Inspections, Compliance, Enforcement, and Criminal Investigations

Dandy Day Corporation 12/17/14

  

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

Public Health Service
Food and Drug Administration
 Denver District Office
Building 20-Denver Federal Center
P.O. Box 25087
Denver, Colorado 80225-0087
TELEPHONE: 303-236-3000 

 

December 17, 2014
 
 WARNING LETTER
 
 
VIA UPS PRIORITY
Overnight Delivery
Return Receipt Requested
 
Karen S. Jenkins, Owner
Dandy Day Corporation
11603 Teller Street, Unit D
Broomfield, CO  80020
 
Ref #: DEN-15-04-WL
 
Dear Ms. Jenkins:
 
The U.S. Food and Drug Administration inspected your manufacturing facility located at 11603 Teller Street, Broomfield, Colorado, from April 2 through April 8, 2014.   During our inspection, we found serious violations of the Current Good Manufacturing Practice (CGMP) regulations for Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause your dietary supplement products to be 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 the dietary supplement products have been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements.
 
We also reviewed your products’ labels and your website at www.dandyday.com in December 2014. 
 
You may find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
 
The inspection and our review of your product labeling revealed the following significant violations:
 
Unapproved New Drugs
 
Based on our review of your firm’s website at the Internet address www.dandyday.com, we have determined that you take orders there for your Aloe Lip Balm, Liniment, Lotion, and New Feet cosmetic products, and your Aloe Pearl, Alfalo, Aloespring, Crave Away, Original Supreme Energy, Ener “G”, Can G, Flora G, Flora G Plus, and Garolic dietary supplement products, which the website promotes for conditions that cause the products to be drugs 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 the products are drugs 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.     
 
Your website states that all of your products contain concentrated aloe vera. Examples of some of the claims on your website, www.dandyday.com, that provide evidence that your products are intended for use as drugs, include:
     on the homepage: “[Aloe vera] has been studied for its effectiveness as an: Antibacterial, Antiviral, Antifungal, Anti-inflammatory…”
     on the “Testimonials” pages, various testimonials for specific products within the categories of Antibacterial, Antiviral, Antifungal, and Anti-inflammatory.
 
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 the FDA, as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. 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.
 
Furthermore, your Aloe Lip Balm, Liniment, Lotion, New Feet, Aloe Pearl, Alfalo, Aloespring, Crave Away, Original Supreme Energy, Ener “G”, Can G, Flora G, Flora G Plus, and Garolic products are offered for conditions that are 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 these drugs safely for their intended purposes. Thus, these drugs are misbranded within the meaning of section 502(f)(1) of the Act, in that their labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)]. 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)].
 
Dietary Supplement CGMP Violations
 
Even if your Aloe Pearl, Alfalo, Aloespring, Crave Away, Original Supreme Energy, Ener “G,” Can G, Flora G, Flora G Plus, and Garolic dietary supplement products did not have therapeutic claims which make them unapproved new and misbranded drugs, these products would be adulterated dietary supplements within the meaning of 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 that do not meet the CGMP regulations for dietary supplements.    
 
We received your written response dated April 29, 2014 to observations cited on the FDA-483 issued to you on April 8, 2014. However, your response is inadequate to address all of the violations cited in this letter.  Specific details regarding your response follow discussions of your violations below.
 
1.    Your quality control operations for product complaints failed to include reviewing and approving decisions about whether to investigate a product complaint and reviewing and approving the findings and follow-up action of any investigation performed, as required by 21 CFR 111.135.   Specifically, our investigator found that you maintain a one page complaint procedure that states, “We have a product satisfaction guarantee. If customer is not satisfied, we offer a refund or product exchange.” However, your quality control operations for product complaints must include reviewing and approving decisions about whether to investigate a product complaint and reviewing and approving the findings and follow-up action of any investigation performed, as required by 21 CFR 111.135.  
 
2.    You failed to establish specifications 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 the following specifications:
 
a)    Component specifications for each component that you use in the manufacture of a dietary supplement [21 CFR 111.70(b)]. For example, you did not establish specifications for the (b)(4) used in your Aloe Spring Concentrate dietary supplement product, lot 0214.
b)    Product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement to ensure the quality of the dietary supplement [21 CFR 111.70(e)]. Specifically, you do not have finished product specifications for any of your finished dietary supplement products.
c)    Specifications for product you receive from a supplier for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier) to provide sufficient assurance that the product you receive is adequately identified and is consistent with your purchase order [21 CFR 111.70(f)].
 
Once you have established such specifications, you must determine whether the specifications you establish under 21 CFR 111.70 are met. You must also ensure that the tests and examinations that you use to determine whether the specifications are met are appropriate, scientifically valid methods, as required by 21 CFR 111.75(h)(1), and you must make and keep records, as required by 21 CFR 111.95. 
 
We received your written response dated April 29, 2014, which indicates that you have established specifications for your Aloe Spring dietary supplement product. However, your written response does not appear to include documentation of such specifications and we are therefore unable to verify the adequacy of your proposed corrective actions. 
 
3.    Your master manufacturing records (MMRs) fail to include all the information required by 21 CFR 111.210. Specifically, the following information required by 21 CFR 111.210 is not included in the master manufacturing record for your Aloe Spring Concentrate dietary supplement product, lots 0214 and 0713:
 
a)    A statement of any intentional overage amount of a dietary ingredient [21 CFR 111.210(e)];
b)    A statement of theoretical yield of a manufactured dietary supplement expected at each point, step, or stage of the manufacturing process where control is needed to ensure the quality of the dietary supplement [21 CFR 111.210(f)];
c)    A description of the packaging and a representative label, or a cross-reference to the physical location of the actual or representative label [21 CFR 111.210(g)]; and,
d)    Written instructions, including the following:
 
1)    Specifications for each 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 [21 CFR 111.210(h)(1)];
2)    Procedures for sampling and a cross-reference to procedures for tests or examinations [21 CFR 111.210(h)(2)];
3)    Special notations and precautions to be followed [21 CFR 111.210(h)(4)]; and,
4)    Corrective action plans for use when a specification is not met [21 CFR 111.210(h)(5)].
 
We received your written response dated April 29, 2014, which includes your revised MMR’s, which also appear to be your Batch Production Records.  Your revised MMR for your Aloe Spring Concentrate dietary supplement does not include all of the information required by 21 CFR 111.210, including the specific information listed above. For example, (b)(4) process (b)(4), your revised MMR includes instructions for a (b)(4), and other ingredients. These instructions do not include the results of the (b)(4) that need to be obtained or instructions on what to do in the event that such results are not obtained. Your MMR must include specifications for each 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 MMR, as required by 21 CFR 111.210(h)(1).  Additionally, your revised MMR for your Aloe Spring Concentrate dietary supplement fails to include a statement of any intentional overage amount of a dietary ingredient, as required by 21 CFR 111.210(e).
 
4.    Your batch production records (BPRs) do not contain all of the information required by 21 CFR 111.260. Specifically, your batch production record for your Aloe Spring Concentrate dietary supplement, lot 0214, does not include the following information required by 21 CFR 111.260:
 
a)    The results of any testing or examination performed during the batch production, or a cross-reference to such results [21 CFR 111.260(h)].
b)    A statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing [21 CFR 111.260(f)].
c)    Documentation that the finished dietary supplement meets specifications established in accordance with 21 CFR 111.70(e) and (g) [21 CFR 111.260(i)].
d)    Documentation, at the time of performance, of packaging and labeling operations [21 CFR 111.260(k)], including the results of any tests or examinations conducted on packaged and labeled dietary supplements (including repackaged or relabeled dietary supplements), or a cross-reference to the physical location of such results, as required by 21 CFR 111.260(k)(3).
e)    Documentation at the time of performance that quality control personnel reviewed the batch production record, including:
 
1)    Review of any monitoring operations [21 CFR 111.260(l)(1)(i)];
2)    Review of the results of any tests and examinations, including tests and examinations conducted on components, in-process materials, finished batches of dietary supplements, and packaged and labeled dietary supplements [21 CFR 111.260(l)(1)(ii);
 
f)    Documentation at the time of performance that quality control personnel approved and released, or rejected,  the packaged and labeled dietary supplement, including any repackaged or relabeled dietary supplement [21 CFR 111.260(l)(4)].
 
We received your written response dated April 29, 2014, which includes some examples of your revised master manufacturing records and/or batch production records (BPRs) for your Aloe Spring Concentrate, Flora G, and Aloe Pearl dietary supplement products (draft copy). While it appears you have taken some steps to include more information in your batch production records, you are still missing information required by 21 CFR 111.260. For example, the batch production record for your Flora G dietary supplement product that you included with your written response contains a label within the BPR, but the BPR examples you provided for your Aloe Spring and Aloe Pearl dietary supplement products do not include an actual or representative label for the products or a cross-reference to the physical location of the actual or representative label specified in the master manufacturing record, as required by 21 CFR 111.260(k)(2). In addition, the revised copies of your batch production records still fail to include a statement of the actual yield and a statement of the percentage of the theoretical yield at appropriate phases of processing, as required by 21 CFR 111.260(f); documentation of results of any testing or examinations conducted on packaged and labeled dietary supplement products (including repackaged or relabeled dietary supplements), or a cross-reference to the physical location of such results, as required by 21 CFR 111.260(k)(3); and documentation at the time of performance that quality control personnel reviewed any monitoring operations, the results of any tests and examinations conducted on finished batches of dietary supplement products, and approved and released, rejected, the batch for distribution, including any reprocessed batch, as required by 21 CFR 111.260(l).
 
Misbranded Dietary Supplements
 
1.    Your Aloe Spring, Aloe Quench, Original Supreme Energy, Alfalo, Ener “G”, Garolic, Aloe Pearl, and Aloe Mend Aloe Oil dietary supplement products are misbranded within the meaning of section 403(i)(2) of the Act in that the product labels fail to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(a) and (g). Specifically:
  • Your Aloe Spring and Aloe Quench products are misbranded because the labels claim it is a “Concentrated Aloe Formula”, but your label fails to declare aloe vera as a dietary ingredient;
  • Your Original Supreme Energy, Alfalo, Ener “G”, and Garolic products are misbranded because their labels lack an “Other ingredients” statement and fails to declare the capsule ingredients; and,
  • Your Aloe Pearl and Aloe Mend Aloe Oil products are misbranded because their labels fail to declare the softgel ingredients.
2.    Your Flora G, Alfalo, Ener “G”, Garolic, and Flora G Plus products are misbranded within the meaning of section 403(q)(1)(A) because the serving size declared on the label 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. Specifically:
  • Your Flora G and Flora G Plus products state to “take 1 or 2 capsules daily,” but the serving size lists 1 Veggie Capsule. The serving size should be 2 Veggie Capsules.
  • Your Alfalo, Ener “G”, and Garolic products state to “[t]ake 2-8 capsules daily,” but the serving size lists 2 capsules. If the intent is for the consumer to take 2 capsules up to 4 times per day, that should be stated clearly on the label. If the intent is that the consumer take up to 8 capsules at one time, the serving size should state 8 capsules.
3.    Your Original Supreme Energy product is misbranded within the meaning of section 403(q)(1)(B) because the label fails to list the servings per container under the serving size on the left hand side of the nutrition label or fails to include this information as part of the net quantity of contents declaration in accordance with 21 CFR 101.36(b)(1)(ii).
 
4.    Your Original Supreme Energy, Aloe Mend Aloe Oil, Aloe Pearl, Alfalo, Ener “G”, Garolic, Aloe Spring, and Aloe Quench products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)].  Specifically:
  • Your Original Supreme Energy product doesn’t list the quantity of the proprietary blend per serving as required by 21 CFR 101.36(c)(3);
  • Your Aloe Mend Aloe Oil, Aloe Pearl, Alfalo, Ener “G”, and Garolic products bear Supplement Facts panels that are not formatted as required by 21 CFR 101.36(b) in that they do not list their dietary ingredient(s) within the Facts panel;
  • Your Aloe Spring and Aloe Quench products have incorrectly calculated the percent Daily Value for (b)(2) dietary ingredients, for example, Vitamin C and Calcium, must be calculated as defined in 21 CFR 101.36(b)(2)(iii)(B); and,
  • Your Aloe Pearl and Aloe Mend Aloe Oil dietary supplement products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because they are dietary supplements but their label reflects the term “Nutrition Facts” panel rather than a “Supplement Facts” panel as required by 21 CFR 101.36(e)(1).
 
The above violations are not intended 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 is in compliance with the Act and applicable FDA regulations. 
 
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct the violations cited above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction.
 
In addition to the violations cited above, we have the following comments regarding your dietary supplement products:
 
You must collect and hold reserve samples of each lot of your packaged and labeled dietary supplements that you distribute, as required by 21 CFR 111.83(a). However, we note that reserve samples of your Aloe Spring (lots 0214, 0213 and 0713) and Aloe Pearl (lot 4112-EA86) dietary supplement products were not held.
 
We also note that you must establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103.
 
Further, the revised batch production record for your Flora G dietary supplement product (b)(4) that you included with your written response dated April 29, 2014 identifies two dates of cleaning the equipment and processing lines used in producing the batch, as required by 21 CFR 111.260(c). However, there appears to have been production of this lot on (b)(4). To the extent the equipment and processing lines were used to manufacture other products during the timeframe of production indicated on the batch production record, we note that you must maintain, clean, and sanitize, as necessary, all equipment, utensils, and any other contact surfaces used to manufacture, package, label, or hold components or dietary supplement, as required by 21 CFR 111.27(d).
 
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 non-compliance materially related to a food safety requirement of the Act, specifically to determine 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 reinspection 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 non-compliance materially related to a food safety requirement of the Act.  Accordingly, FDA may assess fees to cover any costs related to reinspection.
 
We request that you notify this office in writing within 15 working days from your receipt of this letter of the current status of your corrective actions and the specific steps you have taken to correct the violations cited in this letter and to prevent similar violations in the future. Your response should include any documentation necessary that would assist us in evaluating your corrections. 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.
 
Your written response should be directed to the U.S. Food and Drug Administration, Attention: Nancy G. Schmidt, Compliance Officer, at the above address. If you have questions about this letter, please contact Ms. Schmidt at (303) 236-3046.
 
 
Sincerely,
/S/ 
LaTonya M. Mitchell
Denver District Director

Page Last Updated: 12/30/2014
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