Inspections, Compliance, Enforcement, and Criminal Investigations
ForMor, Inc. d/b/a ForMor International 12/21/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
4040 North Central Expressway
Dallas, Texas 75204-3128
December 21, 2012
Sent via UPS Overnight
Stanley D. Goss, CEO and Owner
ForMor Inc, d/b/a ForMor International
496 Highway 64 East
Conway, Arkansas 72032
Dear Mr. Goss:
On March 30 through April 4, 2012, the U,S, Food and Drug Administration (FDA) inspected your firm located at 496 Highway 64 East, Conway, Arkansas. During the inspection, our investigator was informed that your firm has entered into agreements with other manufacturers to manufacture your dietary supplement products under your firm's name, You also informed our investigator that you approve the final design and content found on the labels of your dietary supplement products. To the extent that you contract with another manufacturer to manufacture dietary supplements for you, that your firm labels, holds, and then releases for distribution under your firm's name, you have an obligation to know what and how manufacturing activities are performed so that you can make decisions related to whether the packaged and labeled product conforms to its established specifications and whether to approve and release the product for distribution, even though you have hired another person to perform manufacturing operations on your behalf [See 72 Fed, Reg 34752, 34790 (June 25, 2007)].
Our investigator found a number of serious violations of the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). As a result, your Cardio Cocktail and Argenix dietary supplement products are adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)], in that they have been prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements in 21 CFR Part 111.
In addition, we have reviewed the labels for your products and your website at www.formor.com. Based on our review, we have concluded that your Calm Cocktail product is promoted for conditions that cause the product to be a drug under section 201 (g)(1)(B) of the Act [21 U.S.C. § 321 (g)(1)(B)]. The therapeutic claims on your website establish that your Calm Cocktail product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease in humans. The marketing of your product with these claims violates the Act.
You may find the Act and FDA's regulations through links in FDA's home page at www.fda.gov.
Dietary Supplement CGMP Violations
During the inspection, you informed our investigator that you strictly rely on your manufacturers to fully establish and create all procedures, processes, and controls in regards to the labeling of your finished dietary supplement products. However, you also informed our investigator that you approve the final design and content found on the labels of your dietary supplement products before the labels are sent from the label printers to the firm that labels your products on your behalf. As such, we consider you to be performing labeling operations since you exercise control and oversight over the labels, even though you have hired another firm to label your dietary supplement products for you. You must therefore comply with the dietary supplement CGMP regulations related to your labeling operations.
We found the following dietary supplement CGMP violations related to your labeling operations:
1. You failed to implement a system of production and process controls that covers all stages of manufacturing, packaging, labeling, and holding of dietary supplement to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.55. Specifically, you do not have a system of production and process controls to ensure that your dietary supplement products are labeled as specified in the master manufacturing record.
2. You failed to establish the following specifications related to labeling:
• You failed to establish a specification for any point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.70(a).
• You failed to establish specifications for dietary supplement labels (label specifications), as required by 21 CFR 111.70(d).
• You failed to establish specifications for the labeling of the finished packaged and labeled dietary supplements, including specifications that ensure that you applied the specified label, as required by 21 CFR 111.70(g).
3. Your quality control personnel failed to ensure that your manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.105. Specifically, your quality control personnel have failed to perform the following operations related to your labeling operations:
• Conduct operations for labels before use in the manufacture of a dietary supplement [21 CFR 111.120], including reviewing all receiving records for labels [21 CFR 111.120(a)]
• Review and approve all master manufacturing records and all modifications to the master manufacturing records [21 CFR 111.123(a)(1)] for your labeling operations, and review and approve all batch production records [21 CFR 111.123(a)(2)] for your labeling operations.
• Perform quality control operations for labeling operations [21 CFR 111.127], including reviewing and approving all records for label operations [21 CFR 111.127(c)].
• Make and keep the records required under 21 CFR Part 111, Subpart F in accordance with 21 CFR Part 111, Subpart P [21 CFR 111.140].
We received your written response dated April 25, 2012, which was made on your behalf by Dennis M. Gronek, Gronek & Associates, Attorneys at Law, Chicago, Illinois, and have found it to be inadequate because it does not address the labeling operations you perform. Your written response states that you are responsible for complying with only those CGMP regulations for dietary supplements that apply to holding and distributing finished dietary supplement products because you are solely a holder and distributor of dietary supplement products. However, we also consider your firm to be a labeler of your dietary supplement products, even though you have hired another firm to label your products for you, because you approve the final design and content found on the labels of your dietary supplement products and send the approved labels to the firm that you have hired to label your products for you. As such, you must comply with the dietary supplement CGMP regulations related to your labeling operations,
Unapproved New Drugs
An example of the claims found on your website include:
Calm Cocktail webpage:
• "A study from the Agency for Healthcare Research and Quality stated that Melatonin [an ingredient in your product] decreased sleep onset latency in people with a primary sleep disorder."
Because your Calm Cocktail product is not generally recognized as safe and effective for the above referenced use, the product is a "new drug" under section 201(p) of the Act [21 U.S.C. § 321 (p)], A new drug 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 sponsor to demonstrate that the drug is safe and effective.
Further, your Calm Cocktail product is offered for a condition that is not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use this drug safely for its intended use, Thus, your product is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] in that its labeling fails to bear adequate directions for its intended use, The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
The above violations are not meant to be an all-inclusive list of the violations at your facility or that exist in connection with your products or their labeling, You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations, It is your responsibility to ensure that your firm and your products comply with the Act and its implementing regulations.
You should take prompt action to correct these violations, Failure to promptly correct the violations cited above may result in enforcement actions without further notice, Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products, Please respond to this letter in writing within fifteen (15) working days from your receipt of this letter, Your response should outline the specific steps you have taken to correct the violations cited above and to ensure that similar violations do not occur. Your response should include any documentation necessary to show that correction has been achieved, If you cannot complete all corrections before you respond, state the reason for the delay and the date by which you will complete the corrections.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31 (a)(2)(B)). FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please send your reply to the Food and Drug Administration, Attention: Elvia J. Cervantes, Compliance Officer, at the above letterhead address. If you have any questions regarding any issue in this letter, please contact Ms. Cervantes at 214-253-5236.
Reynaldo R. Rodriguez, Jr.
Dallas District Director