Inspections, Compliance, Enforcement, and Criminal Investigations

Nature's Mojo Inc 11/12/15

  

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

Public Health Service
Food and Drug Administration
 New Jersey District
10 Waterview Blvd., 3rd Floor
Parsippany, NJ 07054
Phone: 973-331-4917
Fax: 973-331-4969 

 

November 12, 2015
 
WARNING LETTER
 
VIA UNITED PARCEL SERVICE, OVERNIGHT DELIVERY
RETURN RECEIPT REQUESTED
Ms. Beatriz Chavez, Owner
Nature's Mojo, Inc.
112-114 Hillcrest A venue
Ledgewood, New Jersey 07852
16-NWJ-02
Dear Ms. Chavez:
 
The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility, located at 112 Hillcrest Avenue, Ledgewood, New Jersey, from June 17, 2015, through June 22, 2015. Based on our inspection and subsequent review of your firm's website, we identified serious violations of the Federal Food, Drug and Cosmetic Act (the Act) and its implementing regulations. You can find the Act and FDA's regulations through links on FDA's home page at http://www.fda.gov.
 
Unapproved New Drugs and Misbranded Drugs
 
The FDA reviewed your website at the Internet address www.naturesmojostore.com in August 2015 and has determined that you take orders there for your "Alfalfa Leaf Liquid Extract," "Ginkgo Biloba Leaf Liquid Extract," "Echinacea Purpurea Herb Liquid Extract," "Ashwagandha Root Liquid Extract," "Dandelion Leaf Liquid Extract," "Ginger Root Liquid Extract," "Hawthorn Berry Fruit Liquid Extract," "Juniper Berry Liquid Extract," "Milk Thistle Seed Liquid Extract," and "Wheat Grass Liquid Extract" products, which are intended for use for conditions that cause the products to be drugs under section 201(g)(l)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your website establish that the products 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:
 
Alfalfa Leaf Liquid Extract
• "May be very beneficial in easing pain from both osteo and rheumatoid arthritis, helpful for those who suffer kidney or bladder conditions ... aid in blocking the absorption of cholesterol."
 
Ginkgo Biloba Leaf Liquid Extract
• "It can also be beneficial for conditions due to reduced blood flow to the brain ... headache ... hearing disorders.
 
Echinacea Purpurea Herb Liquid Extract
• "Often Referred to as Nature's BEST Immune System Enhancer, it is useful in Diminishing the length and Severity of the Common Cold, Viruses, Fever, Earache, and Respiratory Infections."
 
Ashwagandha Root Liquid Extract
• "Often used to EASE Arthritis, Rheumatism, Sciatica and other Chronic inflammatory diseases."
 
Dandelion Leaf Liquid Extract
• "It has been used for thousands of years and used to treat anemia, scurvy, skin problems, blood disorders and depression ... and inhibits microbial growth in the urinary system."
 
Ginger Root Liquid Extract
• "[G]inger has also been Used to HELP Reduce Fevers, RELIEVE Headache ... HELP REMOVE Toxins from the body. Preliminary studies Suggest that Ginger Root Extracts may Lower Cholesterol. Ginger Contains Very Potent Anti-Inflammatory compounds called Gingerols, Believed to REDUCE Pain and Inflammation Associated with osteoarthritis or rheumatoid arthritis, and IMPROVE Joint Mobility."
 
Hawthorn Berry Fruit Liquid Extract
• "Believed to be Beneficial for arteriosclerosis, allergies, sinusitis, and May have Cholesterol Lowering Effects."
 
Juniper Berry Liquid Extract
• "The extract is commonly used to alleviate ... GI infections, heartburn ... It may also be useful for those who suffer from kidney or bladder stones."
 
Milk Thistle Seed Liquid Extract
• "Properties in this herb are believed to PROMOTE Normal Cholesterol ... Those who have used this extract for Skin Improvement of Psoriasis, Rosacea or Eczema ... "
 
Wheat Grass Liquid Extract
• "Uses for wheat grass are varied, including improving blood sugar disorders, removing toxins from the blood and liver, reducing cholesterol, accelerating wound healing ... "
 
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 marketed in the U.S. without prior approval from 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 "Echinacea Purpurea Herb Liquid Extract," "Ashwagandha Root Liquid Extract," "Dandelion Leaf Liquid Extract," "Hawthorn Berry Fruit Liquid Extract," "Juniper Berry Liquid Extract," "Milk Thistle Seed Liquid Extract," and "Wheat Grass Liquid Extract" 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 [21 U.S.C. § 352(f)(1)], in that their labeling fails to bear adequate directions for uses. The introduction of or delivery for introduction into interstate commerce of these products is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
 
Adulterated Dietary Supplements
 
Even if your "Ginkgo Biloba Leaf Liquid Extract," "Echinacea Purpurea Herb Liquid Extract," "Dandelion Leaf Liquid Extract," "Ginger Root Liquid Extract," and "Hawthorn Berry Fruit Liquid Extract" products did not have therapeutic claims which make them unapproved drugs, these products would be adulterated dietary supplements under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(l)] in that they have been prepared, packed, or held under conditions that do not meet the Current Good Manufacturing Practice (CGMP) requirements for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).
 
During the inspection, our investigators were informed that your firm has entered into agreements with manufacturers who manufacture dietary supplement products that your firm packages, labels, holds, and distributes. Further, our investigators were informed that your firm is ultimately responsible for marketing and distributing your finished dietary supplement products. As a distributor that contracts with other manufacturers to manufacture dietary supplements that your firm releases for distribution under your firm's name, your firm has an obligation to know what and how these activities are performed so that you can make decisions related to whether your dietary supplement products conform to established specifications and whether to approve and release the products for distribution [72 Fed. Reg. 34752, 34790 (Jun. 25, 2007)]. Your firm introduces or delivers, or causes the introduction or delivery of, dietary supplements into interstate commerce in their final form for distribution to consumers. As such, your firm has an overarching and ultimate responsibility to ensure that all phases of the production of those products are in compliance with dietary supplement CGMP requirements found under 21 CFR Part 111.
 
Although your firm may contract out certain dietary supplement manufacturing operations, it cannot, by the same token, contract out its ultimate responsibility to ensure that the dietary supplements it places into commerce (or causes to be placed into commerce) are not adulterated for failure to comply with dietary supplement CGMP requirements (see United States v. Dotterweich, 320 U.S. 277,284 (1943) (explaining that an offense can be committed under the Act by anyone who has "a responsible share in the furtherance of the transaction which the statute outlaws"); United States v. Park, 421 U.S. 658, 672 (1975) (holding that criminal liability under the Act does not turn on awareness of wrongdoing, and that "agents vested with the responsibility, and power commensurate with that responsibility, to devise whatever measures are necessary to ensure compliance with the Act" can be held accountable for violations of the Act)). In particular, the Act prohibits a person from introducing, delivering for introduction, or causing the delivery or introduction into interstate commerce of a dietary supplement that is adulterated under section 402(g) for failure to comply with dietary supplement CGMP requirements (see 21 U.S.C. 342(g) and 33l(a)). Thus, a firm that contracts with other firms to conduct certain dietary supplement manufacturing operations for it is responsible for ensuring that the product is not adulterated for failure to comply with dietary supplement CGMP requirements, regardless of who actually performs the dietary supplement CGMP operations.
 
As a distributor, you have an obligation to know what and how manufacturing activities are performed so that your firm can make decisions related to whether your packaged and labeled dietary supplement products conform to established specifications and whether to approve and release the products for distribution. Your quality control personnel must approve for release, or reject, any packaged and labeled dietary supplement (including a repackaged or relabeled dietary supplement) for distribution. See 21 CFR 111.127.
 
During our inspection, our investigators observed the following significant violations, which were noted on Form FDA 483, Inspectional Observations, issued to you on June 22, 2015. We received your written response, dated July 13, 2015, to the Form FDA 483. Your response is discussed in more detail below.
 
1.     You failed to establish product specifications to provide sufficient assurance that the product you receive from a supplier for packaging and labeling as a dietary supplement (and for distribution rather than for return to the supplier) is adequately identified and consistent with your purchase order, as required by 21 CFR 111.70(f). Specifically, you have not established any product specifications.
 
We acknowledge your response, dated July 13, 2015, to the Form FDA 483, Inspectional Observations issued at the close of the inspection. However, we are unable to determine the adequacy of your response. While you stated that policies and procedures will be written to establish product specifications for each product distributed, you did not include any supporting documentation regarding the product specifications.
 
2.    You failed to 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, as required by 21 CFR 111.103 and 21 CFR 111.140(b). Specifically, you do not have standard operating procedures or other written procedures for quality control which define the responsibilities of your quality control operations. Additionally, you failed to have quality control incorporated in your release processes of your packaged and labeled dietary supplements.
 
Once you have established quality control procedures for the responsibilities of your quality control operations, you must implement quality control operations in your packaging, labeling, and holding operations for producing the 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 111.65.
 
We acknowledge your response, dated July 13, 2015, to the Form FDA 483, Inspectional Observations issued at the close of the inspection. However, we are unable to determine the adequacy of your response.  While you stated that policies and procedures will be written to detail the quality control operations and responsibilities, you did not include any supporting documentation regarding your proposed new process.
 
3.    You failed to make and keep records of product distribution, as required by 21 CFR 111.475(b)(2). You distribute packaged and labeled liquid dietary supplements from your contract manufacturers through online sales or directly to consumers who occasionally pick up their order at your facility; however, you do not have any customer lists or records of product distribution.
 
Misbranded Dietary Supplements
 
Further, even if your "Echinacea Purpurea Herb Liquid Extract" and "Ginkgo Biloba Liquid Extract products were not an unapproved new drugs, they would still be misbranded dietary supplements within the meaning of section 403 of the Act [21 U.S.C. § 343]. The inspection revealed the following violations of labeling requirements for dietary supplements:
 
1.  Your "Echinacea Purpurea Herb Liquid Extract" and "Ginkgo Biloba Liquid Extract products are misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because the labels fail to identify the products using the term "dietary supplement" as required by 21 CFR 101.3(g).
 
2. Your "Echinacea Purpurea Herb Liquid Extract," and "Ginkgo Biloba Liquid Extract" products are misbranded within the meaning of 403{q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that the labels fail to bear nutrition information ("Supplements Facts" panel) as required by 21 CFR 101.36.
 
3. Your "Echinacea Purpurea Herb Liquid Extract" and "Ginkgo Biloba Liquid Extract" products are misbranded within the meaning of section 403(q)(1)(A) because the serving size is not present on the labels.
 
4. Your "Echinacea Purpurea Herb Liquid Extract" and "Ginkgo Biloba Liquid Extract" products are misbranded within the meaning of Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the labels fail to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.
 
5. Your "Echinacea Purpurea Herb Liquid Extract" and "Ginkgo Biloba Liquid Extract" products are misbranded within the meaning of section 403(i)(2) of the Act in that the product labels fail to declare each ingredient used as required by 21 CFR 101.4.
 
6. Your "Echinacea Purpurea Herb Liquid Extract" and "Ginkgo Biloba Liquid Extract" products are misbranded within the meaning of Section 403(q)(1)(B) because the labels fail 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).
 
7. Your "Echinacea Purpurea Herb Liquid Extract" and "Ginkgo Biloba Liquid Extract" product labels are misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to bear 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 supplement.
 
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. 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 complies with all requirements of federal law and FDA regulations.
 
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
 
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
 
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 noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
 
Your response should be sent to the following address: U.S. Food and Drug Administration, 10 Waterview Blvd., Parsippany, 3rd Floor, New Jersey 07054.  If you should have any questions regarding any issue in this letter, please contact Andrew Ciaccia, Compliance Officer.
 
Sincerely,
/S/
Craig W. Swanson
Acting District Director
New Jersey District

Page Last Updated: 11/20/2015
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