Inspections, Compliance, Enforcement, and Criminal Investigations
Abbott Laboratories, Inc. 12/12/07
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
300 River Place
Detroit. MI 48207
RETURN RECEIPT REQUESTED
December 12, 2007
Miles D. White
Chairman of the Board and Chief Executive Officer
5858 Cleveland Avenue
Columbus, Ohio 43215
Dear Mr. White:
The Food and Drug Administration (FDA) collected samples of Vital HN with Partially Hydrolyzed Protein, a medical food product manufactured at Ross Products Division, Abbott Labs, 901 North Centerville Road, Sturgis, Michigan 49091-9302, during an inspection of that facility May 15-22, 2007. Our analysis shows the product to be misbranded under section 403 of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. 343]. You may find the Act and FDA's implementing regulations through links on FDA's home page at www.fda.gov.
Under the Act, a product is misbranded if its labeling is false or misleading in any particular manner [Section 403(a)(1) of the Act, 21 U.S.C. 343(a)(1)]. FDA analyzed a sample of your Vital HN with Partially Hydrolyzed Protein product for nutrient content and found that your product is misbranded because the level of vitamin K in the product is significantly less than the amount declared on the label. The labeling states that the product contains (redacted) mcg vitamin K per packet. FDA analysis revealed that the product contains (redacted) mcg vitamin K per packet (redacted) of the declared value). Because medical foods are used for the dietary management of diseases and conditions with distinctive nutritional requirements, over- and under-declaration of nutrients in medical foods are of particular concern to the FDA. Prolonged use of Vital HN may delay the blood clotting mechanism due to inadequate vitamin K intake, especially for individuals receiving anticoagulant medication (e.g;, dicoumerol, heparin).
You must immediately correct this violation. If you do not immediately correct it, you may be subject to enforcement action without further notice. The Act provides for seizure of illegal products and for injunctions against manufacturers and distributors of illegal products [21 U.S.C. 334 and 332].
In addition to the violation discussed above, we also note that the ingredient statement on the label identifies an ingredient in the product as "partially hydrolyzed soy/collagen." It is unclear whether you are using collagen, soy or a combination of collagen and soy. Title 21, Code of Federal Regulations, Section 101.4 (21 CFR 101.4) states that all ingredients must be listed by their common or usual name, in descending order of predominance by weight. You should revise your labeling to clarify the exact ingredients currently listed as "partially hydrolyzed soy/ collagen."
This letter is not an all~inclusive list of deficiencies that may exist in your product labeling. It is your responsibility as top management to ensure that your establishment is in compliance with all requirements of applicable laws and regulations.
Please advise this office in writing within fifteen (15) working days of receipt of this letter of any steps you have taken or will take to correct the noted violation and to prevent its recurrence. Include any documentation necessary to show that the corrections have been achieved. 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. Please send your reply to Attention: Judith Jankowski, Compliance Officer, Food and Drug Administration, Detroit District Office, Compliance Branch (HFR-CE750), 300 River Place, Suite 5900, Detroit, Michigan 48207. If you have any questions regarding any issue in this letter, please contact Ms. Jankowski at (303) 393-8125.
Joann M. Givens