January 30, 2019
Via UPS Overnight
Dr. Patrick Flanagan
Owner, Phi Sciences
271 S. Airpark Rd.
Cottonwood, AZ 86326
Ref: # HAF4W-19-04-WL
Dear Dr. Flanagan:
From August 10-18, 2018, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 271 S. Airpark Road, Cottonwood, Arizona. Based on the inspectional findings, a review of the product labels collected during the inspection, and a review of your website at www.phisciences.com, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You may find the Act and FDA regulations through links on FDA’s website at www.fda.gov.
Unapproved New Drugs/Misbranded Drugs
FDA reviewed your website at the Internet address www.phisciences.com in September 2018 and has determined that you take orders there for the following products: Mega Hydrate Powder, Mega Hydrate Capsules, and Crystal Energy. FDA also reviewed product labels collected during the August 2018 inspection. The claims on your website establish that these products are drugs under section 201(g)(1)(B) of the Act [21 USC 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:
Mega Hydrate products:
- “MegaHydrate is the key that unlocks the potential of water as the medium for nutrient replenishment and waste removal at the cellular level. In a state of dehydration, body cells cannot assimilate nutrients and remove waste and relief pain from conditions like arthritis orfibromyalgia. Dehydration also occurs as a side effect of caffeine. Caffeine effects include anxiety, headaches, sleep disorders, and many common ailments….”
- “MegaHydrate also helps fight the negative effects of alcohol…”
Your website contains evidence of intended use in the form of personal testimonials recommending or describing the use of Crystal Energy and Mega Hydrate products for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:
- “I suffered from Classic Migraine headaches since age 13… I learned about your products through a Chiropractor friend who was literally snatched from the jaws of death after she became afflicted with Typhoid fever…She was so dehydrated the doctors could not get an IV into her, so went home to die. A client called her and after she explained her condition, the client took her a 4 oz container of Crystal Energy. She claims to have been able to work after taking it in an hour....”
- “I went into the aura phase of a migraine. Immediately, I took four MegaHydrine and the symptoms went away…”
- “[A]s I understand it, migraines are very similar to strokes. The blood has thickened to the point that a migraine saves the person from death by opening up the blood vessels in the brain. If this is the case, MegaHydrin may be a treatment for strokes!..”
- “I reached Dr. Flanagan and asked him about taking the mega H, telling him that I had hep C. from a blood transfusion 20 years earlier. I told him my viral load then was 12 million. He advised me to take 6 mega H. I did as he suggested…after 9 months of taking it, my viral load was 1 million…”
- “I would like to relate my experience regarding Mega H. I have been subject to migraines for most of my life…If a migraine occurs, I can flush my system with water and Mega H-, and most of the pain goes away, if not curing the migraine outright…Prevention of migraines, tho, seems to be the greatest part…”
Your Crystal Energy and Mega Hydrate 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)(1) of the Act [21 USC 321(p)(1)]. 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), 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 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 Mega Hydrate 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 these products safely for their intended purposes.
Accordingly, your Mega Hydrate 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)].
Dietary Supplement CGMP Violations
Your dietary supplement products are adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] because the products have been prepared, packed, or held under conditions that do not meet the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111). Additionally, even if your website did not contain therapeutic claims that render your Crystal Energy and Mega Hydrate products unapproved new drugs, these products would be adulterated dietary supplements within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] because the products have been prepared, packed, or held under conditions that do not meet the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111).
During the inspection of your facility, our investigator observed the following significant violations of CGMP requirements:
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, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103. Specifically, during the inspection it was observed that you do not have any written quality control operations in place to perform quality control functions.
To the extent that another firm manufactures, packages, and/or labels your dietary supplements on your behalf that your firm releases for distribution under your firm’s name, your firm has an obligation to know what and how manufacturing, packaging, and/or labeling 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, packaging, and/or labeling 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).
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 contracts out some or all of its operations must establish a system of production and process controls to 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 111.55). The 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). Further, your firm 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 21 CFR 111.140(b)(2).
We have reviewed your response dated October 5, 2018; however, we are unable to evaluate the sufficiency of your corrective actions. Your response stated that you are creating a procedure manual to include “all Standard Operating Procedures as listed in Title 21 of the FDA regulations.” We will evaluate the sufficiency of your written procedures for your quality control operations during our next inspection.
2. You failed to establish and follow written procedures for the responsibilities for holding and distributing operations, as required by 21 CFR 111.453. Specifically, you informed our investigator that you did not have written procedures for holding and distributing operations of your dietary supplement products.
We have reviewed your response dated October 5, 2018; however, we are unable to evaluate the sufficiency of your corrective actions. Your response stated that you are creating a procedure manual to include “all Standard Operating Procedures as listed in Title 21 of the FDA regulations.” We will evaluate the sufficiency of your written procedures for holding and distribution operations during our next inspection.
Misbranded Dietary Supplements
Additionally, even if your website did not contain therapeutic claims that render your Crystal Energy and Mega Hydrate products unapproved new drugs, your Crystal Energy, Mega Hydrate Powder, and Mega Hydrate Capsule products are misbranded within the meaning of section 403 [21 U.S.C. § 343] of the Act because they do not comply with the labeling requirements for dietary supplements as required by 21 CFR 101.
1. Your Crystal Energy, Mega Hydrate Powder, and Mega Hydrate Capsule products are misbranded within the meaning of Section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)] in that the labels fail to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.
2. Your Mega Hydrate Powder product is misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] for failing to declare the net quantity of contents in terms of avoirdupois pound and ounce as required by 21 CFR 101.7(b)(1) and 15 USC 1453(a) of the Fair Packaging and Labeling Act (FPLA) [15 U.S.C. §1453(a)]. Furthermore, the term "net weight" shall be used when stating the net quantity of contents in terms of weight, in accordance with 21 CFR 101.7(j)(3).
3. Your Mega Hydrate Powder and Mega Hydrate Capsule products are misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving size declared on the label is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Specifically:
- The Mega Hydrate Powder label’s directions of use suggest the consumer take “two (2) 1/8 tsp scoops daily and gradually increase to four (4) scoops daily,” but the serving size lists 500 mg. The serving size listed should be 1/2 tsp (4 scoops); this amount must be followed by the equivalent metric quantity in parenthesis.
- The Mega Hydrate Capsule label’s directions of use suggest the consumer take “two (2) capsules daily, and gradually increase to four (4) capsules daily,” but the serving size lists 2 capsules. The serving size listed should be 4 capsules.
4. Your Crystal Energy, Mega Hydrate Powder, and Mega Hydrate Capsule 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 of your products does not comply with 21 CFR 101.36. For example:
- Your Crystal Energy product label declares a proprietary blend containing the (b)(2)-dietary ingredients potassium and magnesium and your Mega Hydrate Powder and Mega Hydrate Capsule products declare a proprietary blend containing the (b)(2)-dietary ingredient potassium. Any (b)(2)-dietary ingredients must be declared in accordance with 21 CFR 101.36(b)(2), but if they are present in amounts that can be declared as zero in 101.9(c), they cannot be declared in the Supplement Facts label.
- Your Mega Hydrate Capsule product label lists the “Other ingredients” in the (b)(3)-dietary ingredient section within the Supplement Facts label. The “Ingredients” or “Other Ingredients” must be listed outside and immediately following the Supplement Facts label as required by 21 CFR 101.4(g).
5. Your Crystal Energy 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 fails to identify the product by using the term “dietary supplement” as a part of the product’s statement of identity, as required by 21 CFR 101.3(g).
The violations cited in this letter are not intended to be an 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 your firm complies with all requirements of federal law, including the Act and its implementing regulations.
You should take prompt action to correct the violations cited in this letter. Failure to do so may result in legal action without further notice, including, without limitation, seizure and/or injunction.
We offer the following comments:
1. Your firm includes ‘best by date’ for the dietary supplement products including, Mega Hydrate Powder, Mega Hydrate Capsules, and Crystal Energy. During the inspection, you informed our investigator that you did not conduct or have any data supporting the expiration dates listed on the product labels. Any expiration date you place on a product label should be supported by data that demonstrates the product’s shelf life [See 72 Fed. Reg. 34752, 34856 (Jun. 25, 2007)].
2. Your Mega Hydrate Powder and Mega Hydrate Capsule product labels bear the following statement: “%DV based on 2000 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).
3. Your Mega Hydrate Powder and Mega Hydrate Capsule product labels list “Oliec acid” as a dietary ingredient. If your intent was to list oleic acid, the word is misspelled.
Please respond in writing within fifteen (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 corrective actions within fifteen (15) 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 non-compliance 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: Kathleen S. Tormey, Compliance Officer; P.O. Box 25087, Denver, Colorado, 80225-0087. You may reach Ms. Tormey at (303) 236-3137 or via email at Kathleen.email@example.com if you have any questions about this matter.
LaTonya M. Mitchell
Program Division Director
Office of Human and Animal Foods –
Division IV West
Executive Secretary/Office Manager
271 S. Airpark Rd.
Cottonwood, AZ 86326
This page was posted on March 26, 2019.