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  1. Warning Letters

WARNING LETTER

Images Unlimited Products, d.b.a. Cellect Products & Oglethorpe, Ltd. MARCS-CMS 591119 —


Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Dietary Supplements

Recipient:
Recipient Name
Mr. Frederic V. Eichhorn
Recipient Title
President
Images Unlimited Products, d.b.a. Cellect Products & Oglethorpe, Ltd.

4747-20 Nesconset Hwy
Port Jefferson Station, NY 11776-2894
United States

Issuing Office:
Division of Human and Animal Food Operations East I

United States


WARNING LETTER
CMS #591119

March 20, 2020


Dear Mr. & Mrs. Eichhorn:

The United States Food and Drug Administration (FDA) conducted an inspection of your facility, located at 4747-20 Nesconset Hwy, Port Jefferson Station, NY 11766 on August 9th, 14th, 16th, and 21st, 2019. In addition, we reviewed product labels for your Essentials Factor brand Cell Synergy Unflavored Powdered Mix, Cell Synergy Chocolate Powdered Mix, Cell Synergy Strawberry Powdered Mix, Cell Synergy Vanilla Powdered Mix, Cell Synergy Capsules with Gelatin, Cod Liver Oil Gel Caps, Olive Leaf Extract with Whole Colostrum Capsules, and Colostrum Capsules. Based on the inspectional findings, a review of your product labels, and a review of your website at the internet address www.essentialsfactor.com, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations.

You can find the Act and the FDA regulations through links in FDA’s website at www.fda.gov (http://www.fda.gov).

Unapproved New Drugs and Misbranded Drugs

You explained to our investigator that (b)(4) of the Unflavored and Flavored Multi-Mineral and Vitamin Blend dietary supplements that you sell are sold in “kits.” These kits include one bottle of Multi-Mineral and Vitamin Blend powder (Essentials Factor brand Cell Synergy Unflavored Powdered Mix, Cell Synergy Chocolate Powdered Mix, Cell Synergy Strawberry Powdered Mix, or Cell Synergy Vanilla Powdered Mix) and one bottle of Cod Liver Oil Gel Caps. Your product labels for these items in the kit provide your website address, www.essentialsfactor.com, where consumers can view more information about “the program” and how they should consume the products in the kit.

FDA reviewed your website at the Internet address www.essentialsfactor.com in February 2020. The claims on your website establish that your kit is a drug under section 201(g)(1)(B) of the Act [21 U.S.C. § 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 kit is intended for use as a drug include:

• Under the header, “Primary Discussion” on the website, the information provided lists recommended servings sizes for Cancerous Conditions and Non-Cancerous Conditions. Per the website, 4 servings of the multi-mineral & vitamin powdered mix taken in conjunction with 4 servings of the cod liver oil gel cap soft gels (“the program” or “the kit”) are suggested for cancerous conditions.

In addition to the above-recommended 4 daily servings to treat cancerous conditions, your website also recommends daily servings of the kit to treat a variety of color-coded non-cancerous conditions, including, but not limited to, the following:

• Autism (denoted in purple font, which indicates a daily dosage amount of 2-3 servings per day),
• Renal Failure (denoted in brown font, which indicates a daily dosage amount of 3-4 servings per day),
• Down’s syndrome (denoted in purple font, which indicates a daily dosage amount of 2-3 servings per day),
• Hypertension (denoted in green font, which indicates a daily dosage amount of 3 servings per day), and
• Metal Poisoning (denoted in red font, which indicates a daily dosage amount of 4 servings per day).

Your website claims also provide evidence that your Olive Leaf Extract with Whole Colostrum Capsules product, whose product label also bears your website, is intended for use as a drug. Under the header, “Olive Leaf Extract” with the sub-header “with Whole Colostrum,” the information provided states the following claims:

• “…Studies have shown each to be extremely valuable in helping combat a wide array of bacterial and viral infections…”
• “Likewise, both olive leaf extract and whole Colostrum have been used successfully by many naturally-oriented physicians and their patients to deal with auto-immune conditions, such as rheumatoid arthritis…”
• “…has been shown to disrupt and even eliminate a wide variety of bacterial and viral infections…”
• “Olive leaf extract also has been proven beneficial in normalizing blood pressure and LDL cholesterol levels, combating inflammatory conditions such as rheumatoid arthritis, fighting allergies, controlling complications of diabetes…”
• “Colostrum work as an efficient team to build an immune system which can fend off any attack, …ranging from speeding the healing of injuries…”
• “…As we are faced with new strains of flu every year, alarming reports of drug-resistant bacteria among us, and an increasing number of allergens in our environment…”
• “Olive Leaf Extract is a natural antibiotic, anti-bacterial, anti-viral & anti-fungal compound”
• “Unlike synthetic antibiotics, olive leaf destroys only the bad bacterial and protects the good. Medical research suggests that when olive leaf extract is taken orally, it searches out and “inactivates” the bacteria. It does this by dissolving outer lining of the infectious germs and then it penetrates the infected cells, thus inhibiting the replication of the bacteria.”
• “Many medical researchers are becoming increasingly concerned about the emergence of super germs that have developed a resistance to antibiotic drugs. (1) Olive leaf extract is increasingly used in Europe as a replacement for synthetic antibiotics. In the USA, olive leaf extract is being used by a growing number of medical practitioners to combat bacteria, viruses, fungi, yeasts and protozoa.”
• “In the USA, olive leaf extract is being used by a growing number of medical practitioners to combat bacteria, viruses, fungi, yeasts, and protozoa. Examples include: strep throat, colds, influenza, pneumonia, ear infections, urinary infections, yeast infections, dental infections, staph infections, severe diarrhea, Tinea, Conjunctivitis, cold sores, Shingles, fibromyalgia, chronic fatigue, Epstein-Barr, Candida, Chlamydia, gonorrhea, meningitis, encephalitis, tuberculosis, food poisoning, E-coli, Salmonella, Herpes, Hepatitis A & B, HIV/AIDS (2), blood poisoning and malaria.”
• “Olive Leaf Extract’s powerful antioxidant may be beneficial against Diabetic complications[:]People with diabetes are likely to develop complications such as retinopathy, nephropathy and neuropathy as a result of oxidative stress and overwhelming free radicals.”
• “Studies show that oleuropein may inhibit hyperglycemia and oxidative stress caused by diabetes and suggests that oleuropin may be helpful in the prevention of diabetic complications associated with oxidative stress.”
• “Some people may experience what is known as Herxheimers Reaction (temporary symptoms include fatigue, diarrhea, muscle and joint pains, headaches, rashes, flu-like symptoms). This is a sign that the olive leaf extract killing a large number of harmful germs quickly…”

The above-listed products are not generally recognized as safe and effective for the above referenced uses and, therefore, this product is a “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 the 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 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” 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 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.

Your Essentials Factor brand Cell Synergy Unflavored Powdered Mix, Cell Synergy Chocolate Powdered Mix, Cell Synergy Strawberry Powdered Mix, Cell Synergy Vanilla Powdered Mix, and Cod Liver Oil Gel Caps (components of “the kit” or “the program”) and your Olive Leaf Extract with Whole Colostrum Capsules 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, these 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 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 Supplement CGMP Violations

Even if the above-mentioned products did not have therapeutic claims which make them unapproved new drugs and/or misbranded drugs, they would be adulterated dietary supplements within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] for the reasons described below. The August 9th, 14th, 16th, & 21st, inspection of your facility revealed serious violations of FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements under Title 21, Code of Federal Regulations, Part 111 (21 CFR 111). These violations cause your dietary supplement products to be adulterated within the meaning of section 402(g)(1) of the Act in that they have been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements

We have received your response, dated September 4, 2019, concerning the observations noted on the Form FDA 483, Inspectional Observations, which was issued to your firm on August 21st, 2019. We address this response below, in relation to each of the noted violations.

1. Your quality control personnel approved and released for distribution a batch of dietary supplement that did not meet established product specifications under 21 CFR 111.70(e), in violation of 21 CFR 111.123(b)(2). Specifically, the finished product Certificate of Analysis, dated 9/24/2018 for Strawberry Flavored Powder Mix, Multi-Mineral & Vitamin Supplement, Lot# (b)(4) documents the finished product heavy metal specification (b)(4). The product was tested (b)(4) and (b)(4). This product was released for distribution (b)(4). In addition, the finished product Certificate of Analysis, dated 5/29/2019 for Unflavored Powder Mix, Multi-Mineral & Vitamin Supplement, Lot# (b)(4) documents the finished product heavy metal specification (b)(4). The product was tested (b)(4) and (b)(4). This product was released for distribution on (b)(4) and (b)(4). These products were released in violation of 21 CFR 111.77(a) as your quality control personnel failed to reject the dietary supplement and permitted their release for distribution.

We have reviewed your written response dated September 4, 2019. You state that you that you will create and implement written quality control procedures for conducting material reviews, create a deviation evaluation procedure, and that you are conducting testing to investigate whether your raw materials and your Strawberry Powders and Unflavored Powders contain organic or inorganic arsenic and the amount of each. We are unable to assess the adequacy of your response because you have not provided documentation to support the aforementioned corrective actions.

2. You failed to prepare a batch production record every time you manufacture a batch of a dietary supplement, as required by 21CFR 111.255(a), and in accordance with 21 CFR 111.260. Specifically, you receive packaged Flavored and Unflavored Powdered Mix, Multi-mineral & Vitamin Supplement & Cod liver soft-gels for your labeling operations at your facility; however, you do not prepare batch production records to document your labeling operation.

We have reviewed your written response dated September 4, 2019, in which you stated that your firm will create and implement Batch Production procedures for creating, printing, distribution and holding of the labels for each of the dietary supplements. We are unable to evaluate the adequacy of your response because you did not provide evidence that you have created and implemented written batch production records to document the labeling operations for your dietary supplement products.

3. You failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement to ensure that the dietary supplement is packaged and labeled as specified in the MMR, as required by 21CFR 111.205(b)(1). Specifically, you receive packaged Flavored and Unflavored Powdered Mix, Multi-mineral & Vitamin Supplement & Cod liver soft-gels for labeling operations at your facility; however, you do not prepare master manufacturing records to document your labeling operation.

We have reviewed your written response dated September 4, 2019, in which you stated that your firm will establish procedures for holding and in-house labeling operations of bottles of dietary supplements. We are unable to evaluate the adequacy of your response because you did not provide evidence that you have established such procedures. We also note that your response didn’t address your failure to have MMRs for how you label your products.

We further note that, as a dietary supplement distributor that contracts with a manufacturer to manufacture a dietary supplement that you distribute under your firm’s name, 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 [see 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.

Although a 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)). 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 enters a contract with other firms to conduct certain dietary supplement manufacturing, packaging, and/or labeling 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.

You receive bulk packaged dietary supplements from a contract manufacturer that manufactures the dietary supplement on your behalf, which you label, hold, and distribute into interstate commerce. As such, 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). As you perform such operations, you must make and keep written documentation, at the time of performance, that quality control personnel perform the review, approval, or rejection requirements, in accordance with 21 CFR 111.140(b)(2).

Misbranded Dietary Supplements

In addition, your dietary supplement products are misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343] because they do not comply with the labeling requirements for dietary supplements, as required by 21 CFR Part 101, for the reasons discussed as follows:

1. Your Essentials Factor brand products including Cell Synergy Unflavored Powdered Mix, Cell Synergy Chocolate Powdered Mix, Cell Synergy Strawberry Powdered Mix, Cell Synergy Vanilla Powdered Mix, Cell Synergy Capsules with Gelatin, Cod Liver Oil Gel Caps, PRP Isolate Spray, Olive Leaf Extract with Whole Colostrum Capsules, and Colostrum Capsules are misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)] because the labels fail to include 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 supplements. “Domestic address or domestic phone number” means a complete address or phone number. The labels for these products do not include a complete address or phone number.

2. Your Essentials Factor brand products – Cell Synergy Powdered Mix (Unflavored, Chocolate, Strawberry, and Vanilla flavors), Cell Synergy Capsules with Gelatin, Cod Liver Oil Gel Caps, PRP Isolate Spray, Olive Leaf Extract with Whole Colostrum Capsules, and Colostrum Capsules – are misbranded within the meaning of Section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)] in that the label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.

3. Your Essentials Factor brand Olive Leaf Extract with Whole Colostrum Capsules product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Specifically, the product label does not provide the source of colostrum.

4. Your Essentials Factor brand Cell Synergy and Powdered Mix (Strawberry and Vanilla flavors), Essentials Factor brand Cell Synergy Capsules with Gelatin, Essentials Factor brand Colostrum Capsules, and Essentials Factor brand and Cellect brand Cod Liver Oil Gel Caps products are 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 does not comply with 21 CFR 101.36. For example,

• Your Essentials Factor brand Cell Synergy Powdered Mix (Strawberry and Vanilla flavors) and Essentials Factor brand Cell Synergy Capsules with Gelatin product labels fail to express the amount of total carbohydrate in the increment specified in 101.9(c)(6). [21 CFR 101.36(b)(2)(i)].
•Your Essentials Factor brand Colostrum Capsules product label fails to express the amount of calories, cholesterol, sodium, potassium, and protein in the increment specified in 101.9(c). [21 CFR 101.36(b)(2)(ii)].
• Your Essentials Factor brand Cell Synergy Powdered Mix (Strawberry and Vanilla flavors) and Essentials Factor brand Cell Synergy Capsules with Gelatin product labels bear an incorrect %DV for magnesium based on the quantitative amount declared per serving in accordance with 21 CFR 111.36(b)(2)(iii).
• Your Essentials Factor brand and Cellect brand Cod Liver Oil Gel Caps product labels present the amount per softgel to the left of the amount per serving (3 softgels). While the quantitative amount by weight and the percent Daily Value of each dietary ingredient may be presented on a "per unit" basis in addition to the "per serving" basis, the "per unit" information must be presented in an additional column to the right of the "per serving" information in accordance with 21 CFR 101.36(e)(9)(i).
• Your Essentials Factor brand and Cellect brand Cod Liver Oil Gel Caps product labels declare cholesterol with an amount of 0 and your Essentials Factor brand Colostrum Capsules product label declares total fat, calories from fat, total carbohydrate, dietary fiber, sugar, vitamin A, vitamin C, and iron with an amount of 0 or an amount that can be declared as zero. Any (b)(2)-dietary ingredient not present, or in an amount that can be declared as zero in 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals) in accordance with 21 CFR 101.36(b)(2)(i).
• Your Essentials Factor brand and Cellect brand Cod Liver Oil Gel Caps product labels declare EPA and DHA with an amount indicated as “amount varies” rather than the quantitative amount by weight per serving as required by 21 CFR 101.36(b)(3)(ii).
• Your Essentials Factor Colostrum Capsules product label fails to declare the quantitative amount of calcium per serving as required by 21 CFR 101.36(b)(2)(i)(A).
• Your Essentials Factor Colostrum Capsules product label fails to list the dietary ingredients in the correct order as required by 21 CFR 101.36(b)(2)(i) and 101.36(b)(3)(i).
• Your Essentials Factor Colostrum Capsules product label fails to express the % Daily Values to the nearest whole percent as required by 21 CFR 101.36(b)(2)(iii)(C).
• Your Cellect brand Powdered Mix (Unflavored and Strawberry flavors) labels bear an incorrect %DV for total carbohydrate based on the quantitative amount declared per serving.

5. Your Essentials Factor brand PRP Isolate Spray product is misbranded within the meaning of section 403(q)(1)(B) of the Act [21 U.S.C. § 343(q)(1)(B)] because the label fails to declare the correct servings per container in accordance with 21 CFR 101.36(b)(1)(ii). The net contents are stated as 150 mL and the serving size is 2 mL; therefore the number of servings per container should be 75.

6. Your Essentials Factor brand PRP Isolate Spray product is misbranded within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because the label does not include a statement of identity as a “dietary supplement” as required by 21 CFR 101.3(g).

We have reviewed your written response dated September 4, 2019; however, your response does not specifically address these violations.

The violations cited in this letter are not intended to be all-inclusive list 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 all products marketed by your firm comply with the Act and its implementing regulations. You should take prompt action to correct the violations cited in this letter. Failure to correct these violations may result in legal enforcement action without further notice, including, without limitation, seizure and/or 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 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 corrective actions 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 re-inspection-related costs. A re-inspection 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. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection 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.

Your written reply should be directed to the U.S. Food and Drug Administration, Attention: Michael R. Dominick, Compliance Officer, 222 Bloomingdale Road, Suite 406, White Plains, NY 10601. If you have questions regarding any issues in this letter, please contact Michael R. Dominick at 914-682-2826 or email at Michael.Dominick@fda.hhs.gov.

Sincerely,
/S/

Ronald Pace
Program Division Director
Office of Human and Animal Food Operations East – Division 1