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  5. Golden Lab LLC - 625783 - 05/26/2022
  1. Warning Letters

WARNING LETTER

Golden Lab LLC MARCS-CMS 625783 —

Delivery Method:
Via Email
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
Dr. Howard J. Loff, M.D.
Recipient Title
Owner and CEO
Golden Lab LLC

2375 Saint Johns Bluff Rd S Ste 310
Jacksonville, FL 32246-2335
United States

Hloffmd@doctorsoptimalformula.com
Issuing Office:
Office of Human and Animal Food Operations East Division IV

United States

WARNING LETTER

May 26, 2022

22-HAFE4-WL-05/CMS No. 625783

Dear Mr. Loff:

This is to advise you that the U.S. Food and Drug Administration conducted an inspection of your facility, located at 2375 Saint Johns Bluff Rd S Ste 310, Jacksonville, Florida, on November 1, 2, 3 and 10, 2021. Based on our inspection and our review of labeling collected during the inspection, we identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act). You may find the Act and the FDA’s regulations through links on FDA’s home page at http://www.fda.gov.

Unapproved New Drugs and Misbranded Drugs

During the inspection, our investigators reviewed your product labels and your website at www.doctorsoptimalformula.com, from which website you take orders for your DoctoRx’s Optimal Formula Ocular Pressure & Optic Nerve Support Formula Ocular Health Capsule, DoctoRx’s Optimal Formula Meso Plus Astaxanthin Ocular Support Capsule, and Alereve Seasonal Allergy Support Ocular Health Capsule. The claims on your product labels and website establish that the products are drugs within the meaning of 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.

Examples of some of the claims observed on your product labels and website that provide evidence that your products are intended for use as drugs include:

Product: DoctoRx’s Optimal Formula Ocular Pressure & Optic Nerve Support Formula Ocular Health Capsul

On your product label:
    “Take if suffering from glaucoma or ocular hypertension”
    “Reduces IOP & Increases Blood Flow”
    “DoctoRX’s formula”

On your website:
    “Our ocular Pressure & Optic Nerve Support Formula was designed specifically for patients suffering from glaucoma, ocular hypertension, or those with a strong family history of glaucoma.”
    “MitrogenolTM is clinically proven to reduce intraocular pressure by up to 25% without the side effects.”

Product: DoctoRx’s Optimal Formula Meso Plus Astaxanthin Ocular Support Capsule

On your product label:
    “Reduces risks of photochemical damage from effects of Blue Light”
    “DoctoRX’s formula”

On your website:
    “This constant bombardment from cell phones, tablets, computers, televisions, etc. poses a particular threat to those either suffering from or with a predisposition to Macular Degeneration.”
    “For those with genetic predisposition to AMD [Age-Related Macular Degeneration], and in addition with a history of smoking, family history of AMD, or lightly-colored eyes should vigorously protect themselves from the risks associated with screen addiction and blue light. Meso Plus Astaxanthin contains the essential nutrients necessary, and should be included in the diet for those susceptible”

Product: Alereve Seasonal Allergy Ocular Support Capsule

On Product label:
    “Relief from symptoms associated with ocular allergies and sinus pressure”
    “Relief from Symptom of OSD [Ocular Surface Disease] *Without the Side Effects of Antihistamines”

On your website:
    “Developed by leading Ophthalmologists specializing in allergies, Alereve has developed an all-natural, proprietary blend that is positioned to be the therapy of choice for patients with ocular allergies, treating the patient’s underlying allergic condition without the unwanted side-effects of dryness.”
    “Alereve was developed to better treat patients’ ocular allergies without exacerbating their dry eye component in fact, our initial study demonstrated that some patient’s Dry Eye Syndrome was significantly improved with Alereve treatment”

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)]. With certain exceptions not applicable here, 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.

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 DoctoRx’s Optimal Formula Ocular Pressure & Optic Nerve Support Formula Ocular Health Capsule and DoctoRx’s Optimal Formula Meso Plus Astaxanthin Ocular Support Capsule 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 DoctoRx’s Optimal Formula Ocular Pressure & Optic Nerve Support Formula Ocular Health Capsule and DoctoRx’s Optimal Formula Meso Plus Astaxanthin Ocular Support Capsule 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)].

Dietary Supplement cGMP Violations

During the inspection, our investigators found significant violations of the current Good Manufacturing Practice (cGMP) regulations for dietary supplements, Title 21 Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations render dietary supplements manufactured at your facility to be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. §342(g)(1)] in that the dietary supplements have been prepared, packed, or held under conditions that do not meet cGMP regulations for dietary supplements. Additionally, even if your DoctoRx’s Optimal Formula Ocular Pressure & Optic Nerve Support Formula Ocular Health Capsule, DoctoRx’s Optimal Formula Meso Plus Astaxanthin Ocular Support Capsule, and Alereve Seasonal Allergy Support Ocular Health Capsule were not unapproved new and/or misbranded drugs as described previously in this letter, these products would be adulterated dietary supplements. Our investigators’ observations were noted on form FDA-483, Inspectional Observations, which was issued to you on November 10, 2021, and amended on November 16, 2021.

Our investigators identified the following significant violations:

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 contaminants 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, you have no such specifications for your DoctoRx’s Optimal Formula Dry Eye Formula Ocular Support Softgel, DoctoRx’s Optimal Formula Ocular Pressure & Optic Nerve Support Formula Ocular Health Capsule, DoctoRx’s Optimal Formula Meso Plus Astaxanthin Ocular Support Capsule, and Alereve Seasonal Allergy Support Ocular Health Capsule.

We have reviewed your response, dated November 29, 2021. Your response included a finished product specification sheet for your DoctoRx’s Optimal Formula Meso Plus Astaxanthin Ocular Support Capsule product titled “Specifications Document #: GLSOP-400 Revision 4 Effective date Jan 14 2021,” a finished product specification monitoring form that did not identify the intended product or intended testing, and an Excel spreadsheet that you assert demonstrates training was performed related to specifications. The finished product sheet for your DoctoRx’s Optimal Formula Meso Plus Astaxanthin Ocular Support Capsule product did not contain specifications for strength, concentration, or purity. It also lists a specification of “Positive” for the (b)(4) ((b)(4)) method. Positive is not a viable specification for the use of the (b)(4) method. In addition, you list “Input” for the method regarding several of the dietary ingredients in this product. Input is not an acceptable method for determining finished product specifications have been met.

2. You failed to establish the component specifications to ensure the purity, strength, and composition for the dietary supplements are met, as required by 21 CFR 111.70(b)(2). Specifically, you failed to establish component specifications for the components Grape Seed Extract Blackcurrant “Fuit [sic]” Powder (Blackcurrant Fruit Powder), Curcumin 95%, Astaxanthin 5%, and Meso-Zeaxanthin 60% used in the manufacture of your DoctoRx’s Optimal Formula Meso Plus Astaxanthin Ocular Support Capsule, DoctoRx’s Optimal Formula Ocular Pressure & Optic Nerve Support Formula Ocular Health Capsule, and Alereve Seasonal Allergy Support Ocular Health Capsule.

Once you have established these specifications, you must determine whether the specifications that you establish under 21 CFR 111.70 are met, as required by 21 CFR 111.73 and 21 CFR 111.75(c). Specifically, before using a component, you must conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, as required by 21 CFR 111.75(a)(1)(i), unless you petition the agency under 21 CFR 111.75(a)(1)(ii) and the agency exempts you from such testing. You must also confirm the identity of other components and determine whether other applicable component specifications established in accordance with 21 CFR 111.70(b) are met, as required by 21 CFR 111.75(a)(2). Further, you must verify that your finished batch of the dietary supplement meets product specifications for the identity, purity, strength, composition, and for limits on those types of contamination that may adulterate or that lead to adulteration of the finished batch of the dietary supplement, as required by 21 CFR 111.75(c). You must also make and keep records, including records for the specifications you establish, in accordance with 21 CFR 111.95.

We have reviewed your response, dated November 29, 2021. Your response stated you are developing component specifications but did not provide any evidence of this corrective action.

3. Your batch production records (BPRs) did not include complete information relating to the production and control of each batch, as required by 21 CFR 111.255(b) and 21 CFR 111.260. Specifically, your BPRs for your DoctoRx’s Optimal Formula Ocular Pressure & Optic Nerve Support Formula Ocular Health Capsule, DoctoRx’s Optimal Formula Meso Plus Astaxanthin Ocular Support Capsule, and Alereve Seasonal Allergy Support Ocular Health Capsule failed to include the following information:

  • Documentation, at the time of performance, that quality control approved and released, or rejected, the batch for distribution, including any reprocessed batch [111.260(l)(3)].
  • Documentation, at the time of performance, of the manufacture of the batch, including the date on which each step of the master manufacturing record was performed and the initials of the persons performing each step, including the initials of the person responsible for weighing or measuring each component used in the batch, the person responsible for verifying the weight or measure of each component used in the batch, the initials of the person responsible for adding the component to the batch, and the initials of the person responsible for verifying the addition of components to the batch [21 CFR 111.260(j)].

We have reviewed your response, dated November 29, 2021. Your response included a procedure for maintaining of BPRs as well as two parts of an executed BPR for your DoctoRx’s Optimal Formula Meso Plus Astaxanthin Ocular Support Capsule product for a batch size of 50,000. Your response also stated that “[t]he anticipated completion date for this corrective action December 31, 2022.” Based on the incomplete BPRs provided we are unable to evaluate the sufficiency of your corrective action.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

We also note that your product Hourzzz Sublingual Drops, which is marketed as a dietary supplement, bears directions for use as a sublingual product. However, the Act defines the term “dietary supplement” in section 201(ff)(2)(A)(i) of the Act [21 U.S.C. § 321(ff)(2)(A)(i)] as a product that is “intended for ingestion.” Because sublingual products are intended to enter the body directly through the skin or mucosal tissues, they are not dietary supplements.

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any 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 actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Your written response should be directed to the Food and Drug Administration, attention to: Mr. Ramon Hernández, District Director, 466 Fernández Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions regarding this letter, please contact, Ms. Marilyn Santiago, Compliance Officer, at (787) 729-8707 or via email at Marilyn.santiago@fda.hhs.gov.

Sincerely,
/S/

Ramon A. Hernandez
District Director | FDA San Juan District
Program Division Director
Office of Human and Animal Food Operations-
East Division 4

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