Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lifehealth-science-599467-05152020
Timestamp: 2020-08-10 19:02:33
Document Index: 539813947

Matched Legal Cases: ['§ 321', '§ 321', '§ 331', '§ 352', '§ 353', '§ 352', '§ 331', 'art 111', '§ 342', '§ 343', '§ 343']

LifeHealth Science - 599467 - 05/15/2020 | FDA
LifeHealth Science MARCS-CMS 599467 — May 15, 2020
Bert Moyar
1632 Enterprise Parkway, Suite F
Twinsburg, OH 44087-2281
sophia@lifehealthscience.net
May 15, 202
WARNING LETTER 599467
Dear Mr. Moyar:
The United States Food and Drug Administration (FDA) conducted an inspection of your facility, located at 1632 Enterprise Parkway, Suite F, Twinsburg, Ohio on November 25 through December 11, 2019. During the inspection, we collected labeling for your ORËÁ product and reviewed your website at Internet address www.lhscience.com, where you take orders for your ORËÁ product. Based on inspectional findings and a review of your website, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You can find the Act and FDA regulations through links on the FDA’s Internet home page at http://www.fda.gov
FDA has subsequently reviewed your website at the Internet address www.lhscience.com in March 2020 and has determined you take orders there for your ORËÁ product. The claims on your website establish the product is a drug under section 201(g)(1)(B) of the Act [21 United States Code (USC) § 321(g)(1)(B)] because it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act.
Examples of some of the website claims that provide evidence that your product, ORËÁ, is intended for use as a drug include:
“ORËÁ was developed to create a safe and effective way to support the body's natural ability to remove toxins . . . .If you’re experiencing problems sleeping . . .headaches . . . toxic build-up could be the culprit."
“ORËÁ helps remove heavy metals, biotoxins, solvents, pesticides, and chemicals that can contribute to body aches and pains."
“ORËÁ works at the cellular level to help remove harmful toxins from the body . . .”
“ORËÁ is an all-natural detoxification system designed to restore your health and vitality like no other cleanse can . . . . Symptoms of Toxin Accumulation . . . include: . . . Forgetfulness/Mental Confusion, Mood Changes/Mild Depression, Anxiety . . . Insomnia, Body Aches and Pains . . . Nausea, Vision Problems”
Your ORËÁ product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” under Section 201(p) of the Act [21 USC § 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 USC §§ 331(d) and 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating the drug is safe and effective.
A drug is misbranded under section 502(f)(1) of the Act [21 USC § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” mean 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 USC § 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
Your ORËÁ product is intended for prevention or 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 product safely for its intended purpose. Accordingly, ORËÁ fails to bear adequate directions for its intended use and, therefore, is misbranded under section 502(f)(1) of the Act [21 USC § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of this misbranded drug violates section 301(a) of the Act [21 USC § 331(a)].
Dietary Supplement CGMP Violations/Adulterated Dietary Supplements
Even if your ORËÁ product did not have therapeutic claims that make it an unapproved new drug and misbranded drug, our investigator observed the following violation(s) of the FDA’s Current Good Manufacturing Practice (CGMP) requirements for dietary supplements, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR 111), which render your products adulterated dietary supplements within the meaning of section 402(g)(1) of the Act [21 USC § 342(g)(1)] for the reasons described below.
We received your response dated January 6, 2020, addressing the FDA 483, Inspectional Observations, issued to your firm. Inadequacies in your response are addressed below.
1. You did not establish product specifications for each dietary supplement that you manufacture for the identity, purity, strength, and composition of the finished batch of the dietary supplement, as required by 21 CFR 111.70(e). Specifically, you did not have finished product specifications for identity, purity, strength, and composition of your ORËÁ dietary supplement product.
We have reviewed your January 6, 2020, response. Your response stated you received information on the element composition of your finished product from a third-party analysis and determined finished product strength via (b)(4). You provided the analysis from the third-party laboratory for the raw material and for the finished product. You claim that the company “utilizes the same manufacturing process to make the product today.” However, you still have not provided any documentation that establishes in-progress specifications for each step of the manufacturing process, nor have you explained why the values for the raw material analysis are different from the values for the finished product or how you ensure that the same values are achieved each time a batch is produced. Your response also does not provide documentation stating product specifications with a target yield of the finished product and the allowable variance from the target yield. You have not provided documentation with actual specifications against which you could compare a final certificate of analysis. We are unable to evaluate the adequacy of your response because you have not provided supporting documentation that you have taken corrective action by establishing finished product specifications.
2. You failed to establish component specifications, as required by 21 CFR 111.70(b), for each component that you use in the manufacture of a dietary supplement. For example:
You did not establish component identity specifications; you did not establish component specifications that are necessary to ensure that specifications for the purity, strength, and composition of dietary supplements manufactured using the component are met; for your component (b)(4), you did not establish 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(b)(1), 21 CFR 111.70(b)(2), and 21 CFR 111.70(b)(3). Specifically, you failed to establish component specifications to qualify the Certificate of Analysis (COA) received from your supplier of (b)(4), lot number (b)(4), you currently use to manufacture your ORËÁ dietary supplement product.
You did not establish component specifications for the limits of contamination regarding the (b)(4) your firm uses to manufacture dietary supplements, as required by 21 CFR 111.70(b)(3). Specifically, you test the (b)(4) used as a component in your ORËÁ dietary supplement product for total dissolved solids (TDS); however, you have not established specifications to determine the satisfactory range for TDS present in the (b)(4) nor have you established specifications for other limits on contamination which may be associated with this component.
We have reviewed your January 6, 2020 response. Your response stated you had a third-party laboratory analyze the referenced (b)(4) on (b)(4). This analysis provided the values of “(b)(4)” Element “(b)(4)” that were present in this material which were provided. We are unable to evaluate the adequacy of your response because these values do not represent component product specifications in accordance with 21 CFR 111.70.
3. Your firm’s batch production records (BPRs) did not include all information required in a BPR, as required by 21 CFR 111.255(b) and 21 CFR 111.260. Your batch production record must include complete information relating to the production and control of each batch, as required by 21 CFR 111.255(b). For example, your batch production records for your ORËÁ dietary supplement product, lot numbers Lot # (b)(4), and Lot # (b)(4), did not include the following:
Regarding Lot # (b)(4):
The actual results obtained during any monitoring operation, including the actual temperatures during the “(b)(4)” steps during Production 1 [21 CFR 111.260(g)];
An actual or representative label, or a cross-reference to the physical location of the actual or representative label specified in the master manufacturing record [21 CFR 111.260(k)(2)]
We have reviewed your January 6, 2020 response. You stated original raw data was recorded on (b)(4) and (b)(4) will be performed to ensure this information will be included on (b)(4) in the future. However, we are unable to evaluate the adequacy of your corrective actions because you did not provide documentation of revised batch records.
Misbranded Dietary Supplements:
In addition, your ORËÁ product is a misbranded dietary supplement under Section 403 of the Act [21 USC § 343] because it does not comply with the labeling requirements for dietary supplements as required by 21 CFR 101 as follows:
1. Your ORËÁ product in 30 milliliter (ml) and 60 ml units is misbranded within the meaning of section 403(y) of the Act [21 USC § 343(y)] in that the product label fails 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.
2. Your ORËÁ product in 30 milliliter (ml) and 60 ml units 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 the products does not comply with 21 CFR 101.36.
Your product label fails to include the “Servings Per Container” per 21 CFR 101.36(b)(1)(ii).
Your product label bears the statement “Percent Daily Values are based on a 2,000 calorie diet.” This statement is only permitted when the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein, as required by 21 CFR 101.9(c) and 21 CFR 101.36(b)(2)(iii)(D). None of these dietary ingredients is present on the label, so the statement is not permitted.
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 your firm complies with all requirements of the Act and implementing regulations.
In addition, we also offer the following comments:
1. Your ORËÁ product in 30 milliliter (ml) and 60 ml units’ labels contains the FDA disclaimer statement. However, this disclaimer is not linked to any specific structure function claim on the product label. The FDA disclaimer statement as noted on your product label must be bolded and set off in a box, and the symbol preceding the disclaimer statement must be linked to the same symbol placed at the end of each structure function statement on the label in accordance with 21 CFR 101.93(d) and (e).
2. Your ORËÁ product in 30 milliliter (ml) and 60 ml units’ labels fails to include the correct unit fluid ounce "fl oz" in according 21 CFR 101.07(j)(3).
3. For your ORËÁ product in 30 milliliter (ml) and 60 ml units’ labels, the “other ingredients list” must be placed below the Supplement Facts label, as required by 21 CFR 101.4(g).
4. Your ORËÁ product in 30 milliliter (ml) and 60 ml units’ labels lists the chemical preservatives sodium benzoate and potassium sorbate but do not bear labeling stating that fact, in that the label fails to include a separate description of their function as a preservative in accordance with 21 CFR 101.22(j).
Please respond to this office in writing within 15 working days from your receipt of this letter. Your response should outline the specific steps you are taking or have taken to correct the violations, including an explanation of how your firm plans to prevent these violations from occurring again and copies of related documentation. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete the corrective actions within 15 working days, state the reason for the delay and the time in which you will complete the corrections.
Section 743 of the Act [21 USC 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 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 USC 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 inspected 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.
Your reply should be addressed to the U.S. Food and Drug Administration; Attn: Zada L. Giles, Compliance Officer, via email at ORAHAFEAST5FirmResponses@fda.hhs.gov or at 404 BNA Drive, Suite 500, Nashville, TN 37217. You may reach Ms. Giles at 615-366-7985or via email at Zada.Giles@fda.hhs.gov if you have any questions about this matter.
Sophia V. Nail, Operations Manager
Twinsburg, Ohio 44087-2281