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  1. Compliance Actions and Activities

WARNING LETTER

1ViZN LLC MARCS-CMS 522724 — 23/08/2017

1ViZN LLC - 522724 - 08/23/2017

Product:
Dietary Supplements
Drugs

Recipient:
Recipient Name
M. Bruce Davis
Recipient Title
Founder and President
1ViZN LLC

1180 N Mountain Springs Parkway
Springville, UT 84663
United States

Issuing Office:
Division of Human and Animal Food Operations West IV

1 Denver Center, Building 20, Denver Federal Center
Denver, CO 80225-0087
United States


August 23, 2017

 

WARNING LETTER

VIA UPS OVERNIGHT

 

M. Bruce Davis

Founder and President

1ViZN LLC

1180 N Mountain Springs Parkway

Springville, UT 84663

 

Ref: # DEN-17-16-WL

 

Dear Mr. Davis:

On February 21, 23, 27, and 28, 2017, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 1180 N Mountain Springs Parkway, Springville, Utah.  Based on our inspection and subsequent review of your product labeling, including your firm’s website, we found serious violations of the Federal Food, Drug and Cosmetic Act (the Act). You can find the Act and FDA regulations through links on FDA’s website at www.fda.gov.

Unapproved New Drugs

FDA reviewed your website at the internet address https://1vizn.com/1vizn-homepage/ in August 2017 and has determined that you take orders there for 1ViZN products, including Amazon PowrBlend. The claims on your website 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.

Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:

The Amazon PowrBlend under “Select an Ingredient to Learn More”: 

  • Apple - Apple – “[H]elp reduce tooth decay and risk of diabetes…reduces cholesterol, helps prevent gallstones, neutralizes irritable bowel syndrome….”
  • Cupuacu – “Contains Anti-Inflammatory Properties”
  • Blueberry – Blueberry – “[L]ower risk factors for cardiovascular disease and metabolic syndrome. The high vitamin content reduces inflammation…lessening depression.”
  • Camu Camu – “[A]cting as an Anti-Diabetic…Contains Natural Anti-Inflammatory Properties”
  • Grapes – “Adding moisture to the lungs helps ease asthma…often used as a home remedy for reducing migraines…They contain antibacterial and antiviral properties, helping prevent infections and illness.”
  • Mango – “[I]t helps lower cholesterol…normalizes insulin levels to moderate sugar levels in diabetics….”
  • Pineapple – “[A]cts as an anti-inflammatory…lowers risk of macular degeneration (primary cause of vision loss in adults), and alleviates arthritis.”
  • Pomegranate – “[L]owers cholesterol and blood pressure, relieves depression, and inhibits abnormal platelet aggregation – helping to prevent heart attacks, strokes....”

Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of products for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials found under the 1ViZN “Results” link, include:

SUCCESS STORY | LEANN

  • “[S]evere joint pain due to RA...pain in jaw caused from TMJ…taking…The Amazon PowrBlend daily…reduced pain in wrists, fingers, and hip and my jaw pain are [sic] gone…”

SUCCESS STORY | PAYTON

  • “[S]uffers from severe ADD…try 2 Amazon PowrBlend a day…able to focus without the need of meds…”

SUCCESS STORY | SARAH

  • “[D]iagnosed with Juvenile Rheumatoid Arthritis…officially pain free and off all of [medications] with her Pediatric Rheumatologists ok…only thing Sarah is taking now is The Amazon PowrBlend.”

SUCCESS STORY | CASSANDRA

  • “I have always had many female medical problems including Endometriosis and Ectopic Pregnancy. These medical issues caused me to go into a really bad depression and I suffered from a lot of pain. Since I started taking 1ViZN products…I have noticed I rarely have pain anymore.”

SUCCESS STORY | KATHY

  • “I have been able to go off my depression medication, [sic] I haven’t had bronchitis since February of 2014…”

SUCCESS STORY | BROOKE

  • “I’ve suffered the worsening pain of Fibromyalgia for many years…the 1ViZN products have reduced my swelling, and my pain, which should be almost unbearable in the cold season, has truly been cut in half and they are the only things I am taking.”

SUCCESS STORY | LISA

  • “In August of 2013, my husband brought home a sample of Velocity…and my depression was gone.”

SUCCESS STORY | TRICIA

  • “For 30 years, I have struggled with High Blood Pressure and Hyperthyroidism. I take medication daily for both. For the last couple years, my teeth have been mobile and bleed a lot during cleanings. Since I have started taking the 1ViZN products, my Blood Pressure has started dropping and my Thyroid started increasing…I am now on 1/4 of a Blood Pressure pill daily and my Endocrinologist has decreased my Thyroid dosage.

SUCCESS STORY | JUDI

  • “My cholesterol had gone down 11 points!”

SUCCESS STORY | LEROY

  • “My last blood work showed my cholesterol at 168 and that is the first time in my life that it has been under 200. My blood pressure runs around 110/64 and my sugar levels are in the 90-‐110 range in the mornings.”

SUCCESS STORY | MANDY

  • “[I] started noticing something different in my eating disordered thinking…suddenly I no longer felt the urge to purge and the constant flurry of “food thoughts” were gone.  I have been taking Velocity for about 5 months and am happy to say I have exhibited ZERO eating disorder behaviors in that time…”

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 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” 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 Amazon PowrBlend and use of other 1ViZN products (not specifically identified) are intended for treatment of one or more diseases that are not amendable 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, Amazon PowrBlend and your other 1ViZN 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 Supplements

Even if your Amazon PowrBlend and 1ViZN products (not specifically identified) did not have therapeutic claims which make them unapproved new drugs, these products, along with your ReVive Core, ReVive Hard-Core, and Ignite Metabolic Burn products, would still be adulterated dietary supplements under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not meet the Current Good Manufacturing (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). The following CGMP violations were observed during the inspection:

1.    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, during the inspection you stated you rely on your contract manufacturers to handle quality control and you do not have any quality control procedures in place. Once you have established your written procedures for the responsibilities of quality control, you must implement quality control operations into your holding operations, as required by 21 CFR 111.65. Further, you must have documentation of the quality control personnel review and approval for release of any packaged and labeled dietary supplement (21 CFR 111.127(h) and 111.140(b)(2)).

You receive finished, packaged and labeled dietary supplements from a manufacturer that manufactures the dietary supplements on your behalf (your contract manufacturer). To the extent that another firm manufactures dietary supplements on your behalf as a contract manufacturer that your firm releases for distribution under your firm’s name, your firm has an obligation to know what and how manufacturing activities are performed so that you can make decisions related to whether your dietary supplement products conform to established specifications and whether to approve and release the products for distribution. [72 Fed. Reg. 34752, 34790 (Jun. 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 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).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)).

2.     You failed to collect and hold reserve samples of each lot of packaged and labeled dietary supplement that you distribute, as required by 21 CFR 111.83. Specifically, during the inspection you stated to our investigator that your company does not hold any reserve samples of product.

3.    You failed to establish and follow written product complaint handling procedures, as required by 21 CFR 111.553. Specifically, during the inspection it was observed that you do not have established written procedures for product complaints. You provided our investigator a draft procedure for product complaints; however, the procedure was not finalized by the close of the inspection.

4.    You failed to establish and follow written procedures for holding and distribution operations, as required by 21 CFR 111.453. Specifically, your firm receives finished product that you hold and distribute to your customers. During the inspection it was observed that you do not have written procedures for your holding and distributing operations.

5.    You failed to establish and follow written procedures to fulfill the requirements for returned dietary supplements, as required by 21 CFR 111.503. Specifically, during the inspection it was observed that you have no written procedures for returned dietary supplements.

New Dietary Ingredient

Further, because you have not submitted a required notification for new dietary ingredients, your Ignite Metabolic Burn product is adulterated under sections 402(f)(1)(B) and 413(a) of the Act (21 U.S.C. 342(f)(1)(B) and 350b(a)). Based on FDA laboratory results, it has come to our attention that Bitter Orange (Citrus aurantium) extract in your Ignite Metabolic Burn product contains (b)(4)% p-synephrine (which is significantly higher compared to naturally occurring bitter orange (Citrus aurantium) that contains p-synephrine levels of about 0.1–0.3%, or ~1–3 mg/g).  We have found that p-synephrine is a constituent of the ingredient, Bitter Orange (Citrus aurantium) extract, listed on the label for the Ignite Metabolic Burn Product.  Section 201(ff)(1) of the Act [21 U.S.C. § 321(ff)(1)] defines the term “dietary ingredient” as a vitamin, mineral, amino acid, herb or other botanical, or dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract or combination of any dietary ingredient from the preceding categories.  A dietary supplement which contains bitter orange extract with (b)(4)% p-synephrine qualifies as a dietary ingredient. 

Under section 413 of the Act [21 U.S.C. § 350b], a dietary supplement that contains a new dietary ingredient (i.e., a dietary ingredient not marketed in the United States before October 15, 1994) shall be deemed adulterated under section 402(f) of the Act [21 U.S.C. § 342(f)] unless it meets one of two requirements:

1.    The dietary supplement contains only dietary ingredients that have been present in the food supply as an article used for food in a form in which the food has not been chemically altered; or

2.    There is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides FDA with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.

To the best of FDA’s knowledge, there is no information demonstrating that Bitter Orange Extract (p-synephrine (b)(4)%) was lawfully marketed as a dietary ingredient in the United States before October 15, 1994, nor is there information demonstrating that this ingredient has been present in the food supply as an article used for human food in a form in which the food has not been chemically altered. In the absence of such information, Bitter Orange Extract (p-synephrine (b)(4)%) is subject to the notification requirement in section 413(a)(2) of the Act (21 U.S.C. 350b(a)(2)) and 21 CFR 190.6. Because the required notification has not been submitted, your product is adulterated under sections 402(f)(1)(B) and 413(a) of the Act.

Even if the required notification had been submitted, we know of no evidence that would establish that your product is not adulterated. To the best of FDA’s knowledge, there is no history of use or safety establishing that Bitter Orange (Citrus aurantium) extract containing (b)(4)% p-synephrine will reasonably be expected to be safe when used as a dietary ingredient. In the absence of a history of use or other evidence of safety establishing that Bitter Orange (Citrus aurantium) extract containing (b)(4)% p-synephrine when used under the conditions recommended or suggested in the labeling of your products, will reasonably be expected to be safe, your product containing Bitter Orange (Citrus aurantium) extract containing (b)(4)% p-synephrine is adulterated under sections 402(f)(1)(B) and 413(a) of the Act because it contains a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. Introduction of such products into interstate commerce is prohibited under sections 301(a) and (v) of the Act [21 U.S.C. 331(a) and (v)]. 

Misbranded Dietary Supplements

Further, your Amazon PowrBlend, ReVive Core, ReVive Hard-Core, and Ignite Metabolic Burn products are misbranded dietary supplements under 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 101.

  • The Amazon PowrBlend product is misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)] because the label is false and misleading in that the label claims “2,000% RDA vitamin C” whereas the declared amount per serving is 1,000% DV.
  • The Amazon PowrBlend and Ignite Metabolic Burn products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product 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. For example:
    • The Ignite Metabolic Burn product label fails to list the ingredients used to form the veggie capsule as required by 21 CFR 101.4(g).
    • The Amazon PowrBlend product declares the dietary ingredients cupuacu and EpiCor, but these are not the common or usual name for these dietary ingredients.
    • The Ignite Metabolic Burn product declares the dietary ingredients EGCG, Flo-Gard, BioPerine, and cupuacu, but these are not the common or usual name for these dietary ingredients.
  • The Amazon PowrBlend is misbranded within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because your product label fails to identify the product by using the term “dietary supplement” in accordance with 21 CFR 101.3(g), which requires that a dietary supplement be identified by the term “dietary supplement” as part of the product’s statement of identity, except the word “dietary” may be deleted and replaced by the name of the dietary ingredient in the product or an appropriate descriptive term.
  • The Amazon PowrBlend, Ignite Metabolic Burn, Revive Core, and ReVive Hard-Core products are 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).
  • The Amazon PowrBlend is misbranded within the meaning of section 403(q)(1)(A) [21 U.S.C. § 343(q)(1)(A)] because the serving size on the label is incorrect. The terms “serving” or “serving size” for a dietary supplement are defined in 21 CFR 101.9(b) and 101.12, Table 2, as the maximum amount recommended on the label for consumption per eating occasion. The label states the serving size is “2 Stick Pack (10g)” while the directions indicate to “Tear open 1 packet…and pour entire contents of packet into mouth and eat, repeat twice daily.”
  • The Amazon PowrBlend, Ignite Metabolic Burn, Revive Core, and ReVive Hard-Core 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:
  • The Amazon PowrBlend product is misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] in that the label bears a nutrient content claim, but the product does not meet the requirements to bear the claim.  Under section 403(r)(1)(A) of the Act, a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation promulgated by the Secretary (or by delegation, FDA) authorizing the use of such a claim. Characterizing the level of a nutrient in food labeling of a product without complying with the specific requirements pertaining to nutrient content claims for that nutrient misbrands the product under section 403(r)(1)(A) of the Act. Specifically,  the labelfor your Amazon PowrBlend product claims “packed with antioxidants.”. The term “packed with” is a nutrient content claim because it characterizes the level of nutrients in your product [see section 403(r)(1)(A) of the Act and 21 CFR 101.13(b)].  However, FDA has not authorized the use of a nutrient content claim using the term “packed with.” 

Further, even if FDA authorized the term "packed with," nutrient content claims using the term "antioxidant" must also comply with the requirements listed in 21 CFR 101.54(g). These requirements state, in part, that for a product to bear such a claim, an RDI must have been established for each of the nutrients that are the subject of the claim [21 CFR 101.54(g)(l)], and these nutrients must have recognized antioxidant activity [21 CPR 101.54(g)(2)]. The level of each nutrient that is the subject of the claim must also be sufficient to qualify for the claim under 21 CFR 101.54(b), (c), or (e) [21 CFR 101.54(g)(3)]. For example, to bear the claim "high in antioxidant vitamin C," the product must contain 20 percent or more of the RDI for vitamin C under 21 CFR 101.54(b ). Such a claim must also include the names of the nutrients that are the subject of the claim as part of the claim or, alternatively, the term "antioxidant" or "antioxidants" may be linked by a symbol ( e.g., an asterisk) that refers to the same symbol that appears elsewhere on the same panel of the product label, followed by the name or names of the nutrients with recognized antioxidant activity [21 CFR 101.54(g)(4)]. Your claim "packed with antioxidants" does not meet the requirements to make an antioxidant nutrient content claim under section 101.54(g), in part because the claim does not include, or refer to, the names of any nutrient(s) with recognized antioxidant activity.

  • The Ignite Metabolic Burn, Revive Core, ReVive Hard-Core, and Amazon PowrBlend products are misbranded within the meaning of Section 403(r)(6) of the Act [21 U.S.C. §343(r)(6)] because the label makes structure function claims but fails to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b).  Under section 403(r)(6) of the Act, a dietary supplement may bear certain claims, generally called "structure/function claims," on its label or in its labeling provided that the firm has substantiation that the claim is truthful and not misleading; the firm has notified FDA within 30 days of marketing the product bearing the claim; and the claim includes a mandatory disclaimer.  For example:
    • The Amazon PowrBlend and Ignite Metabolic Burn fail to bear the required disclaimer.
    • The Revive Core and ReVive Hard-Core product labels do not bear a symbol next to all structure/function claims linking the claims to the disclaimer.
  • The Amazon PowrBlend is misbranded within the meaning of section 403(s)(2)(A)(ii)(II) and 403(q)(5)(F)(ii) of the Act [21 U.S.C. § 343(s)(2)(A)(ii)(II) and 343(q)(5)(F)(ii)] in that the label fails to list "other dietary ingredients" in the "Supplement Facts" label following the listing of dietary ingredients having Daily Values, in accordance with 21 CFR 101.36(b)(3)(i). In addition, you must list the total weight of all "other dietary ingredients" contained in the proprietary blend. These ingredients should be followed by a symbol referring to the footnote "Daily Value Not Established", as required by 21 CFR 101.36(b)(2) and (c).
  • The Ignite Metabolic Burn, Revive Core, and ReVive Hard-Core products are misbranded within the meaning of sections 403(s)(2)(A)(ii) and 403(q)(5)(F)(ii) of the Act [21 U.S.C. § 343(s)(2)(A)(ii) and 343(q)(5)(F)(ii)] in that the label fails to include the quantitative amount by weight per serving size of all the dietary ingredients, as required by 21 CFR 101.36. For example:
    • The Ignite Metabolic Burn label fails to include the quantitative amount by weight per serving size of all the listed dietary ingredients.
    • The Revive Core and ReVive Hard-Core products contain ingredient information to suggest that your product contains niacin and vitamin B-12. You do not list these (b)(2)-dietary ingredients in a separate section above the (b)(3)-dietary ingredients in the Supplement Facts label and you do not list the quantitative amount by weight per serving in accordance with 21 CFR 101.36(b)(2) and 101.36(c)(1).
  • The Amazon PowrBlend is 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(a).
  • The Amazon PowrBlend is misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] in that the label fails to bear a declaration of the net quantity of contents, in accordance with 21 CFR 101.7(a). 
  • The Amazon PowrBlend is misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person as described in section 761(b) of the Act [21 U.S.C. C 379AA-1] may receive a report of a serious adverse event with such dietary supplement. A domestic address or domestic phone number indicates a complete address or phone number. The label for this product does not include a complete address or phone number.

The above violations are not intended to be an all-inclusive list of violations at your facility or that exist in connection with your products.  It is your responsibility to ensure that all the products you manufacture or distribute comply with the Act and its implementing regulations.  You should take prompt action to correct the violations cited in this letter.  Failure to promptly correct these violations may result in enforcement action without further notice, such as seizure and/or injunction.

In addition, we offer the following comments:

  • The Amazon PowrBlend, Ignite Metabolic Burn, Revive Core, and ReVive Hard-Core products do not contain the heavy bars as required by 21 CFR 101.36(e)(6). A heavy bar shall be placed beneath the last dietary ingredient to be listed, if any, and beneath the last other dietary ingredient to be listed, if any.
  • The Ignite Metabolic Burn, Revive Core, and ReVive Hard-Core product label’s information panel includes nutrition or ingredient information intermingled with information that is considered intervening material. Examples of intervening material are the statements of “No GMOs. Gluten Free,” “Energy boost duration varies per person,” “C.J.C.D = Caye-ject Cellular Delivery System,” and “Dietary supplement” [21 CFR 101.2(e)].
  • The Ignite Metabolic Burn, Revive Core, and ReVive Hard-Core labels bear an erroneous statement, “**% Daily Value not established,” and the asterisks do not refer to any dietary ingredient [21 CFR 101.36(b)(3)(iv)].
  • The Amazon PowrBlend product label bears the statement, “**Percent Daily Values (DV) are based on a 2,000 calorie diet,” the asterisks do not refer to any dietary ingredient [21 CFR 101.36(b)(2)(iii)(D)].
  • The Revive Core and ReVive Hard-Core labels bear Other Ingredients within the Supplement Facts label. The ingredient list must be separate from the Supplement Facts.
  • Any expiration date, shelf life, or “Best by” date you place on a product label should be supported by stability data [See 72 Fed. Reg. 34752, 34856 (Jun. 25, 2007)].  The term “shelf life dating” includes expiration dating” and “best if used by” dating [See 72 Fed. Reg. 34752, 34912 (Jun. 25, 2007)].  You informed our investigator that you use a (b)(4) expiration date on your Revive Core, and ReVive Hard-Core dietary supplements; however, you do not have any stability testing data to support this date.

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 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.

Please respond to this letter in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct the violations listed above and to prevent similar violations in the future.  Your response should include any documentation necessary 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.

Your written response should be addressed to the U.S. Food and Drug Administration; Attn: Hanna L. Potter, Compliance Officer; P.O. Box 25087, Denver, Colorado, 80225-0087. You may reach Ms. Potter at (303) 236-3094 if you have any questions regarding any issues in this letter.

 

Sincerely,

/S/ 

LaTonya M. Mitchell

Program Division Director

Office of Human and Animal Food Operations –

Division IV West

 

 

Cc:       Associate Director

            Division of Advertising Practices

            Federal Trade Commission

            600 Pennsylvania Avenue, NW

            Washington, DC 20580