Inspections, Compliance, Enforcement, and Criminal Investigations
BioZeal LLC dba ChildLife Essentials 20-May-03
Department of Health and Human Services
Public Health Service
19900 MacArthur Blvd., Ste 300
RETURN RECEIPT REQUESTED
May 20, 2003
Dr. Murray C. Clarke, Owner
BioZeal LLC dba ChildLife Essentials
3051 Glencoe Avenue, #11
Marina del Rey, California 90292
Dear Dr. Murray:
This letter is in reference to the First Defense, Echinacea, Vitamin C, and Colostrum with Probiotics products marketed by your firm under the ChildLife Essentials brand name.
Between January 23rd and 29 , 2003, a representative of the Food and Drug Administration inspected your firm and collected product labeling. We have reviewed your labeling, including statements on your web site, www.childlife.net, and found that the labeling bears claims that represent that some of your products are intended for use in the cure, mitigation, treatment, or prevention of diseases. Under the Federal Food, Drug, and Cosmetic Act (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]. The claims that you are making for your First Defense, Echinacea, and Vitamin C products cause them to be drugs as described in this section of the Act. For example:
• Product label:
o recommends daily use " . . .at the first sign of infection, cold, cough or flu . . ." ; and
o represents the product to be "Immune Support for Infections, Colds, Coughs & Flu".
• Product sales sheets distributed with the product
o". . .can be used at the first sign of any acute symptom or susceptibility to infection. . . "
o". . .for use at the first sign of any cold, cough, flu or infection."
• Product sales sheet
o". . .encourages the production and release of the body's own white blood cells, the immune cells, to respond quickly and effectively to infection by both bacteria and viruses."
o"Periodic use throughout the year may provide extra protection, and use at full suggested dosages during colds and flus."
o Echinacea "is known to enhance the production and release of the body's own white blood cells, the immune cells . This encourages a quick and effective response to both bacterial and viral infections."
o". . .can provide extra support at the first sign of colds, flus, sore throats, upper respiratory symptoms, sinusitis, and ear infections."
• Product sales sheet
o ". . .may provide protection against acute infection and help reduce susceptibility to recurrent colds, flus and allergies."
o"Daily use may provide protection against acute infection and help reduce susceptibility to recurrent colds; flus and allergies."
Because your 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. Under section 505 of the Act, a new drug may not be legally marketed in the United States without an approved New Drug Application (NDA).
Your Colostrum with Probiotics is misbranded under sections 403(i)(2) and 403(q)(5)(F) of the Act because its ingredients are not declared in accordance with applicable regulations.
The amount of the dietary ingredient Bifidobacterium Bifzdum per serving is declared as "°0.5 billion," but is not expressed as an amount by weight using metric measures in appropriate units, as required by 21 CFR 101.36(b)(3)(ii)(A).
The ingredient statement lists Energy Smart ®, which is not a common or usual ingredient name as required by 21 CFR 101.4(a)(1).
Section 301 of the Act prohibits the introduction or delivery for introduction of unapproved new drugs and misbranded dietary supplements into interstate commerce.
The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that all of your products are in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct these deviations and prevent their future recurrence. Failure to make prompt corrections could result in regulatory action without further notice. Possible actions include seizure and/or injunction.
We also note that the ingredient statements of your Echinacea and First Defense products declare the presence of the botanical Stevia; however, the formulation of ingredients sheets for these products do not list Stevia among the ingredients in the products. If the products do not contain Stevia, the labels should be revised so that Stevia does not appear as an ingredient.
You should notify this office within fifteen (15) working days of the receipt of this letter of the specific steps you have taken to correct the violations noted above, including an explanation of each step taken to prevent the recurrence of similar violations. If corrective actions cannot be completed within fifteen (15) working days, state the reason for the delay and the time within
which the corrections will be completed.
Your written reply should be addressed to:
Scott Goff, Acting Director of Compliance
U.S, Food and Drug Administration
19900 MacArthur Boulevard, Suite 300
Irvine, CA 92612