Inspections, Compliance, Enforcement, and Criminal Investigations

Herbal Energetics/In Joy Organics 2/25/16

  

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

Public Health Service
Food and Drug Administration
 
New England District Office
One Montvale Avenue, 4th floor
Stoneham, MA 02180
Phone 781.587.7500
Fax 781.587.7556 

 

WARNING LETTER
CMS # 484202
 
VIA UNITED PARCEL SERVICE
 
February 25, 2016
 
Ms. Carolyn Kelley, Owner
Herbal Energetics/ In Joy Organics
32 Bay Hill Road
Northfield, NH 03276-4617
 
Dear Ms. Kelley:
 
The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 32 Bay Hill Road, Northfield, NH from September 23 through October 16, 2015. We collected product labels during the inspection and reviewed your website for products you manufacture, including “X Out-Rays,” “Stop It Cold,” “SOS Flower Essence,” “Decongest,” “Smoke No More,” “Goodbye Pain,” “Cough Release for Babies and Small Children,” “Cough Release,” “Childrens Stop It…Cold Flu,” “Viral Resolve,” and “Flu the Coop.” Based on the inspection and a review of your product labeling, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act). You may find the Act and its implementing regulations through links on FDA’s home page at www.fda.gov.
 
Unapproved New Drugs
 
The FDA reviewed your website at http://InJoyNow.com in February 2016 and has determined that you take orders there for your products “X Out-Rays,” “Stop It Cold,” “SOS Flower Essence,” “Decongest,” “Smoke No More,” “Goodbye Pain,” “Cough Release for Babies and Small Children,” “Cough Release,” “Childrens Stop It…Cold Flu,” “Viral Resolve,” and “Flu the Coop.” The claims on your website establish that the products are drugs under Section 201(g)(1)(B) of the Act [21 United States Code (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: 
 
X Out-Rays
  • This formula is full of herbs for radio-protection…”
Stop it Cold
  • "Stops cold symptoms in their tracks.”
SOS Flower Essence
  • “Indications: for trauma…”
Decongest (product name is an implied claim)
 
Goodbye Pain
  • “Aids in relieving common every day pain.”
Cough Release for Babies and Small Children (product name is an implied claim)
 
Cough Release (product name is an implied claim)
 
Childrens Stop It…Cold Flu (product name is an implied claim)
 
Viral Resolve (product name is an implied claim)
 
Flu the Coop (product name is an implied claim)
  • “Visualize yourself flying out of the ‘flu trap’ with this perfect formula.”
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, these 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. 
 
Adulterated Dietary Supplements
 
Even if yourX Out–Rays”product did not have therapeutic claims which makes it an unapproved new drug, the product would still be an adulterated dietary supplement within the meaning of Section 402(g)(1) of the Act [21 U.S.C. §342(g)(1)] because the product has been prepared, packed, or held under conditions that do not meet the current Good Manufacturing Practice (CGMP) regulations for dietary supplements in Title 21 of the Code of Federal Regulations, Part 111 (21 CFR Part 111). Further, all other dietary supplement products your firm manufactures are adulterated within the meaning of Section 402(g)(1) of the Act for the same reason.
 
During the September 23 through October 16, 2015 inspection, our FDA investigator observed the following serious violations of the CGMP regulations for dietary supplements: 
 
1.    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). Specifically:
  • For each component that you use in the manufacture of a dietary supplement, you failed to establish component specifications  for limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(b)(3). For example, you do not have contamination limit specifications for heavy metals and filth for Ashwaganda, a dietary ingredient where heavy metals and filth are reasonably likely to be present, which was used in the manufacture of Lot 14113 of your “X Out-Rays” product.
  • For each dietary supplement that you manufacture, you failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contaminations that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement, as required by 21 CFR 111.70(e).
Once you have established the above specifications, you must determine that the specifications have been met as required by 21 CFR 111.73. We also note that you must make and keep records for established specifications, as required by 21 CFR 111.95(b)(1).
 
2.    You failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting material review and making a disposition decision, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103. Specifically, you did not establish written procedures for your firm’s quality control operations for conducting material review.
 
We acknowledge at the close of the inspection, you established some written procedures for the responsibilities of quality control operations. However, you did not have written procedures for conducting material review.
 
3.    Your batch production record (BPR) fails to include complete information relating to the production and control of each batch, as required by 21 CFR 111.255(b). Specifically, your batch record for your Lot 14113 of  “X Out-Rays product fails to include the following required information as required by 21 CFR 111.260:
  • The identity and weight or measure of each component used [21 CFR 111.260(e)];
  • Documentation, at the time of performance, of the manufacture of the batch, including the initials of the persons performing each step, including [21 CFR 111.260(j)(2)]:
o   The initials of the person responsible for weighing or measuring each component used in the batch;
o   The initials of the person responsible for verifying the weight or measure of each component used in the batch;
o   The initials of the person responsible for adding the component to the batch; and
o   The initials of the person responsible for verifying the addition of components to the batch;
  • Documentation at the time of performance that quality control personnel approved and released, or rejected the batch for distribution, including any reprocessed batch [21 CFR 111.260(l)(3)].
Dietary Supplement Labeling Violations
 
Even if your “X Out-Rays” product was not an unapproved new drug, it would still be a misbranded dietary supplement under Section 403 of the Act [21 U.S.C. §343] because the product does not comply with the labeling requirements for dietary supplements. The inspection revealed the following violations of labeling requirements for dietary supplements:
 
1.    Your “X Out-Rays” product is 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 of your product does not comply with 21 CFR 101.36. Specifically, your product label fails to bear nutrition information in the form of a “Supplement Facts” panel.
 
2.    Your “X Out-Rays” product is misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because the label fails to identify the product using the term “dietary supplement” as required by 21 CFR 101.3(g). Dietary supplements shall be identified by the term “dietary supplement” as a part of the statement of identity, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product.
 
3.    Your “X Out-Rays” product is misbranded within the meaning of Section 403(u) of the Act [21 U.S.C. 343(u)] in that it purports to contain ginseng, but the purported ginseng ingredient is not from a plant classified with the genus Panax. Section 403(u) of the Act, added by the Farm Security and Rural Investment Act of 2002 (Pub L. 107-171), provides that the term “ginseng” may only be considered to be a common or usual name (or part thereof) for any herb or herbal ingredient derived from a plant classified within the genus Panax. Specifically, your product contains an ingredient identified as “Eleuthero Rt. (Siberian Ginseng).” This ingredient may not be declared under a name that includes the term “ginseng” because it is not from the genus Panax.
 
4.    Your “X Out-Rays” product is 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).
 
5.    Your “X Out-Rays” product is 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 names of each ingredient, as required by 21 CFR 101.4(h) and 21 CFR 101.36. Specifically, your product contains the Flower Essence ingredients, “Mimulus” and “SOS Rescue,” which are not common or usual names of the ingredients.
 
This letter is not intended to be an all-inclusive list of violations that may exist at your facility or in connection with the products that you manufacture or distribute. It is your responsibility to ensure the products you manufacture and distribute are in compliance with all requirements of the Act and applicable FDA regulations. You should take prompt action to correct the violations described in this letter and establish and implement procedures that will prevent these and other violations in the future. Failure to promptly correct these violations may result in enforcement action, without further notice, including, without limitation, seizure and/or injunction.
 
In addition to the above violations, we further note the following:
 
Your master manufacturing record (MMR) for your “X Out-Rays” product fails to include the following required information, as required by 21 CFR 111.210:
  • Written instructions for manual operations for specific actions including: (A) One person weighing or measuring a component and another person verifying the weight or measure; and (B) One person adding the component and another person verifying the addition [21 CFR 111.210(h)(3)(ii)(A) & (B)].
  • Written instructions for corrective action plans for use when a specification is not met [21 CFR 111.210(h)(5)]. 
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 in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct the violations noted above and prevent their future recurrence. You should include in your response documentation and any other useful information that would assist us in evaluating your corrections. If you cannot complete the corrective actions within fifteen working days, state the reason for the delay and the date by which you will have completed the correction. 
 
Please send your written reply to the Food and Drug Administration, Attention: CAPT Diane M. Prince, Compliance Officer, One Montvale Ave, Stoneham, MA 02180. If you have questions regarding any issues in this letter, please contact CAPT Prince at 781-587-7442.
 
Sincerely,
/S/
Lori A. Holmquist
Acting District Director
New England District Office
 
 
cc: Colleen Smith, Administrator
Food Protection Section
Bureau of Public Health Protection
New Hampshire Division of Public Health Services,
Department of Health and Human Services
29 Hazen Drive
Concord, NH  03301-6504

 

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