Public Health Service Food and Drug Administration
Atlanta District Office 60 8th St., NE Atlanta, GA 30309
May 22, 2013
Mr. Jay M. Connaughton, CEO
3570 Lees Chapel Road
Cedartown, GA 30125
Dear Mr. Connaughton,
On October 10, 2012, the US Food & Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing and distribution facility located at 3570 Lees Chapel Road, Cedartown, GA. This letter concerns a product (b)(4) BIOTIN 3,000 mcg. (3 mg)” that you manufacture for an own label distributor, (b)(4). As manufactured and labeled, this product is in violation of the Federal Food, Drug and Cosmetic Act (the Act).
During the inspection noted above, our Investigator collected a sample and product labeling for the (b)(4) Biotin product. Following the inspection, this product was submitted to the FDA Southeast Regional Laboratory for toxic element and nutrient analysis.
Based on our review of the laboratory analytical results and the product labeling, we have determined that your (b)(4) Biotin product is misbranded under section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labeling is false and misleading. The label for this product states that it provides 3000 mcg (3 mg)/serving (2 tablets) of biotin. However, our laboratory found the biotin content in the analyzed sample to contain 0.168 mg/serving of biotin (5.6% of declared) on the first analysis and 0.15 mg/serving of biotin (4.99% of declared) on the repeat analysis. Under Title 21, Code of Federal Regulations, Part 101, specifically 21 CFR 101.9(g)(4)(i), a food product is misbranded if the content of the added nutrient (in this case, biotin) is not at least equal to the value for the nutrient declared on the label of the product. Therefore, your product is misbranded because the label declares 3 mg/serving of biotin but our laboratory results demonstrate a lesser amount of biotin present in your product.
Furthermore, your (b)(4) Biotin product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because the label fails to bear the name of each dietary ingredient. The product also is misbranded under section 403(q)(5)(F) [21 U.S.C. § 343(q)(5)(F)] because the label fails to include the quantity of each dietary ingredient (or of a proprietary blend of such ingredients) per serving. Specifically, the nutrition information of your label declares “Minerals (as 74 minerals and trace minerals),” but does not name the minerals or their quantities per serving. If a dietary supplement product makes a claim about containing minerals or they are added for the purpose of supplementation, then each mineral must be declared in the nutrition information in accordance with 21 CFR 101.36(b).
Finally, your (b)(4) Biotin product is misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person, as described in section 761(b) of the Act [21 U.S.C. § 379aa-1(b)], may receive reports of serious adverse events associated with the product.
The violations cited in this letter are not intended to be an all inclusive list of the deficiencies in your products and their labeling or other violations that may exist at your facility. It also does not indicate that FDA has reviewed all the products you manufacture. It is your responsibility to ensure that all of your products are in compliance with the Act and applicable FDA regulations. You can find copies of the Act and regulations through links on FDA’s homepage at www.fda.gov.
You should take prompt action to correct the violations noted in this letter and to prevent these and other violations in the future. Failure to do so may result in enforcement action by FDA without further notice, including, without limitation, seizure and/or injunction.
Within fifteen (15) working days from your receipt of this letter, please notify this office in writing of the specific steps you have taken to correct the violations noted above. Include in your response documentation to show that correction has been achieved. If you cannot complete all corrections within 15 working days, please state the reason for the delay and the date by which you will complete the corrections.
Your written response should be sent to the US Food and Drug Administration, Attn: Janice L. King, Compliance Officer, at the address noted in the letterhead. If you have questions, please contact Mrs. King at 843-746-2990 or write her at the address noted in the letterhead.