Super Cell Protector Age Spot Defying Crearn, Super Hair Solutions, Super Cell Protector Daily Enzymatic Toner & Enzymatic Resurfacing Mask, Super Cell Protector Daily Enzymatic Cleanser, Super Cell Protector Rejuvenating Enzymatic Toner, Super Cell Protector 7-Day Enzymatic Resurfacing Mask, Super Cell Protector Rejuvenating Enzymatic Cleanser, Super Cell Protector Acne Clear, Super Carbo Blocker, Super Carbo Blocker 2, Super Lipo Blocker and Super Slim are in violation of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and FDA's regulations through links on FDA's Internet home page at www.fda.gov.

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)(13))] . Articles other than food that are intended to affect the structure or function of the body of man or other animals are drugs [section 201(g)(1)(C) of the Act (21 U.S.C. § 321(g)(1)(C))]. There is, an exception from this definition for dietary supplements whose labeling includes claims about the supplement's effect on the structure or function of the human body (structure/function claims), provided that ail requirements of section 403(r)(6) of the Act (21 U.S .C. § 343(r)(6)) are met. However, claims that dietary supplements are useful to prevent, diagnose, mitigate, treat, or cure disease (disease claims), except for FDA-authorized health claims about reducing the risk of a disease ., cause the products to be drugs. Further, only products that are intended for ingestion may be lawfully marketed as dietary supplements. Topical products and products intended to enter the body directly through the skin or mucous tissues, such as transdermal or sublingual products, are not dietary supplements . For these products, both disease and structure/function claims may cause them to be drugs.

A. UNAPPROVED NEW DRUGS

Oral Use Products

The labeling for your products listed below bears disease claims that cause these products to be drugs under section 201(g)(1)(B) of the Act. Examples of such claims include the following:

  • Super Prostate Formula
    Complete Guide to Prostate Health

      • "Lycopene [an ingredient in the product] . . . . is a carotenoid . . . shown to be twice as effective as Beta Carotene and 100 times more effective than vitamin E in counteracting harmful free radicals that cause cancer. Lycopene has been shown to be effective in preventing prostate cancer in men in several medical studies . . . . Normally, the level of Lycopene is the highest of all the carotenoids present in the prostate gland, which may be the reason for its anti-prostate cancer
        capabilities."
      • "Pygeum Africanum has been used to treat BPH in Europe."

       

  • Super Cholesterol Formula
    Catalog

  • "[S]upports lower cholesterol levels with all natural ingredients . . . . Inositol . . . can help to prevent high cholesterol and hardening of the arteries."
  • "Gum Guagul [an ingredient in the product] : Total blood cholesterol reduction in the range of 22 to 27% is being achieved with the use of gum guggul alone, irrespective of dietary modifications - equal to some modem day cholesterol lowering drugs. . . . [I]t brings down levels of unwanted LDL and VLDL components which clog the arteries, and at the same time raises the anti-clogging HDL. Guggul also reduces blood triglycerides."
  • "Vitamin B6 plays a role in cancer immunity and aids in the prevention of arteriosclerosis."
    Internet
  • "Reduce your risk of heart disease, America's #1 killer; order the Super Cholesterol Formula™ today!"
  • "Super Cholesterol Formula has the ingredients that have been known to lower cholesterol levels, without the side effects that you might get from taking prescription drugs."
  • Website article: Cholesterol - The #1 Risk Factor for Heart Disease
      • "Garlic and Borage oil [ingredients in the product] decrease the LDL cholesterol while increasing the level of the HDL cholesterol ."
      • "Typically, the cholesterol levels [of patients taking Super Cholesterol Formula] will drop 15-35% in a 4-12 week period, while triglyceride levels will drop from 30-40%."
      • "Take the first step in reducing your risk of having heart disease or stroke and begin using Super Cholesterol Formula™ today."
  • Represents the product as an alternative to statin drugs.
  • Super Cardio Program Healthy Heart and Healthy Arteries
    Catalog and Internet
  • "Step 1 - Healthy Heart™" and Step 2 - Healthy Arteries™ reduced the risk of heart attack and stroke."
    Internet
  • "A two step program designed to reduce the risk of heart disease . . . ."
  • "You can effectively fight heart disease and stroke . . . .start using the Super Cardio Program™" - the state of the art protection from cardiovascular disease."
  • "Website article : Natural Approach to a Healthy Heart
      • "Reduced levels of CoQ10 [an ingredient in Healthy Heart] promote atherosclerosis. In clinical studies, CoQ10 was beneficial for high blood pressure, cardiomyopathy, heart failure, angina and even cancer."
      • "Cayenne pepper [an ingredient in Healthy Arteries] . . . . inhibits platelet aggregation and improves blood flow, sometimes with immediate results . Some herbalists recommend using it as the first aid in case of a suspected heart attack. . . . Cayenne has been known to reverse plaque formation on the arterial walls."
  • Super Liver Formula
    Internet and Catalog
  • "Do you suffer from . . .migraines, . . . irritable bowel syndrome . . .? If you've tried unsuccessfully to deal with some of these symptoms . . . then Super Liver Formula™ may be your ultimate answer."
      • "Clinical studies have shown that Artichoke Leaf [an ingredient in the product] may lower cholesterol and trigiyceride levels . . . ."
      • "Bee Pollen [an ingredient in the product] may . . . act as a natural antibiotic."
      • "Research suggests that Royal Jelly [an ingredient in the product] may lower cholesterol, improve the LDL/HDL ratio . . . ."

       

  • Super Arthritis Formula
  • Product name
    Catalog
      • "The exclusive formulation of Super Arthritis Formula™ contains a unique blend of three ingredients that alleviate pain, swelling and overall discomfort in your joints . They also support your body to rebuild cartilage, helping you to prevent the onset of arthritis symptoms before they begin!"
        Internet
      • "Super Arthritis Formula . . . contains natural anti-inflammatory's [sic] in a capsule form, to alleviate pain, swelling and overall discomfort in your joints."
  • Super Glucose Formula
    Internet and catalog
  • "Super Glucose Formula™ is . . .designed to effectively help reduce your glucose levels - a crucial function for those people with diabetes."
  • "Super Glucose Formula contains Benaba Leaf; a phytochemical complex that contains high levels of Corosolic Acid, clinically shown to have insulin-like effects. Benaba Leaf exhibits glucose-lowering properties."
  • Super Eye Formula
    Catalog and Internet
    "Are you concerned about. . . cataracts, macular degeneration . . .?. . . Super Eve Formula T"' :vas designed to . . . help preserve the gift of sight. . . ."
  • "A 12-year Harvard University study found that beta-carotene (vitamin A) [an ingredient in the product] reduced the risk of cataracts . . . .
  • Ascorbic acid [an ingredient in the product] has been proven in studies to reduce the risk of cataracts by up to 75%"
  • "Zinc helps to keep membranes moist and strong, protecting them from glaucoma and progressive vision loss."

  • Super Cold & Flu
  • Product name
    Catalog and Internet
  • "Millions get sick during the cold and flu season. Where can you turn for help? Introducing the all-natural Super Cold & Flu™ formula!"
  • "Wild Oregano [an ingredient in the product] . . . has been used to to [sic] help, address cough, fever, chills, fatigue, congestion, sore throat, muscle, aches, and more. Wild Oregano oil has been used topically to help fight . . . yeast infections . . . . Olive Leaf [an ingredient in the product] has also been used in the fight against colds and fevers."
  • Super CaIMag
    Catalog and Internet
  • "Even children with Attention Deficit Disorder (ADD). . .have been known to benefit from . . . Super CaIMag™. In fact Super CaIMag™ may be the best alternative to harsh drugs (such as Ritalin) of which long-term effects are not known!"
  • "Low levels of Vitamin D [an ingredient in the product] have been linked to arthritis and multiple sclerosis."
    Internet
  • "Website article: Protect Yourself From Dangerous Mineral Deficiencies!
      • "Some evidence suggests that vitamin D may even help prevent cancer of the breast, colon, pancreas and prostate."
  • Super Carbo Blocker, Carbo Blocker 2, and Super Lipo Blocker
    Internet
  • "Pages for each product link to an article entitled : Obesity: An American Epidemic
    The article lists the following diseases and implies the product is useful in preventing or treating them: obesity; cancer of the breast, uterus, prostate, and colon; depression ; diabetes; heart disease; hypertension; and osteoarthritis.

Topical and other Non-Oral Use Products

The labeling for your products listed below bears claims that cause these products to be drugs under section 201(g)(1)(B) of the Act, section 201(g)(1)(C) of the Act, or both. Examples of such claims include the following:

  • Super Arthritis Cream
  • Product name
    Catalog and Internet
    "Super Arthritis Cream™ is specifically formulated to provide fast-acting relief from the minor aches and pains of arthritis, backaches and muscle strain. Its dual-action ingredients provide penetrating heat that gets right at the source of your pain and provide hours of soothing comfort. . . . Rub on Super Arthritis Cream™ and rub out the pain!"
  • Super Slim Anti-Cellulite Cream (name on product label; referred to on website and in catalog as "Super Slim Cream")
    Product label, catalog, and Internet
  • "[D]esigned to cosmetically reduce the size of your hips, thighs, waist and buns."
    Product label
  • "[C]ontains Algicium C, a compound which has been shown in studies to help cosmetically reduce the size of your hips, thighs, waist and buns."
    Catalog and Internet
  • "[C]ontains Algicium C, a compound which has been shown in studies to help cosmetically reduce the size of the hips, thighs and waist."
  • FemPro Breast Enhancement Gel
    Catalog
  • "FemPro™ breast enhancement gel was designed to help tighten, lift and firm breast appearance."
  • "FemPro™ breast enhancement gel . . . was designed to help assist collagen synthesis and tissue restructuring . Results of clinical trials show an increase in cell stimulation, firmness and tonicity."
  • "FernPro™ breast enhancement gel helps address the following:
    Contour and firmness
    Wrinkled chest and cleavage area"
  • Super Female Formula Breast Enhancement Gel
    Internet
  • "Super Female Formula™ Breast Enhancement Gel was designed to help tighten, lift and firm breast appearance."
  • "Super Female Formula™ Breast Enhancement Gel . . .was designed to help assist collagen synthesis and tissue restructuring . Results of clinical trials show an increase in cell stimulation, firmness and tonicity."
  • "Super Female Formula™ Breast Enhancement Gel helps address the following:
    Contour and firmness
    Wrinkled chest and cleavage area"

  • FemPro Lip Volumizer Serum
    Catalog
  • "A 30-day study of the unique patented peptide complex found in FemPro™ lip volumizer serum produced an increase in lip volume, a reduction in surface folds . . . ."
  • "This product was designed to address the following
    Lip volume, contour and definition . . . .
    Deep lines and wrinkles."
  • Super Female Formula Lip Volumizer
    Internet site
  • "A 30-day study of the unique patented peptide complex found in Super Female Formula™ Lip Volumizer produced an increase in lip volume, a reduction in surface folds. . . ."
  • "This product was designed to address the following
    Lip volume, contour and definition of the lips. . . .
    Deep lines and wrinkles."
  • Super Female Formula Cream
    Internet site
  • "[S]upport both bone health and hormonal balance."
  • "[T]he undesirable effects of estrogen dominance include headaches, decreased sex drive, weight gain, PMS, depression, breast tenderness and infertility. Super Female Formula™ Cream provides the natural progesterone (USP) to help address these symptoms."
  • Super Thyroid Cream
    Catalog
      • "The undesirable effects of estrogen dominance include headaches, decreased sex drive, uterine tumors and cancer, weight gain, PMS, depression, breast tenderness and infertility. Super Thyroid Cream™ provides the natural progesterone (USP) to help balance these symptoms."
      • "[S]upport both thyroid health and hormonal balance."
  • FemPro
    Catalog
  • "[S]upport bone health and hormonal balance."
  • "At the onset of menopause, many women experience symptoms such as hot flashes, night sweats, mood changes, and vaginal dryness and/or discomfort. These symptoms may also occur after a hysterectomy. FemPro™ helps with many of these symptoms of menopause."
  • "Promote Bone Health"
  • "The use of natural progesterone cream has been shown not only to decrease bone loss, but also to reverse osteoporosis and increase bone mass."
  • "Help Improve PMS Symptoms"
  • "FemPro™ may be helpful with the symptoms of PMS and menstruation, such as water retention, breast soreness, migraines, mood swings, cramping, diarrhea, constipation and heavy bleeding."
  • "Try rubbing FemPro™ on your lower abdomen during menstrual cramping, or on the back of your neck or temples during migraines."
  • Super Cell Protector Anti-Wrinkle Serum
    Catalog
  • "Contains chart that purports to show reduction in, e.g., wrinkle depth and density with use of the product.
    Internet
  • "Super Cell Protector™ anti-wrinkle serum was designed . . .for erasing wrinkles and restoring the dermal matrix."
  • Super Cell Protector Age Spot Defying Cream
    Catalog and Internet
  • "The Japanese fruit extract, Citrus Unshia [an ingredient in the product], has been shown to reduce the intensity of age spots . . .."
  • "Super Cell Protector"" age spot defying cream was designed to address the following:
    Age spots and skin discolorations
  • "Lighter-looking, more even-toned skin"
  • "If you want younger looking skin without the damage from aging, then Super Cell Protector™ age spot defying cream is for you."
  • Super Hair Solutions (sometimes referred to as "Super Solutions Program" on website)
    Catalog and Internet
    "If you suffer from hereditary hair loss, thinning hair, or male pattern baldness, help is on the way! Introducing the Super Hair Solutions™, a 3-step program designed to help assist regrowing hair, thus addressing hair loss."
  • "The complete Super Hair Solutions™ program consists of 1 bottle of Super Hair, Skin & Nails™, 1 bottle of Super Hair Solutions™ Serum and 1 bottle of Super Hair Solutions™ Shampoo. Together they form a unique, comprehensive 3-step program designed to help promote healthy hair growth."
  • "Step 1 - Super Hair, Skin & Nails™ contains . . . . MSM, an organic sulfur, . . . known to speed healthy hair growth . . . . Fo-Ti has been known to help minimize hair loss and restore your hair's natural color. . . . Saw Palmetto helps prevent your hair follicles from absorbing DHT [dihydrotestosterone]."
  • "Step 2 - Super Hair Solutions™ Serum is a topical serum that contains FDA-approved minoxidil to help enlarge shrinking follicles, promoting your hair cycle's growth phase. This may allow your hair to become thicker and longer."
  • "Step 3 - Super Hair Solutions Shampoo . . . designed to help stimulate scalp circulation, supporting maximum volume . . . ."
  • Super Cell Protector Daily Enzymatic Toner & Enzymatic Resurfacing Mask and Super Cell Protector Daily Enzymatic Cleanser
    Catalog
      • "[M]ay help . . . breakouts of acne prone skin . . . ."
  • Super Cell Protector Rejuvenating Enzymatic Toner, Super Cell Protector 7-Day Enzymatic Resurfacing Mask, and Super Cell Protector Rejuvenating Enzymatic Cleanser
    Internet
      • "[M]ay help . . . breakouts of acne prone skin . .. ."
  • Super Cell Protector Acne Clear
    Catalog and Internet
      • "Super Cell Protector T"' acne clear is a powerful complex designed to effectively help fight acne."
      • "[C]ontains three key ingredients to address the . . . core causes of acne prone skin . . . ."

       

Further, the products "Super Female Formula Cream," "Super Thyroid Cream," and "FemPro" are subject to a final regulation codified in Title 21, Code of Federal Regulations (21 CFR), Section 310 .530, Topically Applied Hormone-Containing Drug Products For Over-The-Counter (OTC) Human Use. This regulation states that "[a]ny OTC drug product that is labeled, represented, or promoted as a topically applied hormone-containing product for drug use, . . . is regarded as a new drug . . . " [This section does not apply to hydrocortisone for OTC topical use.-- drop this in a footnote if included] The product labeling indicates that it contains 'natural progesterone,' which constitutes an implied therapeutic or physiological claim that the product is intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease or to affect the structure or function of the body.

Additionally, drug products that are available over-the-counter (OTC) for external use as hair growers or for hair loss prevention are subject to the final rule covering Flair Grower and Hair Loss Prevention Drugs for OTC Human Use, Title 21, Code of Federal Regulations (21 CFR) section 310 .527. As stated in this regulation, no OTC drug product for external use offered as a hair grower or for hair loss prevention can be considered to be generally recognized as safe and effective for its intended use.

Finally, your products Super Cell Protector Daily Enzymatic Toner & Enzymatic Resurfacing Mask, Super Cell Protector Daily Enzymatic Cleanser, Super Cell Protector Rejuvenating Enzymatic Toner, Super Cell Protector 7-Day Enzymatic Resurfacing Mask, Super Cell Protector Rejuvenating Enzymatic Cleanser, and Super Cell Protector Acne Clear are promoted for the over-the-counter (OTC) treatment of acne and therefore are subject to the acne final regulation in 21 CFR sections 333 .301, 333.310, 333.320, and 333 .350 . Because the labeling and formulation of your products do not comply with the regulations regarding acne products, your products cannot be considered to be generally recognized as safe and effective for their intended use in treating acne.

Based on the claims noted above, the products listed in this section are drugs under the Act since they are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or to affect the structure or function of the human body [section 201(g)(1)(B)-(C) of the Act] . Because the 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).

B. UNSUBSTANTIATED STRUCTURE/FUNCTION CLAIMS

Under section 403(r)(6) of the Act [21 U.S.C. § 343(r)(6)], dietary supplement labeling may include claims about the supplement's effect on the structure or function of the human body (structure/function claims), provided that certain requirements are met. One of these requirements is that the manufacturer of a dietary supplement bearing a "structure/function" claim must have substantiation that the claim is truthful and not misleading [21 U.S .C. § 343(r)(6)(B)].

Your products Super Carbo Blocker, Super Carbo Blocker 2, and Super Lipo Blocker are labeled as dietary supplements but are marketed with disease claims that subject the products to regulation as drugs. In addition to the disease claims in the labeling for these products that cause them to be unapproved new drugs, the unsubstantiated structure/function claims in your labeling misbrand the products as dietary supplements . Further, your Internet and catalog labeling makes unsubstantiated structure/function claims for the product Super Slim, which is also labeled and marketed as a dietary supplement. Examples of unsubstantiated structure/function claims for these products include the following:

  • Super Carbo Blocker
    Catalog and Internet
  • "Hydroxycitric Acid (HCA) , found in a fruit called garcinia cambogia [an ingredient in the product], has been shown to help inhibit the conversion of carbohydrates to fat."
    Catalog
  • "Help Inhibit Carbohydrate Absorption!"
    Internet
  • " Website article: Obesity: An American Epidemic
  • "Chitosan [an ingredient in the product] inhibits absorption of fat and bile acids . . . . [It] actually binds up to 12 times its weight of lipids (fats). It's as if you are not eating the fat at all!"
  • "HCA reduces the syntheses [sic] of fat from carbohydrates by 40-70%. . . ."
  • Super Carbo Blocker 2
    Internet
  • "Super Carbo Blocker 2 . . . especially designed to help inhibit the conversion of sugar into fat."
  • "Product page links to same website article as Super Carbo Blocker (see above for examples of unsubstantiated claims for chitosan, an ingredient in the product).
    Catalog
  • "Help Block Carb conversion to Fat!"
  • Super Lipo Blocker
    Catalog
  • "Help Inhibit Fat Absorption!"
  • "Chitosan, the main ingredient in Super Lipo Blocker™, . . .absorbs several times its own weight in dietary fats!"
  • "Research demonstrates that Chitosan . . . bind[s] with dietary fats and act[s] like a fat sponge in your digestive tract."
    Internet
  • "Product page links to same website article as Super Carbo Blocker (see above for examples of unsubstantiated claims for chitosan).
  • Super Slim
    Catalog and Internet
  • "Designed to help inhibit carbohydrate and fat absorption . . . ."
  • "Ingredients in Super Slim™ have been shown to: Help inhibit carbohydrate absorption - lowered carbohydrate absorption means less carbohydrates that are available to convert to excess glucose."

We have reviewed these claims and have concluded that they are not supported by competent and reliable scientific evidence. Because these claims lack substantiation, they are false or misleading, and cause your products to be misbranded within the meaning of sections 403(a)(1) and 403(r)(6)(B) of the Act [21 U.S.C. § 343(a)(1) and 343(r)(6)(B)] . It is a violation of section 301(a) of the Act to introduce or deliver for introduction into interstate commerce any food, including a dietary supplement, that is misbranded [21 U.S.C. § 331(a)]. It is a violation of section 301(k) of the Act to commit any act with respect to a food if such act is done while such article is held for sale (whether or not the first sale) after shipment in interstate commerce and results in such article being misbranded [21 U.S.C. § 331(k)].

This letter is not an all-inclusive review of your website, other labeling, and the products that your firm markets. For example, the unlawful disease treatment and prevention claims in your product catalog and on your website were too numerous to list in this letter . It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.

You should take prompt action to correct any violations, including the violations identified in this letter. Failure to do so may result in enforcement action without further notice. The Act authorizes injunctions against manufacturers and distributors of illegal products and seizure of such products [21 U.S.C. §§ 332 and 334].

Please advise this office, in writing and within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed. If you have scientific evidence that you believe substantiates the structure/function claims for your weight loss products, you should include that in your response.

Your reply should be addressed to Shari H . Shambaugh, Compliance Officer, U.S . Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida 32751.

Sincerely,
/s/

Emma R . Singleton
Director, Florida District