From August 30, 2016 through December 19, 2016, the U.S. Food and Drug Administration (FDA) inspected your facility located at 7884 S. Quincy St. Willowbrook, Illinois. During the inspection, our investigator found a number of violations of the current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulation, Title 21, Code of Federal Regulations, Part 111 (21 CFR 111). These violations cause your dietary supplements 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 they have been prepared, packed, or held under insanitary conditions that do not meet cGMP regulations for dietary supplements.
In addition, we have reviewed your product labeling collected during the inspection and your websites at http://www.liferising.com/index.html and http://www.liferising.com/know/guide/guide.html. Based on our review, we have concluded that your products are in violation of sections 403, 505(a), and 502(f)(1) of the Act [21 U.S.C. §§ 343, 355(a), and 352(f)(1)] and regulations implementing the food labeling requirements of the Act, which are found in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You can find the Act and FDA regulations through links on FDA's website at
www.fda.gov.
Unapproved New Drugs and Misbranded Drugs
FDA reviewed your websites at the Internet addresses http://www.liferising.com/index.html and http://www.liferising.com/know/guide/guide.html in April 2017 and has determined that you take orders there for the products "Stomach Regulator," Fang Feng Formula," Skin Regulator," Regulate Liver," Circulation Regulator, " Pancreas Support," "Lung Regulator," "Pure Tea," "
Liver Regulator-2," "Licorice, Wheat & Date," "Spleen Support-GPT," "Spleen Regulator," "Circulation Maintenance," "Lung Support-Y," "Liver Regulator-2," and Lung Support." We have also reviewed the product labeling for "Stomach Regulator," Fang Feng Formula," and "Licorice, Wheat & Date" collected during the inspection referred to above. The claims on your website and product labeling establish that the products are drugs under section 201(g)(1)(B) of 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. You can find the Act and FDA regulations through links on FDA's home page at www.fda.gov.
Examples of some of the website and labeling claims that provide evidence that your products are intended for use as drugs include:
Stomach Regulator
"[S]tomach acid or pain..."
Fang Feng Formula...
"[D]ark and burning urine, skin rashes or infections, boils, carbuncles, hemorrhoids, intestinal bleeding..."
Skin Regulator-A
"[R]ashes, hives, abscesses..."
Regulate Liver
"[H]ypertension..."
Circulation Regulator
"[S]kin rashes...Mouth sores"
Pancreas Support
"Diabetes, high blood sugar..."
Lung Regulator
"[R]osacea..."
Pure Tea
"[M]outh sores..."
Liver Regulator-2
"
Depression...insomnia..."
Licorice, Wheat & Date
"
Depression...insomnia..."
Spleen Support-GPT
"
Depression...Insomnia...palpitation..."
Spleen Regulator
"
Insomnia..."
Circulation Maintenance
"
Hypertension...high cholesterol..."
Lung Support-Y
"[B]
ronchitis, or pneumonia..."
Liver Regulator-2
"
Depression...insomnia..."
Lung Support
"
Asthma, bronchitis..."
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 new drugs 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 "
Liver Regulator-2," "Licorice, Wheat & Date," "Spleen Support-GPT," "Spleen Regulator," "Circulation Maintenance," "Lung Support-Y," "Liver Regulator-2," and Lung Support," 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, "
Liver Regulator-2," "Licorice, Wheat & Date," "Spleen Support-GPT," "Spleen Regulator," "Circulation Maintenance," "Lung Support-Y," "Liver Regulator-2," and Lung Support" 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)].
Adulterated Dietary Supplements
Dietary Supplement CGMP Violations
Even if the products listed above did not have disease claims which make them drugs, the dietary supplement products are adulterated. The August 30, 2016 through December 19, 2016 inspection of your facility revealed the following 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 in that they have been prepared, packed, or held under conditions which do not meet the cGMP regulations for dietary supplements.
The following cGMP violations were observed during the inspection:
1. You failed to establish specifications for each dietary supplement that you manufacture 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, as required by 21 CFR 111.70(e). Specifically, during the inspection you stated to our investigators that you do not have established finished product specifications for any of your dietary supplement products.
Once you have established product specifications, you must determine whether the specifications have been met as required by 21 CFR 111.75(c).
We have reviewed your response letters, dated December 30, 2016 and April 17, 2017. You state that you have created records of established specifications for the finished dietary supplement products; however, you did not provide documentation regarding the established finished product specifications for your firm's finished dietary supplement products. We intend to verify the adequacy of your corrective action at a future inspection.
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 and for approving or rejecting any reprocessing, as required by 21 CFR 111.103.Specifically, during our inspection, it was observed that you do not have any written quality control operation procedures, including procedures that describe how you conduct a material review and make a disposition decision for components or finished dietary supplements that failed to meet specifications, a deviation or unanticipated occurrence during the manufacturing, packaging, labeling or holding operations. Further, you do not have any documentation to support the review and disposition of components used to manufacture your dietary supplements at the Willowbrook, IL facility, nor do you have any documentation to support the review and disposition of any of your finished dietary supplements into commerce.
Aside from the finished dietary supplement products you manufacture, your firm also holds and distributes dietary supplement products under your firm's name that are manufactured by
(b)(4). located in
(b)(4); therefore, your firm has 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 [See 72 Fed. Reg. 34752, 34790 (June 25, 2007)].
Although a firm may contract out certain dietary supplement manufacturing operations, it cannot contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is 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 wrong doing, 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 or delivering for introduction, or causing the delivery or introduction, into interstate commerce 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 331(a)). Thus, a firm that contracts out some or all of its operations must establish a system of production and process controls 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 111.55). The quality control personnel must ensure that the 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 (21 CFR 111.105).
We have reviewed your response letters, dated December 30, 2016 and April 17, 2017.
You state that you have created procedures for the responsibilities of the quality control operations for conducting a material review and making a disposition decision of the raw materials, components or finished dietary supplements received; however, you did not provide any documentation that you have established these procedures or that they are implemented into your operations. We intend to verify the adequacy of your corrective action at a future inspection.
3. You failed to prepare and follow a written master manufacturing record for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure the uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205(a). Specifically, during the inspection you stated to our investigators that no manufacturing records are prepared when manufacturing dietary supplement capsule product at the Life Rising Corporation Willowbrook, IL facility.
We have reviewed your response letter, dated December 30, 2016. You state that you will implement a system of production and process controls that covers all stages of manufacturing, packaging, labeling and holding of dietary supplements to ensure the quality of the dietary supplement. You state in the signed affidavit that all production of teas and capsules at Life Rising Corporation has been discontinued as of 08/01/2016 and you plan to resume production of your dietary supplements at a future date. You must have a written master manufacturing record for each unique formulation of dietary supplement that you manufacture and follow it for each batch size to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205(a). The master manufacturing record for a particular formulation and batch size would be completed prior to resuming manufacturing operations for the dietary supplement product at the Life Rising Corporation Willowbrook, IL facility.
4. You failed to prepare a batch production record every time you manufacture a batch of a dietary supplement, as required by 21 CFR 111.255(a). Specifically, during the inspection you stated to our investigators that no manufacturing records are prepared when manufacturing dietary supplement capsule product at the Life Rising Corporation Willowbrook, IL facility.
We have reviewed your response letter, dated December 30, 2016. You state that you will implement a system of production and process controls that covers all stages of manufacturing, packaging, labeling and holding of dietary supplements to ensure the quality of the dietary supplement. You state in the signed affidavit that all production of teas and capsules at Life Rising Corporation has been discontinued as of 08/01/2016 and you plan to resume production of your dietary supplements at a future date. When you resume production of a unique formulation and batch size of a dietary supplement, you must make and keep batch production records for every such batch of a dietary supplement that you manufacture at the Life Rising Corporation Willowbrook, IL facility, as required by 21 CFR 111.255.
5. You failed to establish written procedures for holding and distributing operations, as required by 21 CFR 111.453. Specifically, you have not established written procedures for holding and distributing operations.
We have reviewed your response letters, dated December 30, 2016 and April 17, 2017. You state that you have created written procedures for holding and distributing operations; however, you did not provide any documentation of these written procedures. We intend to verify the adequacy of your corrective action at a future inspection.
6. You failed to establish and follow written procedures to fulfill the requirements related to product complaints, as required by 21 CFR 111.553. Specifically, you have no written procedures for the review and investigation of product complaints, nor do you have records documenting the complaints you have received, your response, or any investigation which may have been performed. Once you establish the necessary written procedures, you must make and keep records for the review and investigation of product complaints, in accordance with 21 CFR 111.570.
We have reviewed your response letters, dated December 30, 2016 and April 17, 2017. Your response did not provide evidence product complaint procedures have been established, as required by 21 CFR 553. We intend to verify the adequacy of your corrective action at a future inspection.
7. You failed to calibrate instruments and controls used in the manufacturing of your dietary supplements, as required by 21 CFR 111.27(b). Specifically, blenders, scales, and balances were used in the manufacturing of your dietary supplement products without any calibration being performed.
We have reviewed your response letters, dated December 30, 2016 and April 17, 2017. You state that you have created written procedures to address the requirements for the manufacturing and packaging of dietary supplements; however, you did not provide any documentation of these written procedures. We intend to verify the adequacy of your corrective action at a future inspection.
Misbranded Dietary Supplements
During our inspection, we reviewed the labeling of your dietary supplement products, including DHZC-2 Blood Circulation Regulator (Lower Abdomen) tablet, Brain-ECM capsule, TT Side Regulator tablet, and SHT Chest Relief capsule products and determined that these products are misbranded foods under section 403 of the Act [21 U.S.C. § 343] in that the labels for these products do not comply with the labeling requirements in 21 CFR 101 for the reasons described below:
1. Your DHZC-2 Blood Circulation Regulator (Lower Abdomen) tablet, Brain-ECM capsule, TT Side Regulator tablet, and SHT Chest Relief capsule products 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 full 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.
2. Your
DHZC-2 Blood Circulation Regulator (Lower Abdomen) 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).
3. Your
Brain-ECM capsules product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343 (i)(2)] because the product is contained in capsules, but the capsule ingredients are not listed on the label, as required by 21 CFR 101.4(g).
The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that all of your products and labeling are in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct the violations. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
We offer the following comments:
1. You failed to identify each unique lot within each unique shipment of packaging in a manner that allows you to trace the lot to the supplier, the date received, the name of the packaging, the status of the packaging, and to the dietary supplement that you distributed, as required by 21CFR 111.160(d)(1). Specifically, during the inspection it was observed each unique shipment of packaging was not identified in a manner that allows for traceability to the dietary supplement that was ultimately packaged and distributed.
2. Although your SHT Chest Relief capsule product declares the ingredient "Red rooted sage" and your TT Side Head Regulator tablet product declares the ingredient
"Chinese thoroughwax" and these names are consistent with names noted in Herbs of Commerce, 1st edition, 1992, we note that there is a more up-to-date edition, Herbs of Commerce, 2nd edition, 2000. We also note that 21 CFR 101.4(h) has not been updated with respect to the later edition of Herbs of Commerce.
3. FDA analysis of finished product samples of your
DHZC-2 Blood Circulation Regulator (Lower Abdomen) tablet product collected on June 28, 2016, Brain-ECM capsule product collected on September 14, 2016, SHT Chest Relief capsule product collected on October 13, 2016, and TT Side Regulator tablet product collected on October 20, 2016 confirmed the presence of high levels of lead in all of the products. We acknowledge that you have voluntarily recalled your DHZC-2 Blood Circulation Regulator (Lower Abdomen) tablet, Brain-ECM capsules, TT Side Regulator tablet, and SHT Chest Relief capsule products related to these analytical findings. Please continue provide this office with the status of your activities of this on-going recall and any action plan you have to prevent this from reoccurring.
Please notify this office in writing within fifteen (15) working days from your receipt of this letter as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur. Your response should i
nclude any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, please explain the reason for the delay and state the date by which the corrections will be completed.
As the importer of record, it is your responsibility to ensure that imported products meet all requirements of the Act and the regulations, which include holding the product intact until it is released by FDA. Your firm also has an ongoing responsibility to ensure that all import brokers, consignees and others working with you hold the imported product intact until such time as FDA releases it or authorizes it to be exported or destroyed. Introduction into or receipt in interstate commerce of any article that is adulterated or misbranded is a violation of the Act. This violation may result in regulatory action without further notice such as seizure, detention without physical examination of shipments, debarment, injunction and prosecution. In addition, failure to promptly correct this situation and prevent future premature distribution of imported products may result in requiring that future shipments be held in secured storage. Secured storage will be under the supervision and direction of the U.S. Customs Border Protection, such as in a bonded warehouse. You will be responsible for all costs incurred in secured storage.
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 from the responsible party of the domestic facility. 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 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 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.
