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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Advantage Nutraceuticals, LLC 25-Mar-05

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

Public Health Service
Food and Drug Administration

 

555 Winderley PI., Ste. 200
Maitland, FL 32751


CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER

FLA-05-22

March 25, 2005

Thomas E. Nelson, Owner and Manager
Advantage Nutraceuticals, LLC
906 Skipper Avenue
Fort Walton Beach, Florida 32547

Dear Mr. Nelson:

The Food and Drug Administration (FDA) conducted an inspection at your facility at the above address on December 2, 2004. During that inspection, the investigator collected labeling associated with your products, CoraIMax™, EIIagiMax®, Oxy Plus™, ZanaMax™, Advanced Arthritis Support™ and Fat on Fire. In addition, we reviewed labeling on your website, http://www.welcometoadvantage.com or http://www.welcome2advantage.com. A review of this labeling found the products are being offered are promoted for conditions that cause these products to be drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U .S .C. § 321(g)(1)] . These claims on your labeling, including your website, establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act. You can find the Act and FDA's regulations through links on FDA's Internet home page, http://www.fda.gov.

The following statements, unless otherwise noted from brochures or product labels, are examples of claims observed in your labeling from your website:

CoraIMax™

  • "The cesium [an ingredient in the product] has been found . . . to be extremely effective in the fight against cancer."

  • "If you will supplement your diet with CoraIMax™ . . . you will make your body a hostile environment for degenerative diseases . . . ."

  • "In addition, over 150 degenerative diseases have been linked to acidosis including cancer, diabetes, arthritis, heart disease, gall and kidney stones and many more. An acidic environment in the muscles surrounding our arteries can cause them to harden . This leads to cracks in the arterial walls, and then to clogging of the arteries, and eventually can cause strokes and heart attacks. Cancer cells feed on fermentation of glucose in an acid environment . . .. CoraIMax™ is your body's solution to acidosis . . . ."

EIIagiMax®

  • "EIIagiMax® . . .is recommended . . .for major degenerative diseases, such as cancer."

  • "Ellagic Acid [in the product] allows the body to create Apoptosis n cancer cells. They die when they reproduce as do normal cells."

  • "If you fill your body with ellagic acid, your ordinary cells will not mutate into cancer cells."

  • Brochure: "Clinical tests . . .have shown that ellagic acid acts a scavenger to bind cancer-causing chemicals, making them inactive. Ellagic acid also protects DNA by blocking carcinogens . . . . [E]Ilagic acid has been shown to reduce the incidence of cancer."

  • Brochure : "EIIagiMax™ . . .may be the most effective way to fight the battle with Cancer." Lists the following diseases and implies the product is useful in treating or preventing them : Cervical Cancer Cells-HPV (human papilloma virus) and cancers of the breast, pancreas, esophagus, skin, colon and prostate.

Oxy PIus™

  • "Dr Walburg discovered the best means of preventing cancer was to saturate the body with oxygen. There is no better way to give your body the building blocks it needs, for oxygen respiration, than to supplement your diet with Oxy Plus, three times a day."

ZanaMax™

  • "[S]tudies have demonstrated that astaxanthin [an ingredient in the product] may have beneficial properties for human health, including Anticancer effects on human cells . . . Anti-inflammatory properties . . ."

Advanced Arthritis Support™

  • "CMO [an ingredient in the product] is a modified fatty acid used to treat rheumatoid arthritis. . . . CMO. . . relieves arthritis pain, reduces inflammation . . . ."

  • "A new miracle cure for arthritis ."

Fat on Fire

  • "A pill that kills the appetite and attacks obesity . . ."

  • "Features 500 mg of Hoodia Gordoni Cactus powder in each capsule. . . .[T]he first human clinical trial . ..the company chose a morbidly obese group . . . . The group on Hoodia had reduced their food intake by 1000 calories a day."

Claims from Testimonials:

  • "I was told I had prostate cancer. . . . I started a course of Coral calcium (CoraIMax™), ElIagiMax® and Oxy Plus. After 4-5 weeks I had another PSA check and my count was down from eleven to one point one."

  • "PSA of 0.1 . This is full remission and I am no longer on chemo/hormone treatments . I'm pleased with the results of my raspberries (EIIagiMax®) and coral calcium (Coral Max™)."

  • "One of her eyes has had 6 surgeries in one year for a detached retina and the other was very weak. I got her started on Zanamax about 2 months ago. She went to the eye doctor . . .her vision . . .has gone from 20/50 to 20/20."

Ellagi Cream™

In addition, FDA reviewed labeling for your product Ellagi Cream™ collected at the inspection and from your website. Topical products and products intended to enter the body directly through the skin or mucosal tissues, such as sublingual products, are not dietary supplements or foods. Articles other than food that are intended to affect the structure or any function of the body of man are drugs [Section 201(g)(1 )(C) of the Act; 21 U.S.C. § 321(g)(1)(C)]. Claims that these products are useful in the cure, mitigation, treatment, or prevention of disease also cause these products to be drugs under section 201(g)(1)(B) of the Act [21 U.S.C . § 321 (g)(1)(13)]. The following claims cause your topical product Ellagi Cream to be a drug.

Claims for the ingredients in your product :

Ellagic Acid

  • "[H]elps to reduce bacteria on the skin and soothe inflammation . . . ."

  • "[A]bility to promote healing and the rebuilding of tissues ."

Farnesol

  • "[W]orks as a controlling agent for skin color."

Gallic Acid

  • "[H]elps to stimulate the immune system, acts to control excessive hormone action, reduces bacteria on the skin and has anti-viral properties."

Lutein

  • "[H]as potent anti-cancer properties . . . ."

  • "[R]etard[s] the damage induced by oxidation."

Caffeic and Ferrulic acids

  • "[P]owerful . . .anti-inflammatory agents, immunostimulants and anti- cancer agents."

  • "[I]nhibit. . .inflammation and thereby prevent . . .tissue damage."

  • "[E]ffective . . . and tissue restoring agents."

  • "[P]revent cell destruction, help to build collagen and reduce possible damage due to over exposure to the sun."

C12 - C15 Alcohol Benzoate

  • "[H]elp . . . to rebuild the skin's natural lipid barrier."

Linoleic Acid Esters

  • "[P]rovides'protection to the skin from internal inflammation and help to reduce the damage inflicted by ultraviolet light and free radical formation ."

Allantoin

  • "[A]cts. . .as a . . .healing agent, it helps to restore damaged skin and to prevent additional effects of local inflammation."

Ascorbyl Palmitate

  • "[F]orm of Vitamin C . . .acts as an antioxidant and as a builder of collagen ."

Shitake Extract

  • "[A] well known immune system stimulant."

  • "[W]idely used to help restore health in a variety of illnesses."

  • "In the treatment and prevention of aging it has a powerful effect on the immune system to restore damaged tissues and to prevent further damage."

  • "Ellagi Cream'"" is an immune system stimulant, assists the body in the repair of damaged skin . . .collagen builder . . .protects from internal inflammation . . . ."

  • " Brochure: "[A]ssists the body in the repair of damaged skin . . .collagen builder. . ."

  • " Product Label: "Facelift without a knife"

Furthermore, these products are not generally recognized as safe and effective for the above referenced conditions and therefore, the products are "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 the 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.

Sunscreen Claims

The following statements are examples of claims observed in your labeling for the product Ellagi Cream related to sun protection:

Claims from website for Ellegic Acid, an ingredient in Ellagi Cream

  • "[H]elps to prevent any harmful action of the sun ."

  • "[A]cts naturally as a sunscreen and boosts the action of other sunscreens."

  • Brochure: "a SPF 30 sun block."

Based on this intended use of the product as a sunscreen, the product is a drug as defined by section 201(g) of the Act.

According to the label, this product contains, among other ingredients, "[a] proprietary Blend of Red Raspberry Extract, Octyl Methoxycinnamate, Octyl Salicylate", and it is intended for topical application. We are not aware of a product like Ellagi Cream, as formulated and labeled, being marketed as a sunscreen product in the U.S . on or before December 4, 1975, so as to qualify for evaluation under FDA's OTC Drug Review, nor are we aware that the red raspberry extract was an active sunscreen ingredient in sunscreen product marketed in the U.S. on or before December 4, 1975. Furthermore, we are not aware that red raspberry extract is generally recognized by scientific experts as safe and effective for use as an ingredient in a sunscreen product. Therefore, Ellagi Cream is a "new drug" as defined by section 201(p) of the Act. Since Eliagi Cream is not the subject of an approved new drug application, its marketing in the United States violates section 505(a) of the Act.

Registration

The FDA has determined that your facility is subject to the registration requirement in section 415 of the Act [21 U.S.C. § 350d] and FDA's implementing regulation at 21 CFR Part 1, Subpart H. During our inspection at your facility on December 2, 2004, you were advised of this requirement.' Our records indicate that, to date, your facility has not been registered with FDA. The failure to register a facility as required is a prohibited act under section 301(ddt of the Act [21 U.S.C. § 331(dd)]. Please register your facility immediately . Registration may be accomplished online at http://www.access.fda.gov. We strongly encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number. Alternatively, you may contact the FDA Industry Systems Help Desk at 1-800-216-7331 or 301-575-0156 to inquiry about mail or fax registration and related forms.

This letter is not an all-inclusive review of your websites, facility, and the products that your firm markets. It is your responsibility to ensure that all products marketed by your firm and your firm's facilities comply with the Act and its implementing regulations.

The Act authorizes injunctions against manufacturers and distributors of illegal products and seizure of such products [21 U.S .C. §§ 332 and 334] . 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.

Please advise this office, in writing, 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 . 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

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