Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm502275.htm
Timestamp: 2019-04-23 22:15:19+00:00

Document:
Beauty & Health International, Inc.
The United States Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility, Beauty & Health International Inc., located at 7541 Anthony Avenue, Garden Grove, California on August 25, 2015 to August 28, 2015. The inspection revealed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under 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 they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. The investigator’s observations were noted on form FDA-483, Inspectional Observations, which was issued to you on August 28, 2015.
Additionally, our investigator collected and reviewed labeling of your dietary supplements. Further, your products bear your internet website address “www.nutriwell.net” and we reviewed the labeling on your website at www.nutriwell.net in October of 2015. Based on our review, we have concluded that your products identified below are in violation of sections 403, 505(a), and/or 502(f)(1) of the Act [21 U.S.C. §§ 343, 355(a), and/or 352(f)(1)]. You may find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
We received a written response from you dated September 23, 2015, concerning our investigator’s observations noted on the FDA 483 issued to you. We address each relevant response, in relation to each of the noted violations.
The FDA reviewed your products labels and your website at www.nutriwell.net in October of 2015, and has determined that you take orders there for your “Dr. Immune H-100,” “Nopal with Garlic,” “Tea Tree Oil,” “Shea Butter Oil,” “Ginseng Gro Oil,” “Eye Wrinkle Cream,” and “Quinol” products. The claims on your product labels and your website establish that the products are drugs under section 201(g)(1) of the Act [21 U.S.C. 321(g)(1)] because they are intended for use in the cure, mitigation, treatment or prevention of disease and/or articles intended to affect the structure or any function of the human body, rendering them drugs under the Act. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
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.
Your “Dr. Immune H-100” and “Nopal with garlic” products 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, your “Dr. Immune H-100” and “Nopal with garlic” products 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 of or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)].
Specifically, during our inspection, our investigators observed the following violations, which were noted on form FDA 483, Inspectional Observations, issued to you on August 28, 2015. As of September 23, 2015 you failed to provide a response to address the serious observations, which were presented to you during the inspection of your facility and you failed to provide any documentation that indicates you have begun an effective corrective action plan to bring your firm into compliance with 21 CFR Part 111.
You failed to establish in-process specifications for any point, step, or stage in the master manufacturing record where control is necessary to help ensure that specifications are met for the identity, purity, strength, and composition of the dietary supplements and, as necessary, for limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement, as required by 21 CFR 111.70(c)(1).
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 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).
Once you have established component and product specifications, you must verify that the specifications are met in accordance with 21 CFR 111.75.
We have reviewed your response dated September 23, 2015, and we are unable to evaluate the adequacy of your response because you failed to provide evidence of having established component, in-process, or finished 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.
Specifically, you have not established written procedures for quality control operations for component receiving operations, packaging and labeling operations, laboratory operations, and holding and distributing operations.
Once you have established your written quality control procedures you must implement quality control operations in your manufacturing, 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 have reviewed your response dated September 23, 2015, and we are unable to evaluate the adequacy of your response because you failed to provide evidence of having established written procedures for quality control and operations.
We acknowledge your response, dated September 23, 2015, to the Form FDA 483, Inspectional Observations issued at the close of the inspection. We find your response to be inadequate in that you failed to address the above mentioned requirements under 21 CFR 111.210.
The directions of use on the “Gar-lite” product label suggest the consumer take one or two capsules with meals, but the serving size lists 1 capsule. The serving size listed should be two capsules.
The directions of use on the “Nopal with garlic” product label suggest the consumer take two capsules with a meal, but the serving size lists 1 capsule. The serving size listed should be two capsules.
Your “Gar-lite” and “Nopal with garlic” product labels fail to include the part of the plant from which garlic is derived.
Your “Colonite” product label fails to include the part of the plant from which senna is derived.
3. Your “Nopal with Garlic” product is misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f) because the product label contains information in two languages, but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.
4. Your “Colonite” product is misbranded within the meaning of section 403(q)(5)(f) of the Act [21 U.S.C. §343(q)(5)(f)] because the product label appears to include a proprietary blend, Fiber Blend Concentrate; however, the label does not list the individual ingredients of the blend as required by 21 CFR 101.36(c) and “senna” is not declared within the “Supplement Facts” panel as required by 21 CFR 101.36(b)(3).
This letter is not an intended to be an all-inclusive list of violations 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 establishment and your products comply with the Act and its implementing regulations. You should take prompt action to correct all violations noted in this letter.
Failure to promptly correct these violations may result in enforcement action without further notice, such as seizure and/or injunction.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and to prevent similar violations from occurring in the future. You should include in your response documentation and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
If you have any questions about the content of this letter, please contact Jessica Mu, Compliance Officer, at 949-608-4477. Include Special Identifier FEI #3004377822 on all correspondence.

References: § 342
 § 321
 § 355
 § 331
 § 352
 § 331
 §343
 §343