Inspections, Compliance, Enforcement, and Criminal Investigations
Global Biotechnologies, Inc. 08-Feb-06
Department of Health and Human Services
Public Health Service
New England District
RETURN RECEIPT REQUESTED
February 8, 2006
Robert Bogosian, President and Owner
Global Biotechnologies, Inc.
54 York Street, Suite 1 b
Portland, ME 04101-4569
Dear Mr. Bogosian:
On November 2, 2005, an investigator from the Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing, repacking, and distribution facility located at 54 York Street, Suite 1b, Portland, Maine. During this inspection, you provided our investigator with labeling, including product labels and promotional flyers that accompany the products. FDA has reviewed your labeling, including your websites at http://www.globalbio.com and www.neistitute.com, for your products Healthy Trac™ and Immunol™, and found that they are promoted for conditions that cause them to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)]. The therapeutic claims in your products labeling 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 implementing regulations on FDA's website at http://www.fda.gov.
Specific examples of claims in your product labeling that promote your products as drugs are as follows:
Healthy Trac ™
The following two claims are made on the label for your Healthy Trac™ in your promotional flyer titled "Natural Prebiotic, Health Trac™ Dietary Supplement", and on your websites, http://www.globalbio.com and http://www.neinstitute.com, under title "Healthy Trac™" and under a picture of a bottle of your Health Trac™ product respectively:
"Lowers Cholesterol, Blood Glucose, and Insulin Levels."
"Helps reduce Cholesterol, Serum Glucose and Serum Insulin Levels, important factors for diabetics."
The following two claims are made on each of your websites, http://www.globalbio.com and http://www.neinstitute.com, under the title "Immunol™ and under a picture of a bottle of your ImmunoI™" product respectively. The same two claims are also made on your promotional flyer titled "Unleash a Disease Fighting Powehouse, Immunol™, Your Key to A Healthy Immune System".
"Mediates Activity of Autoimmune Diseases."
"An optimal immune system reduces the incidence of transient infections including influenza, SARS, the common cold, sinus and ear infections, measles, mumps, . . . and other infectious diseases. A highly activated immune system directly relates to your body's ability to purge rogue cells that are the precursors to cancer. . . . With the addition of ImmunoI™ to your diet, the numbers and activity level of the immune system cells responsible for optimal health will increase. Remember, 80% of all cancers are thought to be cause [sic] by preventable factors, including a good immune system; only 20% of cancers have genetic roots.
Your products are not generally recognized as safe and effective for the above referenced conditions and, therefore, these products are also new drugs under section 201(p) of the Act [U.S.C. 321(p)]. New drugs may not be legally marketed in the United States without prior approval from 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 sponsors to demonstrate that the drug safe and effective.
In addition, your products are misbranded under section 501(f)(1) of the Act [21 U.S.C. 321(f)(1)] in that labeling for these drugs fails to bear adequate directions for use.
Please notify this office in writing within fifteen (15) working days of receipt of this letter as to the specific action you have taken or intend to take to correct these violations and an explanation of each step taken to assure that similar violations do not recur. If corrective action cannot be completed within fifteen days, please include in your reply the reason for the delay, the time within which the corrections will be completed, and any documentation necessary to indicate correction has been achieved.
In addition to the violations described above, FDA is concerned that the statement "FDA approved as a food additive" on the product label for your product Healthy Trac™ may mislead consumers about the regulatory status of your product. As described in section 409(c)(1)(A) of the [21 U.S.C. 348(c)(1)(A)], FDA approves a food additive by issuing a regulation prescribing, with respect to specific proposed uses of the food additive, the conditions under which such additive may be safety used. As part of FDA's scientific review during the food additive approval process, the agency evaluates safety data pertaining to the proposed uses of the additives and data on the "physical or other technical effect" the additive is intended to produce (see 21 U.S.C. 348(b)(2), (c)(4)). The sole ingredient identified on your product label is Arabinogalactan. Arabinogalactan is an approved food additive for only the following uses, as prescribed by regulation: as an adjuvant in microcapsules for flavoring substances, as defined in 21 CFR 172.230, and as an emulsifier, stabilizer, binder or bodying agent in essential oils, nonnutritive sweeteners, flavor bases, non-standardized dressings, and pudding mixes (21 CFR 172.610). FDA has not reviewed and made a determination on the safety of arabinogalactan for consumption as a single-ingredient product, nor has the agency evaluated whether arabinogalactan has the health effects described in your labeling for Healthy Trac™. We are concerned that the label statement "FDA approved as a food additive" may mislead consumers to believe that FDA's approval of arabinogalactan as a food additive to produce technical effects in certain foods is a government endorsement of the safety and/or usefulness of your product for the very different health-related purposes recommended in the labeling of Healthy Trac™.
This letter is not intended to be an all-inclusive review of your products and their labeling. You should review the labeling for all of your products to ensure that they comply with the applicable requirements of the Act and implementing regulations. Failure to do so may result in regulatory action without further notice, such as seizure and/or injunction.
Your reply should be directed to Ann Simoneau, Compliance Officer, at the above address.
Gail T. Costello, Director
New England District Office