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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Great American Products, 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-05-26

April 18, 2005

Stephan D . Karian, President
Great American Products 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. FDA has reviewed your catalog, Great American Health & Nutrition Summer 2004 (which you provided to the FDA investigator as your current catalog), and your website at the Internet address http://www.greatamericanproducts.com. Based on our review, we conclude that your products Prostate Assist, Cholesterol Assist, Ultimate Cardio Program Heart Support and Artery Support, Maximum Liver Advantage, Arthritis Assist Supplement, Ultimate Glucose Advantage, Essential Eye Support, Ultimate Cold & Flu, CalAbsorb, Carbo Blocker, Arthritis Assist Cream, Anti-Cellulite Slim Cream, Female Harm. Breast Enhancement Gel, Master Cell Protector Lip Volumizer Serum, Female Balance, Master Cell Protector Age Spot Defying Cream, Hair Maximizer Program, Fat Blaster, Ultimate Slim Ephedra-Free, and ChitoSlim 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)(B))] . Articles other than food that are intended to affect the structure or function of the body of man or other animals are also 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 truthful and non-misleading claims about the supplement's effect on the structure or function of the human body (structure/function claims), provided that all 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:

  • Prostate Assist

    Catalog

      • "Lycopene [an ingredient in the product] . . .has been shown in numerous medical studies to be effective in helping to reduce the risk of prostate cancer."
      • "Prostate Assist™" is specifically formulated with all-natural ingredients that have clinically been shown to alleviate
        symptoms associated with prostate enlargement, without many of the side effects associated with conventional medications and treatment!"
  • Cholesterol Assist

    Internet and Catalog

      • "Studies show that lowering high cholesterol levels may reduce your risk of future terminal cardiovascular problems by 30%."
      • "Cholesterol Assist™" supports lower cholesterol levels with all natural ingredients. . . .Inositol lowered cholesterol up to 10% and triglyceride levels up to 26% . . . . Policosanol lowered LDL cholesterol up to 25.6% and raised good HDL cholesterol up to 28 .4% in just 12 weeks!"
      • "Reduce your risk of heart disease, America's #1 killer ; order the Cholesterol Assist™" today."

    Internet

      • "Cholesterol Assist - has the ingredients that have been known to lower cholesterol levels without side effects that you might get from taking prescription drugs."

       

  • Ultimate Cardio Program Heart Support™" and Artery Support™

    Catalog and Internet

      • "Step 1 - Heart Support™" and Step 2 - Artery Support™" reduced the risk of heart attack and stroke."

Internet

      • "A two step program designed to reduce the risk of heart disease . . . ."
      • "Reduced levels of CoQ10 [an ingredient in Heart Support] can cause atherosclerosis. In clinical studies, CoQ10 was helpful in treating high blood pressure, cardiomyopathy, ' heart failure, angina, and even cancer."
      • " Website article: You Can Have a Naturally Healthy Heart! "Cayenne pepper [an ingredient in Artery Support] . . . . inhibits platelet aggregation and improves blood flow, sometimes with immediate results. Some herbalists recommend using it as first aid in case of a suspected heart attack. Cayenne has been known to reverse plaque formation on the arterial walls."

Catalog

      • "Ultimate Cardio Program . . . reduced the risk of heart attack and stroke."
  • Maximum Liver Advantage

    Internet and Catalog

      • "Do you suffer from . . . migraines, . . . irritable bowel syndrome . ..? If you've tried unsuccessfully to deal with some of these symptoms . . . then Maximum Liver Advantage™ may be your ultimate answer."
      • "Clinical studies have shown that Artichoke Leaf [an ingredient in the product] may lower cholesterol and triglyceride 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 . . . ."

    Internet

      • Website article: Are You Taking The Life Out Of Your Liver? The article suggests that your product and its ingredients are useful for treating numerous diseases . Some examples include:
        • "Symptoms of liver imbalance include . . . anxiety, depression, . . . food allergies, . . .as well as conditions like Alzheimer's and Parkinson's Disease."
        • "Over 100 scientific research papers have found that milk thistle may be proven effective against chronic hepatitis, cirrhosis and liver damage."
        • "Artichoke . . . . has been proven in clinical studies to lower cholesterol . . . . Artichoke is helpful in restoring liver health by relieving the symptoms of liver damage, diseases and insufficiency, plus . . . chronic constipation and the prevention of gallstones."

         

  • Arthritis Assist Supplement

    Product name
    Catalog and Internet

  • "The exclusive formulation of Arthritis Assist™" 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!"
  • Ultimate Glucose Advantage

    Catalog and Internet

  • "Ultimate Glucose Advantage™" is . . . designed to effectively help reduce your glucose levels- a crucial function for those people with diabetes."
  • "Ultimate Glucose Advantage""" 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."

    Internet

  • " Website article entitled "Could You Have Undiagnosed Diabetes?" discusses diabetes causes, risks, and provides information about studies that have been performed using various nutrients that make up Ultimate Glucose Advantage and the effect of these nutrients on symptoms of diabetes, such as glucose intolerance.
      • "With Ultimate Glucose Advantage™", you may be able to escape the terrible effects of adult-onset diabetes!"
  • Essential Eye Support:

    Catalog and Internet

  • "Are you concerned about . . .cataracts, macular degeneration . . .? . . . Essential Eye Support™" was designed to . . . help preserve the gift of sight. . . ."
  • "A 12-year Harvard University study found that betacarotene (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."
  • Ultimate 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 Ultimate Cold & Flu™" formula!"
  • "Wild Oregano [an ingredient in the product] . . . has been used 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."
  • CalAbsorb

    Catalog and Internet

      • "Even children with Attention Deficit Disorder (ADD) . . . have been known to benefit from . . . CalAbsorb®. In fact CalAbsorb® 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: Calcium: Your Key to Optimum Health!
        • "Some evidence suggests that vitamin D may even help prevent cancer of the breast, colon, pancreas and prostate."
  • Carbo Blocker

    Catalog and Internet

      • "Goat's Rue [an ingredient in the product] is so effective, a glucose lowering drug was fashioned after it. Used in Europe for centuries for the treatment of diabetes, the leaves of this plant contain active ingredients called guanides that are responsible for its antidiabetic effects. . . . Bi-guanides [derivatives of guanides] have been patented for use as antidiabetic agents and are found in the glucose lowering drug, Glucophage. However, Goat's Rue, in its natural form, helps to regulate blood sugar without the side effects of drugs."

    Internet

      • "Website article: How to eat the Carbs and Lose the Fat! Lists the following diseases or conditions and implies the product is useful in preventing or treating them : obesity, heart disease, diabetes, stroke, and cancer.

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:

  • Arthritis Assist Cream

    Product name
    Catalog and Internet

      • "Arthritis Assist™ Cream is specially formulated to provide fast-acting relief from the minor aches and pains of arthritis . . .. Its dual-action ingredients provide penetrating heat that gets right at the source of your pain and provide "[sic] hours of soothing comfort. . . . Rub on Arthritis Assist™ Cream and rub out the pain!"

       

  • Anti-Cellulite Slim Cream

Catalog and Internet

      • "Anti-Cellulite Slim Cream™ was designed to cosmetically help reduce the size of your hips, thighs, waist and buns. Anti-Cellulite Slim Cream™ contains Algicium C, a compound which has been shown in studies to help cosmetically reduce the size of your hips, thighs and waist."
  • Female Harmony Breast Enhancement Gel

Catalog and Internet

  • "Female Harmony™ breast enhancement gel was designed to help tighten, lift and firm breast appearance ."
  • "Female Harmony™ 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."
  • "Female Harmony™ breast enhancement gel helps address the following:

    Contour and firmness
    Wrinkled chest and cleavage area

  • Master Cell Protector Lip Volumizer Serum

    Catalog and Internet

      • "A 30-day study of the unique patented peptide complex found in Master Cell Protector™ 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 of the lips
        Deep lines and wrinkles"

  • Female Balance Natural Progesterone (USP) Cream

    Catalog and Internet

      • "[T]he undesirable effects of estrogen dominance include headaches, decreased sex drive, weight gain, PMS, depression, breast tenderness and infertility. Female Balance™ provides the natural progesterone (USP) to help address these symptoms.

       

  • Master 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 . . . ."
      • "Master 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 Master Cell Protector" age spot defying cream is for you."

 

  • Hair Maximizer Program

    Catalog and Internet

  • "If you suffer from hereditary hair loss, thinning hair, or male pattern baldness, help is on the way! Introducing the Hair Maximizer™, a 3-step program designed to help assist regrowing hair, thus addressing hair loss."
  • "The complete Hair Maximizer™ program consists of 1 bottle of Ultimate Hair, Skin & NaiIs™, 1 bottle of Hair Maximizer™ Serum and 1 bottle of Hair Maximizer™ Shampoo. Together they form a unique, comprehensive 3-step program designed to help promote healthy hair growth."
  • "Step 1 - Ultimate 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 - Hair Maximizer™ 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."

Further, the product "Female Balance" is 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 . . . "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 Hair 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.

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, 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 [21 U.S .C. § 343(r)(6)(A)] . 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 product Carbo Blocker is labeled as a dietary supplement but is marketed with disease claims that subject it to regulation as a drug. In addition to the (This section does not apply to hydrocortisone for OTC topical use) disease claims in the labeling for this product that cause it to be an unapproved new drug, the unsubstantiated structure/function claims in your labeling misbrand the product as a dietary supplement. Further, your Internet and catalog labeling makes unsubstantiated structure/function claims for the products Fat Blaster, Ultimate Slim, and ChitoSlim, which are also labeled and marketed as dietary supplements. Examples of unsubstantiated structure/function claims for these products include the following:

  • Carbo Blocker
    Catalog and Internet
      • "CarboBlocker™ was designed to help block the fattening affects [sic] of carbohydrates. . .!"

    Internet

      • "Carbo Blocker - helps to inhibit the conversion of carbohydrates to sugar. . .!"
        Catalog
      • "Help Block Carb Conversion to Fat!"
  • Fat Blaster
    Catalog
      • "Designed to Help Inhibit the Fattening Effects of Carbohydrates"
      • "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."

       

  • Ultimate Slim Ephedra-Free
    Catalog and Internet
      • "Designed to help inhibit carbohydrate and fat absorption . . . ."
      • "Ingredients in Ultimate Slim® have been shown to: Help inhibit carbohydrate absorption - lowered carbohydrate absorption means
        less carbohydrates that are available to convert to excess glucose."
        Internet
      • "Ultimate Slim Ephedra Free is a carbohydrate blocker, . . .fat blocker . . . ."
      • " Website article : Do You Want to Lose Weight Easily?
      • "[C]hitosan . . . naturally bonds with fat to carry it out of your body - it literally takes the fat out of the foods you eat!"
      • "[C]hitosan's unique properties give it the ability to significantly bind fat, acting like a `fat sponge' in the digestive tract."
      • "Chitosan is effective because it prevents fat from being absorbed by the body."

       

  • ChitoSlim
    Internet
  • "ChitoSlim combines Chitosan with Vitamin C and chromium to form a unique fat absorbing supplement that is designed to absorb fat from your food."
  • Article: Chitosan : A Major Breakthrough in Weight Loss
    "Every gram of Chitosan [an ingredient in the product] absorbs up to 6 grams of fat. By taking two grams of Chitosan (equivalent to 4 ChitoSlim™ tablets) you will absorb up to 12 grams of fat per day."
    Catalog
  • "Designed to Help Absorb Fat from Your Meals"
  • "Chitosan, the main ingredient in ChitoSlim™, . . .absorbs several times its own weight in dietary fats!"
  • "[C]hitosan . . .bind[s] with dietary fats and act[s] like a fat sponge in your digestive tract."

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 Shad 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