Source: https://www.fda.gov/iceci/enforcementactions/warningletters/2016/ucm521441
Timestamp: 2018-12-15 11:05:42
Document Index: 508920011

Matched Legal Cases: ['§ 321', '§331', '§ 352', '§ 201', '§ 353', '§ 352', '§ 331', 'art 111', '§ 343', '§ 343', '§ 343', '§ 343', '§ 379', '§ 379']

Positive Power Nutrition 9/15/16
WL # 46-16
Mr. Burt D. Goulding Jr., President
26346 Madison Ave.
Dear Mr. Goulding:
From February 2 to March 4, 2016, the U.S. Food and Drug Administration (FDA or we) inspected your facility located at 26346 Madison Ave., Murrieta, California. Based on our inspection and subsequent review of your product labeling collected during the inspection, we found significant 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 the FDA's home page at www.fda.gov.
We acknowledge your response letter, dated and received March 18, 2016 in the Los Angeles District Office, to the Form FDA 483, Inspectional Observations, issued to you at the conclusion of the inspection on March 4, 2016, and we address your response below.
New Drugs/Misbranded Drugs
FDA has reviewed labeling for your products High Energy C-Complex, Positive Vitality, Positive Performance, Positive CardioGuard, B-Complex 100, Positive Essentials, Positive Energy Boosters, Omega-3 Marine Lipid Oil, B-12 Booster Shot, Cell Power, and Super Silica obtained during our inspection of your facility. The claims on these materials 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.
From product labels:
High Energy C-Complex -
• "[H]elps the body heal from ... varicose veins ...
B-Complex 100 -
• "[P]rotects against cardiovascular disease ... helps reduce blood cholesterol... "
Positive Essentials-
• "[F]rom combating infection to repairing tissue ... They are also essential in treating and preventing a multitude of diseases ... "
• "They also help prevent ... varicose veins ...
• "[H]ave been found to aid in the healing of gastritis, liver disorders, asthma, anemia ... "
Positive Energy Boosters -
• "It reduces blood cholesterol ... used to treat dizziness and ringing in the ears, helps prevent depression, mental illness and migraine headaches ... "
• "[H]elps in the formation of red blood cells, thus helping prevent anemia ... "
• "[S]upports the thyroid to counteract depression ... "
• "[P]romotes normal blood pressure ... It prevents muscle aches ... headaches, ulcers, and sore throats ... "
Positive Vitality-
Positive Performance -
Positive CarioGuard -
Super Silica -
• "Declining levels of silica are related to brittle bones, stiff joints ... "
Omega 3 Marine Lipid Oil -
• "[H]elps thin blood that is too thick or sticky ... EPA has been clinically proven to improve the health of those with heart disease, asthma, and cholesterol. It also helps with migraines and depression ... "
B-12 Booster Shot -
• "Deficiency can cause bone loss, chronic fatigue, depression, constipation, ... ringing in the ears, and pernicious anemia ... "
From brochures, flyers, etc.
Cell Power and Super Silica [-
• "HEALTH CONDITIONS THAT ARE COMPATIBLE WITH ... Allergies ... Arthritis / Joint Pain ... Atherosclerosis / High Blood Pressure ... Bacterial / Vital Infections ... Brain Disorders (bipolar, ADD, memory loss, etc.) ... Candida / Fungal Infections ... Chronic Fatigue Syndrome ... Diabetes (Type I and Type II) ... Fibromyalgia ... GI Tract Disorders ... Heavy Metal Toxicity ... High Blood Pressure (pH related) ... Indigestion / Acid Reflux ... Kidney I Bladder Infections ... Kidney Malfunctions ... Osteoporosis ... COPD, asthma ... Varicose Veins I Spider Veins ... "
• "Rapidly Declining Silica Levels Damage Health ... improve conditions such as psoriasis and eczema from the inside out ... Brittle Bones ... Cavities ... Chronic Bursitis, Arthritis ... Spider Veins, Varicose Veins ... support of the spider-vein healing ... healing of varicose veins ... High Blood Pressure ... Bipolar ... Neuropathy, Autism ... Aluminum accumulation may be a major cause of Alzheimer's, ADD, ADHD, autism, and bipolar disorders. Other serious toxins are related to MS and neuropathy. Silica helps the body eliminate toxins, including metals. The more silica, the less aluminum and other heavy metals ... Irregular Heartbeats (Arythmia (sic), Tachycardia) ... Lack of silica in the SA node may cause irregular heartbeats ... "
• "Silica is needed for calcium management. Bones become brittle without sufficient silica."
SuperSilica-
• "Reported Benefits of Silica Supplementation ... Reduction of pain & inflammation in the joints ... She has dealt with chronic constipation her whole life ... "
• "Speed Healing ... Silica supplementation may be useful for people who have concerns similar to the following ... Bone Loss ... GI Tract Disorders ... Chronic Soreness ... Hardening of the Arteries ... Blood Pressure Imbalance ... Varicose Veins ... Heavy Metal Toxicity ... effective in regulating plaque deposits in artery walls and it is abundant (up to 14 times more) in the arteries of people who are free from heart disease ... can help with wound and bum healing ... an important therapeutic substance for many diseases ... "
CellPower-
• "I have soreness in my ankles, knees, back, and hands. I can already feel the difference in my joints. I also have chronic stomach discomfort, now my stomach doesn't hurt ... I used to suffer from allergies and my eyes swelled up ... I feel great ... don't get sick ... don't get the typical seasonal sniffles ... "
• "Cellular Oxygenation and Detoxification may be useful for people who have concerns similar to the following ... Seasonal Allergies ... Breathing Difficulties... Joint Discomfort ... Chronic Muscle Aches ... can disrupt viruses, and dissolve infectious bacteria, fungi, mold, and parasites ... which speeds the healing of respiratory difficulties ... The primary cause of cancer is the replacement of normal oxygen respiration with anaerobic respiration ... "
Your High Energy C-Complex, Positive Vitality, Positive Performance, Positive CardioGuard, B-Complex 100, Positive Essentials, Positive Energy Boosters, Omega-3 Marine Lipid Oil, B-12 Booster Shot, Cell Power, and Super Silica 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)]. 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(t)(l) of the Act [21 U.S.C. § 352(t)(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 C.F.R.§ 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 B-Complex 100, Positive Essentials, Positive Energy Boosters, Omega-3 Marine Lipid Oil, B-12 Booster Shot, Cell Power, and Super Silica products are offered for conditions that are not amenable to self-diagnosis and treatment. Therefore, it is impossible to write adequate directions for a layperson to use these 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(t)(1) of the Act [21 U.S.C. § 352(t)(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)].
Even if your products High Energy C-Complex, Positive Vitality, Positive Performance, Positive CardioGuard, B-Complex 100, Positive Essentials, Positive Energy Boosters, Omega-3 Marine Lipid Oil, B-12 Booster Shot, Cell Power, and Super Silica products were not unapproved new drugs, they would be adulterated dietary supplements based on the violations listed below. During the inspection, our investigator evaluated your dietary supplement manufacturing, packaging, labeling, and holding operations and identified significant violations of the dietary supplement Current Good Manufacturing Practice (CGMP) regulations found in 21 Code of Federal Regulations (21 CFR) Part 111. These violations cause the above listed products, as well as any other dietary supplement products you prepare, pack, or hold, to be adulterated within the meaning of 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 CGMP regulations for dietary supplements.
1. Your quality control personnel did not take appropriate steps with respect to a dietary supplement for which a specification was not met, as required by 21 CFR 111.77(a). Specifically, your records indicate that you received a certificate of analysis dated 3-19-2015 for product (b)(4), associated with your Cell Power product, (b)(4). This certificate of analysis indicated that the lot failed to meet specifications for pH; however, your quality control personnel did not reject the product or approve a treatment, in process adjustment, or reprocessing to ensure the quality of the finished dietary supplement. See also 21 CFR 111.113.
We have reviewed your response letter, received March 18, 2016. We are unable to evaluate the adequacy of your proposed corrective action because you did not provide us with documentation of your corrective action.
2. You did not implement quality control operations to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.65. Specifically, your SOP 7 states that the quality control manager is responsible for overseeing the implementation of the Contract Manufacturing Agreement and SOP 8 states that "the Agreement shall provide for Company oversight of the Manufacturer GMP compliance." However, you stated to the FDA investigator that the contract manufacturer is responsible for the GMPs and that you do not have any written Contract Manufacturing Agreements with any of your contractors.
As a distributor that contracts with other manufacturers to manufacture, package, or label dietary supplements that your firm releases for distribution under your firm's name, your firm has an obligation to know what and how these activities are performed so that you can make decisions related to whether the products conform to established specifications and whether to approve and release the products for distribution [72 Fed. Reg. 34752, 34790 (June 25, 2007)]. Your firm introduces or delivers, or causes the introduction or delivery, of dietary supplements into interstate commerce for distribution to consumers. As such, your firm has an overarching and ultimate responsibility to ensure that all phases of the production of that product are in compliance with dietary supplement CGMP requirements.
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 tum 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)).
Your firm must establish a system of production and process controls and implement quality control operations to ensure the quality of your dietary supplements and that the dietary supplements are packaged and labeled as specified in the master manufacturing record (21 CFR 111.55 and 111.65). You firm must establish and follow written procedures for the responsibilities of the quality control operations (21 CFR 111.103). The quality control personnel must ensure that your 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, you must have documentation of the quality control personnel review and approval of release for any packaged and labeled dietary supplement (21 CFR 111.127(h) and 111.140(b)(2)).
We have reviewed your response letter, received March 18, 2016. We are unable to evaluate the adequacy of your proposed corrective actions because you did not provide us with documentation of a changed procedure that includes appropriate quality control operations to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record.
Even if your products Positive Vitality, Positive Performance, Positive CardioGuard, B-Complex 100, Positive Essentials, Positive Energy Boosters, Omega-3 Marine Lipid Oil, B-12 Booster Shot, Cell Power, and Super Silica products were not unapproved new drugs, they would be misbranded dietary supplements based on the violations listed below. In addition, your Healthy Greens , Complex, Power of Minerals, Super Circulation Herbal Complex dietary supplement products are misbranded based on the following:
1. Your Cell Power, Super Silica, Positive CardioGuard, Healthy Greens Complex, Positive Essentials, Super Circulation Herbal Complex, Power of Minerals, and Positive Vitality products are misbranded within the meaning of section 403(i)(2) of the Act in that the product labels fail to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Specifically:
• The Cell Power, Super Silica, Positive Essentials, and Positive Vitality product labels fail to list what ingredients comprise the "Ionic Major and Trace Minerals, Amino Acids, Enzymes, Electrolytes, and Ionic Nutrients" identified as a part of the Cell Power Proprietary Blend or Cell Power Blend.
• The Positive Cardio product label fails to list what ingredients comprise the "aqueous film coating."
• The Healthy Greens Complex product label fails to list what ingredients comprise the "Green Cellulose Film Coat." Furthermore, the digestive nutrients listed are not the common or usual names of specific bacteria.
• The Positive Essentials product label fails to list the specific trace minerals that comprise the "colloidal trace minerals" as well as the ingredients that make up the capsule or softgel itself for several of the component products. Likewise, the Power of Minerals product also lists "colloidal trace minerals".
• The Super Circulation Herbal Complex product label lists "capsicum" which is not the standardized or common name as noted in Herbs of Commerce.
• Although the Positive Cardio Guard product label indicates an "Other Ingredients" list, the label does not specify which of the ingredients in the list correspond to each of the separate component products.
2. Your Cell Power, Super Silica, Super Circulation Herbal Complex, and Healthy Greens Complex products are misbranded within the meaning of section 403(q)(1)(A) because the serving size declared on the labels are 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.
• Your Cell Power Directions state to "take 5 to 10 drops in 12 - 20 fl. oz. or more of. .. up to 15 per dose ... " but the serving size states 5 drops.
• Your Super Silica Directions state to "take 15 drops in 16 ounces or more ... " but the serving size states 30 drops.
• Your Healthy Greens Complex Directions state to "take 1 or 2 tablets with a glass of water" but the serving size states 1 Tablet.
• Your Super Circulation Herbal Complex Directions state to "take 2 or 3 capsules daily with a glass of water" but the serving size states 2 capsules.
3. Your Super Circulation Herbal Complex, Positive Performance, and Healthy Greens Complex 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 labels fail 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).
4. Your Super Circulation Herbal Complex, Positive Vitality, Positive Essentials, Power of Minerals, B-12 Booster Shot, B-Complex 100, and Healthy Greens Complex 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. Specifically:
• While the Healthy Greens Complex Supplement Facts panel contains the statement "**Daily Value not established," none of the dietary ingredients have such values established but none of the dietary ingredients are noted with the "**" identifier. Further, the statement is shown at the top of the Supplement Facts panel rather than at the bottom as required by 21 CFR 101.36(b)(3)(iv).
• "Other ingredients" are shown inside the Supplement Facts panel and should be listed outside and immediately following the panel, as required by 21 CFR 101.4(g).
• Several product labels list (b)(2)- and (b)(3)-dietary ingredients co-mingled; examples of this are the B-Complex 100, B-12-Booster Shot, and Power of Minerals products. These labels do not segregate the 21 CFR 101.36(b)(2) and (b)(3) dietary ingredients into separate sections of the supplement facts panel as required by 21 CFR 101.36(b)(3)(i). Additionally, heavy bars are required immediately after the listing of the last dietary ingredient required to be declared pursuant to 21 CFR 101.36(b)(2) and (b)(3), respectively [21 CFR 101.36(e)(6)(ii) and (iii)].
• Furthermore, several product labels list the dietary ingredients in an order that is not in accordance with 21 CFR 101.36; examples of this are the Positive Cardio Guard, B-Complex 100, and Power of Minerals products. Vitamins and/or minerals must be declared in the order as prescribed, as required by 21 CFR 101.36(b)(2)(i)(B).
• Your Positive Vitality and Positive Essentials product labels fail to list the source ingredient for the selenium in the Mineral Complex 1000, as required by 21 CFR 101.36(d).
• Your Positive Vitality and Positive Essentials product labels are not in accordance with 21 CFR 101.9(c)(8)(vi) as it pertains to the listing of beta-carotene and Vitamin A.
5. Your Omega-3 Marine Lipid Oil and Positive Energy Boosters products are misbranded within the meaning of section 403(r)(l)(A) of the Act [21 U.S.C. § 343(r)(l)(A)] because the product labels bear a nutrient content claim, but the products do not meet the requirements to make such a claim.
• The label of your Omega-3 Marine Lipid Oil product bears the claim "Rich in 100% Natural EPA & DHA Fatty Acids." FDA has issued a regulation specifying criteria for the use of the nutrient content claim "rich" in food labeling [21 CFR 101.54(b)(1)]. This regulation requires a food that bears this claim to contain 20 percent or more of the Daily Value (DV) of the nutrient per reference amount customarily consumed (RACC). However, this regulation does not authorize your claim, "Rich in 100% Natural EPA & DHA Fatty Acids," because there are no DVs for EPA and DHA Fatty Acids.
• The label of your Positive Energy Boosters product bears the claim "LOADED with ... BEE POLLEN, GINSENG, & HERBS." Under section 403(r)(2)(A) of the Act, nutrient content claims may be made only if the characterization of the level made in the claim uses terms which are defined by regulation. However, FDA has not defined the characterization "loaded with" by regulation. Moreover, even if we determined that the term "loaded with" could be considered synonymous with the term "high" or the term "good source," both of which are defined by regulation, this claim does not comply with the requirements for use of those terms in 21 CFR 101.54(b) ("high" claims) or 21 CFR 101.54(c) ("good source" claims) because there is no established DV for bee pollen, ginseng or any herb. Likewise, your B-Complex 100 product contains the statement "double choline potency". Under section 403(r)(2)(A) of the Act, nutrient content claims may be made only if the characterization of the level made in the claim uses terms which are defined by regulation. However, FDA has not defined the characterization "double potency" by regulation. We note that manufacturers may use the specified nutrient content claims about choline that were notified to FDA based on a published authoritative statement by a scientific body under 403(r)(2)(G) on the label and in labeling of any food or dietary supplement product.1 However, your claim was not included in that notification.
6. Your Positive Performance, Positive Essentials, Positive CardioGuard, and Positive Vitality products are misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because the labels do not include a statement of identity as a "dietary supplement" as required by 21 CFR 101.3(g).
7. Your Positive Vitality product is misbranded within the meaning of section 403(u) of the Act [21 U.S.C. § 343(u)] in that it purports to contain ginseng, but the purported ginseng ingredient is not from a plant classified with the genus Panax. Section 403(u) of the Act provides that the term "ginseng" may only be considered to be a common or usual name (or part thereof) for any herb or herbal ingredient derived from a plant classified within the genus Panax. Specifically, your product contains ingredients identified as Siberian Ginseng, Brazilian Ginseng, and Wild Indian Ginseng. These ingredients may not be declared under a name that includes the term "ginseng" because they are not from the genus Panax.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.
We also have the following comments regarding the labeling of your products:
• Your principal display panel for the Super Circulation Herbal Complex product states that the product is a tablet while the Supplement Facts panel and Direction state that the product is a capsule.
• Several of your dietary supplements contain Supplement Facts panels where in the statement "Supplement Facts" does not extend the full width of the panel as required by 21 CFR 101.36(e)(1).
• The product B-Complex 100 lists the phrase "contains no yeast", which is not a required element of the Supplement Facts Panel, within the panel itself. However, 21 CFR 101.2(e) requires that information appearing on the information panel should appear without other intervening material.
• Your Positive Vitality and Positive Essentials products appear to list the source ingredient calcium carbonate with a specific amount of that ingredient. The amount of a dietary ingredient, and not the amount of the source dietary ingredient, must be listed in the nutrition information. We also note the labels indicate two other source ingredients for calcium, calcium citrate and calcium aspartate. The dietary ingredient calcium should be listed and then followed in parentheses with the names of the source ingredients for the calcium, as required by 21 CFR 101.36(d).
• For your products Positive essentials, Positive Cardio, Positive Performance and Positive Vitality you have listed as the source of several ingredient in parentheses "Nutrition 21." However, "Nutrition 21" is not the common or usual name of any source ingredient. See 101.36(d)(1).
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 reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified non-compliance 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 U.S.C. § 379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for reinspection-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 reinspection-related costs.
1500 Capitol A venue, MS-7602
1 See http://www.fda.gov/Food/IngredientsPackaginglabeling/LabelingNutrition/ucm073599.htm