Department of Health and Human Services' logo Department 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

CERTIFIED MAIL
RECEIPT REQUESTED

May 20, 2008

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

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

WARNING LETTER
W/L 10-08

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)

Breast Health -Breast Support Formula

Comprehensive Prostate Formula (Doctor's Best)

In list of ingredients in Comprehensive Prostate Formula:

Coral Calcium (NP)

Grape Seed Extract (GoldVitamins)

Organic Flaxseed Oil (GoldVitamins)

Immune ACE - Mega Gold Special Formulation, Cancer Care Supplement

IP-6 Inositol Hexauhosphate (Olympian Labs)

Lycozyme and Lycozyme Extra Strength

Shark Cartilage (K-Max)

Shark Cartilage (Olympian Labs)

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

This page was posted on July 19, 2010.

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