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U.S. Department of Health and Human Services

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Enforcement Actions

H & L Worldwide Inc. 20-May-08

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

Public Health Service
Food and Drug Administration

 

Los Angeles District
19701 Fairchild
Irvine, California 92612-2506
Telephone: (949) 608-2900
FAX: (949) 608-4401


WARNING LETTER

CERTIFIED MAIL
RECEIPT REQUESTED

May 20, 2008

W/L 10-08

H&L Worldwide Inc.
2003 N. Tyler Ave.
South El Monte, CA 91733

900 S 2nd St Apt C
Alhambra, CA 91801-5911

Dear Sir or Madame:

This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address www.vitasprings.com and has determined that the products "Best Curcumin with Bioperine," "Curcumin," "Breast Health - Breast Support Formula," "Comprehensive Prostate Formula," "Coral Calcium," "Grape Seed Extract," "Organic Flaxseed Oil," "Immune Ace," "IP-6 Inositol Hexaphosphate," "Lycozyme," "Lycozyme Extra Strength," and "Shark Cartilage" are promoted for conditions that cause the 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)]. The therapeutic claims on your website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of the products with these claims violates the Act.

Examples of some of the claims observed on your website include:

Best Curcumin with Bionerine (Doctor's Best) and Curcumin (NP)

• "[B]enefits have been researched . . . . due to their possible role in . . . fighting heart disease and cancer."

• "Guarding Against Cancer - Studies point to turmeric's ability to neutralize free radicals, chemicals that could damage cells. Turmeric extract (curcumin) can ward off cancer and tumorous growths."

Breast Health -Breast Support Formula

• "[I]ncludes ingredients proven in clinical studies to aid in the prevention of breast cancer."

Comprehensive Prostate Formula (Doctor's Best)

• In list of ingredients in Comprehensive Prostate Formula:

o "Lycopene -[r]ecent research suggests that lycopene may help reduce the risk of prostate cancer."

o "Minerals - Selenium may play a role in cancer risk reduction . . . men with the highest levels of selenium were less likely to develop prostate cancer than those with the lowest selenium levels."

Coral Calcium (NP)

• "Benefits of Coral Calcium include: . . . prevent[ing] diseases such as cancer."

• "A direct correlation has been observed between illnesses such as cancer . . . and low pH (acidic)levels. . . . When coral calcium is supplemented on a daily basis, pH levels are risen naturally . . ."

• "Coral calcium may help fight cancer . . ."

Grape Seed Extract (GoldVitamins)

• "[E]ffective in reducing the risk of cancer . . ."

• "[E]ffective in promoting cytotoxicity (cell death) in the cancer cells . . ."

Organic Flaxseed Oil (GoldVitamins)

• "Another beneficial ingredient found in abundance in flax seed is lignan - a phytochemical with potential for cancer prevention."

• "A number of animal studies have shown a beneficial role of flaxseed, oil in delaying breast cancer progression and preventing against colon cancer . . . ."

• "Protects against cancer"

Immune ACE - Mega Gold Special Formulation, Cancer Care Supplement

The reference to cancer in the product name indicates that "Immune ACE - Mega Gold Special Formulation, Cancer Care Supplement" is intended for use in treating or preventing cancer.

IP-6 Inositol Hexauhosphate (Olympian Labs)

• "[Researchers] found that inositol hexaphosphate slowed or stopped the growth of liver cancer cells and shrank existing tumors three- to four-fold. Inositol hexaphosphate does not kill cancer cells - it tames them and makes them behave like normal cells. Inositol hexaphosphate decreases proliferation of cancer cells and causes them to differentiate, often reverting to the size, shape and structure of normal cells."

• "Wheatgrass may help to eliminate cancerous growths."

Lycozyme and Lycozyme Extra Strength

• "Current research suggests that lycopene's powerful antioxidant activity confers a high degree of protection against cholesterol oxidation, a process believed to influence prostate cancer."

• "[L]ycopene increases gap junctional communication between cells . . . by restoring this communication process lycopene may aid in reversing the malignant [transformation] process."

• On "Lycozyme Extra Strength" page only: "Lycopene . . . has been shown . . . to reduce the chance of developing prostate cancer."

Shark Cartilage (K-Max)

•"[E]ffective cancer treatment . . ."

•"[C]artilage apparently reduces the creation of a network of blood vessels around a tumor, and therefore prevents it from growing or spreading."

•"Shark Cartilage is also a popular alternative against cancer, taken both to slow the growth of
existing tumors and in smaller daily doses to prevent new cancers."

Shark Cartilage (Olympian Labs)

•"Shark cartilage has been used in the relief of many illnesses including cancer . . . . "

Your 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. § 32l(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section505(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. Your products, "Best Curcumin with BioPerine," "Curcumin," "Breast Health - Breast Support Formula," "Comprehensive Prostate Formula," "Coral Calcium," "Grape Seed Extract," "Organic Flaxseed Oil," "Immune Ace," "IP-6 Inositol Hexaphosphate," "Lycozyme," "Lycozyme Extra Strength," and "Shark Cartilage" are also misbranded within the meaning of section 502(f)(1) of the Act, in that labeling for these drugs fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)].

The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. While reviewing your website, we noticed that you were promoting several of the products noted above for the treatment and/or prevention of diseases other than cancer and that you were also promoting other products for disease treatment and/or prevention. The disease treatment and prevention claims on your website that cause your products to be unlawful were too numerous to list in this letter. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your website, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.

You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334].

Please notify 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. Include any documentation necessary to show that correction has been achieved . 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 written response should be sent to Pamela B. Schweikert, Director, Compliance Branch, U.S. Food and Drug Administration, Los Angeles District Office, 19701 Fairchild Road, Irvine, CA 91612. If you have any questions about this letter, please contact Compliance Officer MaryLynn Datoc at (949) 608-4428.

Sincerely,

/S/

Alonza E. Cruse
District Director
Los Angeles District

Cc:

Associate Director
Division of Advertising Practices
Federal Trade Commission
600 Pennsylvania Avenue, N.W.
Washington, D.C. 20580