Inspections, Compliance, Enforcement, and Criminal Investigations
Lumina Health Products, Inc. 8/1/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, Florida 32751
w/ DELIVERY CONFIRMATION
August 1, 2013
Mr. Mark Rubin, President
Lumina Health Products, Inc.
2301 Porter Lake Drive
Sarasota, Florida 34240
Dear Mr. Rubin,
The Food and Drug Administration (FDA) conducted an inspection of your dietary supplement facility located in Sarasota, Florida, at the above referenced address, from November 26, - November 30, 2012. The inspection found significant violations of FDA’s Current Good Manufacturing Practice (CGMP) in the Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulation, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). At the conclusion of the inspection, you were issued a Form FDA 483 (FDA 483), Inspectional Observations, which listed a number of the violations that cause your dietary supplement products to be adulterated within the meaning of Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] because they have been prepared, packed, or held under conditions that do not meet the CGMP requirements for dietary supplements.
Additionally, our investigator collected and reviewed labeling of your dietary supplements. The container labels for your products bear your internet website address “www.luminahealth.com” and we reviewed the labeling on your website at www.luminahealth.com in February and April of 2013. Based on our review, we have concluded that your products identified below are in violation of sections 403, 505(a), and/or 502(f)(1) of the Act [21 U.S.C. §§ 343, 355(a), and/or 352(f)(1)]. You may find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
We received a written response from you dated December 13, 2012 and February 11, 2013, concerning our investigator’s observations noted on the FDA 483 issued to you. FDA also acknowledges the receipt of your procedures and forms your firm plans to implement as corrections to the observations. We address each relevant procedure below, in relation to each of the noted violations.
UNAPPROVED NEW DRUGS
Your promotional materials and the labeling on your website www.luminahealth.com, were reviewed in February and April of 2013, and we have determined that your products CELLFOOD, CELLFOOD Natural Weight Loss Formula, CELLFOOD SAM-e Liquid Formula, and CELLFOOD Essential Silica Formula are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The disease claims on your website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
Examples of some of the claims observed on your promotional materials that provide evidence that your products are intended for use as drugs include:
CELLFOOD SAM-e Liquid Formula brochure:
- “The antidepressant effects of SAM-e have been documented in many studies. SAM-e is prescribed in by many psychiatrists to treat depression, particularly for those who haven’t responded to other drugs, or who are reluctant to take prescription antidepressants because of side effects.”
- “Studies have shown that it relives osteoarthritic pain and some fibromyalgia symptoms and can make a significant difference in fighting depression.”
- “[R]esearchers found SAM-e as effective as pharmaceutical treatments for pain and inflammation…”
CELLFOOD and FIBROMYALGIA Promotional Flyer:
- “Tender points on body, a painful and common symptom of FMS [fibromyalgia syndrome], were noticeably reduced by the use of CELLFOOD”
- “[N]utritional Supplement Effective for Symptoms of Fibromyalgia”
- “[S]uffers are likely to experience reductions in pain and fatigue when they take recommended dosages of CELLFOOD…”
- “30 patients who did not respond to conventional therapies for fibromyalgia syndrome (FMS) found that both subjective and objective levels of pain…were significantly improved…”
- “The researchers reported that after 12 weeks of treatment with CELLFOOD, there was a marked clinical improvement of Fibromyalgia’s symptomatology...”
CELLFOOD AND ASTHMA Promotional Flyer:
- “All twenty participants were long-time asthma suffers, and took Cellfood for three months.”
- “Most participants reported that Cellfood enabled them to use inhalers less frequently”
- “Reference: ‘Cellfood Concentrate and patients with asthma,’ By Alan O’Toole, Secretary Friends of Asthma, and Dr. Jackie Paul.”
Examples of some claims observed on your website www.luminahealth.com that provide evidence that your products are intended for use as drugs are identified below. Some of these claims include 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.
Testimonials and Product Links:
- “It’s been said that all forms of illness can be traced to two basic causes: too many toxins in the body…Cellfood is the only product that addresses these…”
- “Pain from my inflamed joints gets pretty severe, but I dislike taking pain-killers that make me feel drowsy and knocked out all day. I’ve always preferred natural remedies whenever possible. Your Cellfood Silica product is a wonderful find! It helps me function without pharmaceutical medications. When my pain is the worst I double the Cellfood Silica dosage – and it works!”
- “Cellfood Natural Weight Loss Formula…improving the cardiovascular system by maintaining…LDL cholesterol (damaging cholesterol)…keeping arteries clear…”
- “Relatively new to the American market, SAM-e has been available by prescription in Europe for many years as a therapy for anti-depression, chronic fatigue syndrome and fibromyalgia.”
- “Joint Support and Osteoarthritis…[i]n clinical trials with over 22,000 patients, researchers found SAM-e as effective as pharmaceutical treatments for pain and inflammation...”
- “There have been a number of studies on the use of SAM-e for depression.
CELLFOOD SAM-e Liquid Formula:
- “[P]atients, researchers found SAM-e as effective as pharmaceutical treatments for pain and inflammation…”
- “[S]tudies on the use of SAM-e for depression.”
- “SAM-e is an approved treatment for osteoarthritis by the American Arthritis Association.”
- “Studies on SAM-e suggest it can help normalize liver enzyme levels and liver function in patients with cirrhosis, hepatitis and cholestasis. And SAM-e has been found to prevent or reverse liver damage caused by certain drugs.”
On your home page and under “Articles about CELLFOOD,” you provide the following link under “Oh My Aching Body! [w]ith the following claim:
- “[P]roven regimen for healing from the effects of fibromyalgia.”
On your left side of your home page under “Frequently Asked Questions,” you provide the following link to the following book, “CELLFOOD Vital Cellular Nutrition for the New Millennium” with the following claims:
- “Until recently, I was a severe asthmatic who was also suffering from emphysema and chronic bronchitis…I was introduced to Cellfood and started taking it right away…[t]o this day, I have not been short of breath and am still taking Cellfood.”
- “I hate having asthma, and hate asthma medication. Since taking Cellfood, for the first time in my entire life I know what it feels like to take a deep, complete, satisfying lung full of air. Breathing is so much easier, and I can actually emerge from an attack much faster and easier.”
- “I want to share my experience with Cellfood after taking it 3 times daily for one month. I feel less stressed and more calm and relaxed— but most important to me is the effect on my blood pressure, which had been 150/90. Now my blood pressure fluctuates between 132/70 and 122/70…”
Your CELLFOOD, CELLFOOD Natural Weight Loss Formula, CELLFOOD SAM-e Liquid Formula, and CELLFOOD Essential Silica Formula are not generally recognized as safe and effective for the above referenced uses and therefore, the product is a “new drug” under Section 201(p)(1) of the Act [21 U.S.C. § 321(p)(1)]. A new drug may not be legally marketed in the United States without prior approval from FDA as described in Section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
Furthermore, these products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Therefore, adequate directions cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, these drugs are misbranded within the meaning of Section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that their labeling fails to bear adequate directions for use. The introduction of a misbranded drug into interstate commerce is a violation of Section 301(a) of the Act [21 U.S.C. § 331(a)].
DIETARY SUPPLEMENT CGMP VIOLATIONS
Even if the products listed above did not have disease claims which make them drugs, these dietary supplement products, in addition to CELLFOOD MultiVitamin and CELLFOOD DNA*RNA Cell regeneration Formula are adulterated based on the following significant violations:
- Your firm failed to make and keep written procedures for the responsibility of quality control operations, including written procedures for conducting a material review and making a disposition decision, as required by 21 CFR 111.103 and 21 CFR 111.140(b)(1). Your firm's quality control personnel must approve for release, or reject, any packaged and labeled dietary supplement (including a repackaged or relabeled dietary supplement) for distribution, as required by 21 CFR 111.127(h). You provided no written procedures for the approval for release of your dietary supplements by the quality control personnel.
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)). In addition, you must establish and follow written procedures for the responsibilities of the quality control operations (21 CFR 111.103). However, you provided no written procedures for, or documentation of, the approval for release of your dietary supplements by the quality control personnel.
We have reviewed your responses dated December 13, 2012 and February 11, 2013. You provided various quality control procedures, including a Standard Operation Procedure (SOP) for Product Distribution. However, your response is inadequate. This SOP does not address the firm’s quality control personnel responsibility as the distributor of these dietary supplements. Your SOP provides no written procedures for the approval and release of your dietary supplements by the quality control personnel.
You also indicated to our investigators during the inspection that you will discontinue your labeling operation. However, you did not indicate when you will cease your labeling operation and what you intend to do with the 11,000 unlabeled bottles of CELLFOOD with Dissolved Oxygen, Trace Minerals, Plant Source Amino Acids and Enzymes (1 FL OZ).
We note that, to the extent you receive products from a supplier for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier), you must establish specifications to provide sufficient assurance that the product you receive is adequately identified and is consistent with your purchase order, as required by 21 CFR 111.70(f). However, your firm did not establish specifications for the product CELLFOOD with Dissolved Oxygen, Trace Minerals, Plant Source Amino Acids and Enzymes (1 FL OZ) you received from the manufacturer, Nu Science Corporation, to the extent they are a supplier, as required by 21 CFR 111.70(f).
Moreover, to the extent that Nu Science 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)). 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).
- Your firm failed to make and keep written procedures for returned dietary supplements, as required by 21 CFR 111.503 and 21 CFR 111.535(b)(1). Specifically, you did not have written procedures for handling any returned dietary supplement, including when a returned dietary supplement may be salvaged in accordance with 21 CFR 111.520, or when a dietary supplement must be destroyed or otherwise suitably disposed of in accordance with 21 CFR 111.515.
We have reviewed your response letters, dated December 13, 2013 and February 11, 2013, and have determined your response to be inadequate. You state in your response letter dated December 13, 2012 that you “have created an SOP and log pertinent to keeping written procedures for returned dietary supplement.” The SOP did not provide a procedure for material review and disposition decision whether to salvage or destroy a product. Therefore, your response is inadequate.
- You failed to establish and follow written procedures for packaging and labeling operations, as required by 21 CFR 111.403 and 21 CFR 111.430(b). Specifically, you indicated to our investigator, at the time of inspection, that you have approximately 11,000 bottles of Cellfood® that was unlabeled and were not able to identify any written procedure for handling this unlabeled product.
We have reviewed your responses dated December 13, 2012 and February 11, 2013. Your response did not address whether you would continue to label the approximately 11,000 bottles of Cellfood® that was unlabeled and the final disposition of these unlabeled products.
- Your firm failed to establish written procedures to fulfill the requirements related to product complaints as required by 21 CFR 111.553, and for the review and investigation of product complaints, as required by 21 CFR 111.560. Specifically, your product complaint procedures did not specify that a qualified person review and investigate any product compliant that involves a possible failure of a dietary supplement to meet any of its specification, or any other requirement of 21 CFR Part 111 (see 21 CFR 111.560(a)), a quality control personnel must review and approve decisions about whether to investigate a product complaint and review and approve the findings and followup action of any investigation performed (see 21 CFR 111.560(b), and specify that the review and investigation of the product complaint must extend to all relevant batches and records (see 21 CFR 111.560(c))
We have reviewed your response dated December 13, 2012. Your response provided an SOP and log pertinent to product complaints. However, we have reviewed the SOP and log and found them to be inadequate to meet the requirements under 21 CFR 111.553 and 21 CFR 111.560.
- Your firm did not establish written procedures for holding and distributing operations, as required by 21 CFR 111.453.
We have reviewed your response dated December 13, 2012. In your response, you provided a copy of a written procedure entitled "Product Receipt, Warehousing and Distribution." However, the response is inadequate in that the document did not address the following:
- Holding the product under conditions that do not lead to the mixup, contamination or deterioration of product (21 CFR 111.455(c));
- Holding the reserve samples under conditions consistent with product labels or, if no storage conditions are recommended on the label, under ordinary storage conditions (21 CFR 111.465(a)(1));
- Retaining reserve samples for 1 year past the shelf life date (if shelf life dating is used), or for 2 years from the date of distribution of the last batch of dietary supplement associated with the reserve sample (21 CFR 111.465(b)).
You also remarked in your response that “neither humidity nor lighting – in all forms – have any effect on the composition or efficacy of the products, and are therefore not measured” and identified the “prescribed range of temperature [of holding products] between (b)(4) and (b)(4)F. Please provide a basis on why humidity and lighting do not affect the composition or efficacy of the products and why the basis of the temperature range is acceptable and do not affect product quality.
MISBRANDED DIETARY SUPPLEMENTS
Your CELLFOOD® (1 fl. oz. ), CELLFOOD® DNA•RNA (1 fl. oz.), CELLFOOD® SAM-e LIQUID FORMULA+ (1 fl. Oz.) , CELLFOOD® MultiVitamin (1 fl. oz.), CELLFOOD® NATURAL WEIGHT LOSS FORMULA (4 fl. oz.) and CELLFOOD® ESSENTIAL SILICA FORMULA (4 fl. oz.) dietary supplement 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 labels failed to comply with 21 CFR 101.36 as follows:
- The dietary ingredients in your Cellfood®, CELLFOOD® DNA•RNA, and CELLFOOD® MultiVitamin proprietary blends are not indented under the term “Proprietary Blend as required by 21 CFR 101.36(c)(2);
- You list the dietary ingredients “plant source amino acid blend” and “ plant source enzyme blend” on your CELLFOOD® and CELLFOOD® MultiVitamin product labels, but you failed to list the individual trace minerals, amino acids, and enzymes within the “Supplement Facts” panels, as required by 21 CFR 101.36(b)(2) and (b)(3);
- The products label for CELLFOOD® and CELLFOOD® MultVitamin list ingredients such as "Purified Water" and "Dissolved Oxygen" inside the Supplement Facts panel. Under 21 CFR 101.4(g), these ingredients must be listed immediately below the nutrition label, or, if there is insufficient space below the nutrition label, immediately contiguous and to the right of the nutrition label. These ingredients must be preceded by the word "Ingredients," unless some ingredients (i.e., sources) are identified within the nutrition label in accordance with 21 CFR 101.36(d);
- You failed to declare the individual dietary ingredients in your Cellfood® Proprietary Blend on the product label of your CELLFOOD®, CELLFOOD® MultiVitamin, CELLFOOD® DNA•RNA Cell Regeneration Formula, CELLFOOD® SAM-e Liquid Formula+, CELLFOOD® NATURAL WEIGHT LOSS FORMULA, and CELLFOOD® ESSENTIAL SILICA FORMULA as required by 21 CFR 101.36(c);
- Nutrition information is not enclosed in a box using hairlines as required by 21 CFR 101.36(e)(1) and (e)(2), respectively;
- Each of the dietary ingredients listed on the label above and beneath it are not separated by a hairline rule centered between the lines of text, as required by 21 CFR 101.36(e)(5);
- The labels do not include any of the bars required by 32 CFR 101.36(e)(6)-(7) to separate sections of the Supplement Facts panel.
The violations cited in this letter are not meant to be an all-inclusive list of violations in your products and their labeling. It is your responsibility to ensure that your products are in compliance with the Act and its implementing regulations. We advise you to review your website, products labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act. You should take prompt action to correct the violations cited in this letter and prevent their recurrence. Failure to do so may result in enforcement action by FDA without further notice, including seizure and/or injunction.
In addition to the above violations, we have the following comments:
- You stated to our investigator that your firm maintains an incoming product log that documents the name of the product, lot number, date the firm started shipping products for distribution and the product expiration date. Please note any expiration date you place on a product should be supported by data that demonstrates the product’s shelf life [See 72 Fed. Reg. 34752, 34856 (Jun. 25, 2007).
- You also stated to our investigator that, based on the “law of naturally occurring elements, you may list what you believe to be “naturally occurring substances present in all living things” on the label without testing [analytically] for their presence in the product. There is no exemption from identity testing in 21 CFR Part 111 for “naturally occurring substances present in all living things.” You are required to verify that all the dietary ingredients listed on your label are scientifically identified and assayed.
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 costs related to re-inspection. A re-inspection 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. 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 costs related to re-inspection.
Within fifteen (15) working days from your receipt of this letter, please notify this office in writing of the specific steps you have taken to correct all of the violations described above. Include in your response documentation to show that correction has been achieved. Additionally, if another firm manufactures these products, identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive these products is not the manufacturer, please include the name of your supplier, in addition to the manufacturer. If you cannot complete all corrections within 15 working days, please state the reason for the delay and the date by which you will complete the corrections.
Please send your written reply to Erica M. Katherine, Compliance Officer at the address noted above. If you have any questions with regard to this letter, Ms. Katherine can be reached at 407-475-4731 or Erica.Katherine@fda.hhs.gov.
Emma R. Singleton
Director, Florida District