Inspections, Compliance, Enforcement, and Criminal Investigations

Rocky Fork Formulas Inc 5/13/16

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2775

 

Via UPS
 
 
May 13 , 2016
 
Mr. Charles S. Michaelis, President
Rocky Fork Formulas, Inc.
528 Leacrest Place W
Westerville, Ohio 43081-3062
 
Warning Letter
CIN-16-482880-14
 
 
Dear Mr. Michaelis:
 
The United States Food & Drug Administration (FDA) conducted an inspection at your dietary supplement firm, Rocky Road Formulas, located at 528 Leacrest Place W., Westerville, OH on May 22, May 28, July 8 and August 27, 2015. Based on the inspection, a review of the product labels collected during the inspection, and a review of your website at https://www.rockyforkformulas.com, we have identified serious violations of the Federal Food, Drug and Cosmetic Act (the Act) and applicable regulations. You may find the Act and the FDA’s regulations through links on FDA’s home page at www.fda.gov
 
We received your written response letters on July 23, 2015 to the 483 issued on July 8, 2015.  We have reviewed your response, and we address your proposed corrective actions below.
 
Unapproved New Drugs/Misbranded Drugs
 
The FDA reviewed your website at the Internet address https://www.rockyforkformulas.com in March 2016 and has determined that you take orders there for the products Angio Fin, Arthritis Complex HS, EPA 1000, Gluco-Poise, Liver Complex, Niacin 500 Time-Released, Prostate Complex HS, Univase, Virex Complex. The claims on your websites establish that the products are 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)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. 
 
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
 
ADRENAL COMPLEX HS
  • Adrenal dysfunction is considered the number one problem they encounter in their patients by many holistic practitioners…Allergies are one of the most widely felt consequences. Others include; Low back pain, headaches…both low and high blood pressure, hypoglycemia, night blindness…to name just a few things seen in adrenal insufficiency.”
ANGIO FIN
  • “It is an excellent source for the glucosamine sulfate and chondroitin sulfate that are commonly used in rebuilding arthritic joints…It is also used in conditions that involve angiogenesis. This includes “wet” macular degeneration. There is currently a study being performed to determine its effectiveness in tumor growth.”
ARTHRITIS COMPLEX HS
  • “Arthritis Complex HS also contains anti‐inflammatory herbs Boswellia serrata and Turmeric and even MSM…Arthritis Complex also contains a powerful fatty acid‐ CMO ‐Cetyl Myristoleate, used to help rebuild damaged cartilage in both Rheumatoid and osteo arthritis.”
  • The name of your product is a drug claim. 
EPA 1000
  • “These oils have been cited in numerous studies as being an important factor in preventing heart and coronary disease.” 
GLUCO-POISE
  • “This formulation was designed through researching ingredients that are most commonly used by nutritional practitioners who are working with patients who have both low blood sugar and diabetes. The formula created is a unique and powerful tool for use in controlling blood sugar.” 
LIVER COMPLEX
  • “Milk Thistle has been shown to be effective in numerous studies to aid cirrhosis.” 
NIACIN 500 TIMED-RELEASE
  • “Niacin lowers cholesterol…and has also been used to alleviate joint pain.” 
PROSTATE COMPLEX HS
  • “There has been quite a bit of publicity lately in regards to the use of saw palmetto berries for those who suffer with Benign Prostatic Hyperplasia (or prostatic hypertrophy). This involves the swelling of the prostate and the discomfort of frequent urination especially at night. Prostate Complex not only utilizes a high potency dose of saw palmetto…”
UNIVASE
  • “[A]s a nutritional approach to such disorders as, but not limited to: degenerative diseases, heart disease, arteriosclerosis…inflammations, and disorders involving inflammations (‐itis at the end of a word generally indicates inflammation; i.e. arthritis, pancreatitis, diverticulitis, etc.)”
VIREX COMPLEX
  • “Many report that nothing beats zinc to fight the common cold, while others swear that grapefruit seed extract is the best. Yet others insist that Echinacea is the only way to go. Now you no longer have to guess which is the best. After extensive research we have placed all of these ingredients into one powerful formula that supplies grapefruit seed extract, zinc and Echinacea in a single capsule.”
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. § 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. 
 
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353 § (b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
 
Your products Adrenal Complex HS, Angio Fin, EPA 1000, Gluco-Poise, Prostate Complex HS, and Univase are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, Angio Fin, EPA 100, Gluco-Poise, Prostate Complex HS, and Univase fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)].
 
Your response indicates that your firm is currently researching name changes for some of your dietary supplements. However, your response is inadequate, because your products continue to be marketed as unapproved new drugs and a violation of the Act. 
 
Adulterated Dietary Supplements
 
Even if your dietary supplements were not unapproved new drugs, they would still be adulterated dietary supplements under section 402(g)(1) of the Act. The inspection revealed significant violations of the CGMP requirements for dietary supplements. These violations cause your dietary supplement products to be adulterated under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed or held under conditions which do not meet the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). 
 
Specifically, our investigator observed the following significant violations:
 
1.    You failed to establish specifications that provide sufficient assurance that the products you receive from a supplier for packaging or labeling as dietary supplements (and for distribution rather than for return to the supplier) are adequately identified and are consistent with your purchase orders, specifically, for those products purchased from SGT, NOW Foods and GRL that are formulated by those manufacturers, as required by 21 CFR 111.70(f).
 
Additionally, your response states that you have always had product specifications; however, you were unable to provide your product specifications during the inspection, nor were the specifications provided in your response, therefore we are unable to verify the adequacy of your response.
 
Once your have established specifications for products that you receive from a supplier for packaging or labeling as dietary supplements, you must verify that the specifications are met in accordance with 21 CFR 111.165(b) and 21 CFR 111.165(c), and you must make and keep records of such specification in accordance with 21 CFR 111.95(b)(1).
 
2.    Your firm failed to establish a system of production and process controls and implement quality control operations to ensure the quality of your dietary supplements and that the dietary supplements are packaged and labeled as specified in the master manufacturing record as required by 21 CFR 111.65. Specifically, you do not have any quality control operations to oversee the packaging and holdings of your dietary supplements that are contract manufactured for your firm. Furthermore, you failed to establish and follow written procedures for the responsibility of quality control operations, including written procedures for conducting a material review and making a disposition decision, as required by 21 CFR 111.103.
 
Your response states you are currently developing a more stringent program to oversee and certify GMP practices. We are unable to evaluate the adequacy of your response because you did not provide written documentation showing how you plan to implement your quality control operations.
 
3.    You failed to establish and follow written procedures for packaging and labeling operations, as required by 21 CFR 111.403. You must also make and keep records of the written procedures for packaging and labeling operations, as required by 21 CFR 111.430(b). Specifically, during the inspection our investigator found your firm failed to have written procedures to document the labeling operations performed at your firm for dietary supplements marketed under the brands ''Rainrock Nutritionals" and “Rocky Fork Formulas.”
 
Your response states you have a procedure for product labeling but are developing a more stringent procedure for labeling unlabeled products. We are unable to evaluate the adequacy of your response because you did not provide written documentation showing how you plan to implement your packaging and labeling operations.
 
4.    You failed to establish and follow written procedures to fulfill the requirements related to product complaints, as required by 21 CFR 111.553. Specifically, our investigators found that your firm failed to have written procedures to review customer complaints for dietary supplement products distributed by your firm. 
 
Your response states you are developing a written procedure and appropriate forms for maintaining records of complaint. We are unable to evaluate the adequacy of your response because you did not provide written documentation showing how you plan to document and investigate product complaints. 
 
5.    Your firm failed to establish and follow written procedures to fulfill the requirements related to returned dietary supplements, as required by 21 CFR 111.503. Specifically, our investigators found that your firm failed to have a written procedure to review returned dietary supplement products distributed by your firm. 
 
Your response indicated that you have had an unwritten return policy for many years. We are unable to evaluate the adequacy of your response because you failed to provide documentation of an established returned products procedure.
 
6.    Your firm failed to collect and hold reserve samples of each lot of packaged and labeled dietary supplements that you distribute, as required by 21 CFR 111.83(a). Specifically, you do not collect and hold reserve samples of any of the dietary supplements that you distribute. You must collect and hold the required reserve samples in accordance with the requirements set forth in 21 CFR 111.83(b).
 
Your response indicated that you have implemented an interim policy for keeping reserve samples. We are unable to evaluate the adequacy of your response because you failed to provide documentation of your interim policy for keeping reserve samples.
 
Misbranding Dietary Supplements
 
Furthermore, based on labeling collected during the inspection of your firm, we note that several of your products are misbranded under multiple sections of 403 of the Act, as follows:
 
1.    Your Allerform Allergy Relief, Arthrite, Arthritis Complex HS, Fibromalate, and Fibromyalgia Complex products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343 (i)(2)] in that the product label fails to declare the common or usual name of each ingredient used as required by 21 CFR 101.4(a), 21 CFR 101.4(g) and 21 CFR 101.4(h). For example:
  • Your Fibromyalgia Complex and Depression Complex products are in the form of capsules, but the label fails to declare capsule ingredients.
  • Your Fibromalate, Fibromyalgia Complex, Arthritis Complex HS and Arthrite product labels declare the dietary ingredient MSM, but this is not the common or usual name for this dietary ingredient.
  • Your Allergy Relief and Allerform product labels do not identify the species which are the sources of the omega-3 fish oil nor the sources of the lyophilized adrenal, pituitary, liver and parathyroid dietary ingredients.
2.    Your Allerform, Allergy Relief, Arthrite, Arthritis Complex HS and Fibromalate, Vitamin B-15 products are misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343 (q)(1)(A)], because the serving size declared on the labels is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. For example, your Vitamin B-15 and Fibromalate product label directions of use suggest the consumer takes one or two capsules, but the serving size lists 1 capsule.
 
3.    Your Andepress, Allergy Relief, Allerform, Fibromalate, Arthrite, Arthritis Complex HS, Fibromyalgia Complex and Depression Complex products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343 (q)(5)(F)] in that the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. For example:
  • The following products list vitamins and/or minerals in the incorrect order and not in accordance with 21 CFR 101.36(b)(2)(i)(B): Andepress, Allergy Relief, Allerform, Fibromalate, Arthrite, Arthritis Complex HS, Fibromyalgia Complex and Depression Complex.
  • All (b)(2)-dietary ingredients must be listed above the (b)(3)-dietary ingredients, and separated by a heavy bar, in accordance with 101.36(e)(6).
  • Your Fibromalate, Andepress, Depression Complex, Fibromyalgia Complex, Allergy Relief and Allerform product labels do not identify the sources of all dietary ingredients in accordance with 21 CFR 101.36(d).
  • Your Arthrite, Arthritis Complex HS and Fibromyalgia Complex product labels do not state the percent Daily Value for the (b)(2)-dietary ingredient manganese in accordance with 21 CFR 101.36(b)(2)(iii).
  • Your Fibromyalgia Complex and Depression Complex product labels declare a quantitative amount of zero for (b)(2)-dietary ingredients sodium, total carbohydrate and protein and fail to comply with 21 CFR 101.36(b)(2)(i). Specifically, the (b)(2)-dietary ingredients shall not be declared if they are present in amounts that can be declared as zero in accordance with 21 CFR 101.9(c).
  • Your Fibromalate product label bears an incorrect percent Daily Value for chromium based on the listed amount, in accordance with 21 CFR 101.36(b)(2)(iii)(B).
4.    Your Allerform, Allergy Relief, Andepress, Arthrite, Arthritis Complex HS, Fibromalate, and Vitamin B-15 products are misbranded within the meaning of section 403(r)(6)(C) of the Act [21 U.S.C. § 343(r)(6)(C)] because the labels appear to contain a disclaimer statement that is similar to the FDA disclaimer that is required with respect to structure function claims. The label disclaimer statement is not in compliance with the required wording and format as required in 21 CFR 101.93(c). We also note that product labels for product names that imply a structure function claim are required to contain the disclaimer statement per 21 CFR 101.93.
 
5.    Your Allerform and Allergy Relief products are misbranded within the meaning of sections 403(q)(5)(F) and 403(s)(2)(A) of the FD&C Act [21 U.S.C. §§ 343(q)(5)(F) and 343(s)(2)(A)] in that the labels fail to list the name of each ingredient of the supplement that is described in section 201(ff) and the quantity of each such ingredient. For example, your labeling contains ingredient information to suggest that your product contains amino acids. You do not list the names of the specific amino acids in the Supplement Facts panel in accordance with 21 CFR 101.36(b)(3) and 101.4.
 
6.    Your Vitamin B-15, Arthritis Complex HS, Fibromyalgia Complex, Allerform, Depression Complex, Arthrite, Fibromalate, Allergy Relief, Andepress products are misbranded within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because the labels fail to include a statement of identity as a “dietary supplement” as required by 21 CFR 101.3(g).

7.    Your Andepress, Arthrite, Arthritis Complex HS, Depression Complex, Fibromalate and Fibromyalgia Complex products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). For example, your Andepress and Depression Complex labels fail to include the part of the plant from which St. John’s wort is derived.
 
8.    Your Depression Complex and Fibromyalgia Complex products are misbranded within the meaning of 403(y) of the Act [21 U.S.C. § 343(y)] because the labels fail to include a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplements. “Domestic address or domestic phone number” means a complete address or phone number. The labels for these two products do not include complete addresses or phone numbers.
 
This letter nor the FDA 483 are intended to be an all-inclusive list of the violations that may exist at your facility and with your products, labels, and labeling. It also does not indicate that FDA has conducted an all-inclusive review of all the products you manufacture and distribute. It is your responsibility to ensure the products you manufacture and distribute are in compliance with all applicable statutes and regulations, including the Act, the CGMP regulations for dietary supplements (21 CFR Part 111), and all applicable FDA labeling regulations.
 
You should take prompt action to correct all of the violations noted in this letter and establish and implement procedures that will prevent these and other violations in the future. Failure to implement lasting corrective actions may result in FDA taking regulatory action, such as seizure or injunction, without further notice.
 
We also note the following:
  • Your Allerform, Allergy Relief, Andepress, Arthrite, Arthritis Complex HS, Depression Complex, Fibromalate, Fibromyalgia Complex, and Vitamin B-15 product labels bear the statement “based on a 2,000 calorie diet.” This statement is only permitted when the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein as required by 21 CFR 101.9(c) and 21 CFR 101.36(b)(2)(iii)(D). None of those dietary ingredients is present in amounts allowed to be declared on the label, so the statement is not permitted.
  • Your Allerform Allergy Relief, Andepress, Arthrite, Arthritis Complex HS, Depression Complex, Fibromalate, Fibromyalgia Complex, and Vitamin B-15 product labels bear the statement “RDA has not been established” or “RDI not established.” The correct statement is “DV has not been established,” “Daily Value not established,” or similar wording.
  • Your Allerform, Allergy Relief, Andepress, Arthrite,, Arthritis Complex HS, Fibromalate, and Vitamin B15 product labels bear the title “Also Contains.” The correct title of the ingredient statement is “Other ingredients” (to be used if some source ingredients are listed in the Supplement Facts) or “Ingredients” in accordance with 21 CFR 101.4(g).
  • Your Andepress product label bears an incorrect spelling for folic acid. 
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 reinspection-related costs. A reinspection 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 determining whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the re-inspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-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 reinspection-related costs.
 
Please respond to this office in writing within fifteen (15) working days from your receipt of this letter.  In your response, identify the steps you have taken or will take to correct the above noted violations and prevent similar ones. In your response, please include the timeframe in which the corrections will be completed and provide any documentation that will effectively assist us in evaluating whether the corrective actions have been made and the adequacy of such. If you are unable to complete the corrective actions within fifteen (15) working days, identify the reason for the delay and the time within which you will complete the corrections.
 
Your written response should be sent to the U.S. Food and Drug Administration, Allison C. Hunter, Compliance Officer, at the address noted in the letterhead. If you have questions, please contact Compliance Officer Hunter at (513) 679-2700 ext. 2134 or by email at allison.hunter@fda.hhs.gov
 
Sincerely,
/S/
Steven B. Barber
District Director
Cincinnati District
  

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