FDA Warning Letter to Mayor Laboratories Inc 12/9/13

April 24, 2014
   

Department of Health and Human Services logoDepartment of Health and Human Services

 Public Health Service
Food and Drug Administration
 
Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506
Telephone: 949-608-2900 

 

WARNING LETTER
 
 
VIA OVERNIGHT MAIL
SIGNATURE REQUIRED
 
December 9, 2013                                                                                               
WL # 06-14
 
Mr. William M. Deihl, Vice President
Mayor Laboratories, Inc.
2401 S. 24th St.
Phoenix, AZ 85034
 
Dear Mr. Deihl:
 
On May 16, 2012 through May 24, 2012, an investigator with the U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility located at 2401 S. 24th St., Phoenix, AZ.  The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111.  These violations cause your dietary supplements 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)] in that the dietary supplements have been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations.  Our investigator’s observations were noted on Form FDA 483, Inspectional Observations, which was issued to you on May 24, 2012. 
 
In addition, FDA reviewed the labeling of your products, including your website at www.vitamist.com
, and found that your Slender-Mist snack spray products (“Slender-Mist sprays”) and your PuretĂ© powder product are misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343] and its implementing regulations in 21 CFR Part 101. Although our review of your labeling found that your Vitamist Spray Vitamins (“Vitamist sprays”), YES.2 Performance Enhancer, Super Cal-Pro powder, and eSbelty/B-Slim powder
[1]
are in fact unapproved new drugs, as explained further below, we also concluded that these products would be misbranded under section 403 of the Act and 21 CFR Part 101 even if they were dietary supplements. You can find the Act and FDA regulations through links on FDA’s home page at http://
www.fda.gov
.
 
We evaluated your compliance with the CGMP and food labeling regulations for dietary supplements based on your representation during the inspection that all of the products manufactured at your firm are dietary supplements, and also because the great majority of the product labels that we collected during the inspection identify or refer to the products as dietary supplements and/or bear a Supplement Facts panel.
[2]
 However, dietary supplements must be intended for ingestion. See section 201(ff)(2) of the Act [21 U.S.C. §§ 321(ff)(2)]. In other words, to be a dietary supplement, a product must be intended to be taken into the digestive tract by swallowing. Although the directions on the labels of your Vitamist sprays and YES.2 Performance Enhancer are consistent with that requirement in that they instruct the consumer to spray the product directly into the mouth, which triggers a swallowing reflex that causes it to be ingested, your website repeatedly claims that the products are absorbed through the mucous membranes inside the mouth. The website refers to this route of administration as “oral absorption” and claims that it is a more effective method of delivering nutrients than ingestion:
 
“Oral Absorption has been used in medicine for decades. With modern technology, a highly developed microliter pump can deliver powerful nutritive sprays directly to the highly absorptive inner lining of your mouth. For the first time, natural nutrients are delivered into the blood stream bypassing the G.I. tract . . . . A nutrient spray is fast, effective and safe.”
 
To the extent that your products are intended for a delivery method other than ingestion, as evidenced by the quoted statements and other similar statements on your website, the products are not dietary supplements and may not be marketed as such.    
 
 
Unapproved New Drugs
 
We reviewed your Internet website at www.vitamist.com 
in February 2013 and determined that you take orders for your products there.  Based on our review of that website and other labeling, we have determined that your Vitamist sprays, Yes.2 Performance Enhancer, eSbelty/B-Slim powder, and Super Cal-Pro powder are promoted for uses that cause the products to be drugs under section 201(g)(1)(B) of the Act. The therapeutic claims on your website and in other labeling establish that these products are intended for use in the cure, mitigation, treatment, or prevention of disease in humans. 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 that provide evidence that your Vitamist sprays are intended for use as drugs are quoted below. Unless otherwise noted, claims are from your website.
 
  • “[S]ome recent studies have looked at whether high homocysteine levels could play a part in the pathophysiology of Crohn’s and Ulcerative Colitis. The conclusion drawn from these studies is that homocysteine is found at high levels in the colonic mucosa of Crohn’s and Ulcerative Colitis patients, and can lead to a chronic inflammatory state in the colonic mucosa. 
 [W]e have a formulation with Vitamin B12, Vitamin B6, and Folic Acid, called Folicin [sic]. These nutrients have been shown to lower homocysteine levels 
.”
 
  • “In order to help reduce the levels of inflammatory cytokines … that are elevated in Crohn’s and Colitis patients, we have created a supplement to be sprayed into the mouth, called Herbal Re-Leaf [which] combines Extracts of Cayenne (fruit); Cramp Bark (bark); Echinacea Purpurea (leaf); Feverfew (leaf); Ginkgo (leaf); Hops (flower); Kava Kava (root); Wild Lettuce (leaf); Magnolia Bark (bark); Passionflower (whole plant); Rose Hips (fruit); Skullcap (leaf); Valerian (root); White Willow (bark) in a patented delivery vehicle called VitaMist Spray vitamins. … In addition to reducing levels of inflammatory cytokines…”
 
  • “Celiac disease is a disorder that causes problems in your intestines when you eat gluten … Gluten is like a poison to people with celiac disease, because it damages their intestines. 
 Vitamist Spray Vitamins can help you in solving these problems.”
 
  • “Fight colds and strengthen your immune system
    Don’t feel like letting a cold run you down this year? Try VitaMist C+Zinc[.] 
Recently members of the scientific community discovered that zinc may be capable of stopping a cold already in progress by killing the rhinovirus on contact.” 
 
  • “Cardiovascular disease, the number one killer. 
  Of the one-million new heart attacks that will occur this year, over half will result in sudden death. . . . CardioMax . . . includes essential B-vitamins and vitamin D. Fight hardening arteries the natural way, with pure nutrition.” 
 
  • “VitaMist presents Ex.O, a unique proprietary blend of herbs that may help maintain clear and free sinuses and bronchial tissues.” (from Vitamist Spray Vitamins Product Catalog)
 
  • “VitaMist Ex.O is now Breathe E-Z
    ‘The spray to help your sinus problems go away’ A breath of fresh air in a spray that helps vanish allergies 
.”
 
  • “Been trying to quit smoking for a while but just can’t do it? 
  Don’t like the idea of wearing patches or constantly chewing gum? VitaMist Habit-Free[3] is your answer. Habit-Free is designed as an easy substitute for smoking, providing 
 pure vitamins, nutrients and herbs that 
 cleanse your system and reduce cravings.” 

 

  • “Studies show that by the time we reach 60, one in 12 of us will be blind or partially sighted, rising to one in six by the time we hit 75. VitaSight is the ideal molecular oral spray vitamin supplement which could be effective in preserving eye health in those susceptible to age related changes such as Age-related Macular Degeneration (AMD).”  (from Vitamist Spray Vitamins Product Catalog)
 
  • “Cases of swine flu A (H1N1) virus infection have now been identified in at least 6 States in the United States. 
 [T]here are some basic measures that we feel everyone should take. First, we have put the [Flu] Precaution Pack together, our Vitamist FPP. This is a selection of four VitaMist Spray Vitamins that may help boost your immune reserves. If you have a strong and healthy immune system, your chances of effectively fighting attack by the swine flu may be significantly improved.”
 
  • “VitaMist Folacin – A Product for Everyone. â€Š Not a month goes by without some report appearing on the benefits of folic acid. 
 Many of these articles have associated folic acid with a reduced risk of colon cancer and cardiovascular disease, and, in combination with vitamin B12, folic acid may have a connection to Alzheimer’s disease.” (from Vitamist Spray Vitamins Product Catalog)
 
  • “Folacin: with folic acid, vitamin B6 and vitamin B12. Medical research has demonstrated that these three vitamins can reduce blood levels of homocysteine, an indicator of coronary artery disease.” (from the Mayor Laboratories product information page in the Physicians’ Desk Reference; according to information you provided to our investigator during the inspection, the Physicians’ Desk Reference product information page is one of the promotional materials used by your sales staff) 
 
  • “Product info [for Vitamist Sleep supplement spray]:

o   Natural alternative to prescription sleep aids …” 

 
In addition, your website www.vitamist.com
lists the “Top Three Vitamin Therapies for Autism” as Vitamin C, Vitamin B6 and Magnesium, and Vitamin A and includes the following statements providing evidence that your products containing these vitamins are intended for treatment of autism: 

  • Under the “Vitamin C” heading, you state that “Countless children with autism are vitamin C deficient. Many people therefore are opting to give their children a vitamin C supplement . . . . Vitamin C is supposed to have a calming effect on behavior. Vitamin C has supposedly a signaling effect on the brain, like a dopamine effect. . . . The Best Products to find Vitamin C in: Vitamist C+Zinc, Vitamist Super Cal-Pro.”

 

  • Under the “Vitamin B6 and Magnesium” heading, you state, “The enzymes that are used to break down vitamin B6 may not work well in children with autism. The breakdown of vitamin B6 is needed to make PLP [which] is needed to produce dopamine which is a brain chemical that is important in behaviors. If autistic children are not producing enough PLP from vitamin B6, then supplementing their diets with extra B6 may be needed to boost the production of PLP and dopamine to normal levels. . . .. Children who have autism may have significantly lower levels of magnesium than other children. Magnesium supplements may be useful in producing a calming effect on some children with ADHS and therefore may possible be just as useful on children who suffer from behavior problems and autism.” You list the following products as the “best products” to find Vitamin B6: VitaMist Super Cal-Pro, VitaMist Osteo-CalMag, Vitamist eSbelty Boost, and VitaMist D-stress.

 

  • Under the “Vitamin A” heading, you state, “People with autism may not have enough vitamin A in their diets.” You list the following products as the “best products” to find Vitamin A: VitaMist VitaSight and VitaMist Anti-Oxidant.
 
Further examples of website claims that provide evidence that your eSbelty/B-Slim powder product is intended for use as a drug include:
 
  • “Obesity has reached epidemic proportions in the United States and B-Slim can provide powerful support for your personal battle. Scientific studies have shown that the key nutrients found in B-Slim help control appetite, as well as improve levels of cholesterol â€Š.”
 
The claims listed above establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. See section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. Your 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 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 submitted by a drug sponsor to demonstrate that the drug is safe and effective.
 
Furthermore, your
Herbal Re-Leaf, CardioMax, Flu Precaution Pack (consisting of your Multiple, Echinacea + G, C + Zinc and Vitamin D products), C+Zinc, eSbelty Boost, D-stress, Super Cal-Pro, Osteo-CalMag, VitaSight and Anti-Oxidant products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these products 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)].
 
Your Vitamist sprays are also drugs to the extent that they are intended for buccal absorption (absorption through the tissues of the mouth). Your website includes claims asserting that your Vitamist sprays are absorbed through the tissues of the mouth and implying that the sprays are superior to dietary supplements that pass through the digestive system. For example, under the FAQ section of your website you answer one of the questions by asserting, “VitaMist’s vitamin and mineral products are classified as dietary food supplements and therefore there are no direct studies that pertain to the absorption of VitaMist products. It is important to remember, however, that there are reams of laboratory studies that validate rapid absorption of various ingredients, and many recent medical advances have adopted a delivery method involving absorption through the buccal mucosa 
.” On the product page for your Vitamin B12 spray, you state, “VitaMist Spray Vitamins, B12 spray bypasses the stomach and provides a more direct and convenient method of absorption.” There are many other similar statements on your website. Because dietary supplements must be intended for ingestion, a product intended for buccal absorption is not a dietary supplement and may not be marketed as such. If you wish to continue promoting your products with claims that they are absorbed through the tissues of the mouth, you must comply with the regulatory requirements for drugs. 

Dietary Supplement Violations
 
As explained above under “Unapproved New Drugs,” FDA considers your Vitamist sprays, Yes.2 Performance Enhancer, eSbelty/B-Slim powder, and Super Cal-Pro powder products to be drugs, rather than dietary supplements, because of their intended uses as evidenced on your website and in other labeling. However, because we understand from your statements during the inspection that you wish to market all of your products as dietary supplements, which would require complying with the CGMP and labeling requirements for dietary supplements, we are listing violations of these requirements for all of the Mayor Laboratories products that we evaluated, whether or not we consider them to be dietary supplements as currently labeled and marketed.
 
CGMP Violations:
 
1.   
You failed to establish specifications for any point, step, or stage in the manufacturing process where control is necessary 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 111.70(a)]. Specifically:
 
  • You failed to establish identity specifications for each component you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b)(1). Specifically, our investigator determined that you failed to establish such specifications for your Children’s Multiple product. Further, you failed to provide documentation of  specifications for other components you use for your dietary supplements products, as required by 21 CFR 111.70(b)(1).

  • You failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplements you manufacture [21 CFR 111.70(e)].
 
In addition, we note that not only must you establish specifications, as required by 21 CFR 111.70, but you must also determine whether the specifications are met [see 21 CFR 111.73].
 
2.    You did not conduct at least one appropriate test or examination before using a component to verify the identity of any component that is a dietary ingredient as required by 21 CFR 111.75(a)(1)(i). Specifically, you told our investigator that you do not conduct identity testing of raw materials.  
The requirement to verify the identity of any component that is a dietary ingredient applies unless you petition FDA under section 21 CFR 111.75(a)(1)(ii) and FDA exempts you from such testing. FDA has not received any petition from you under § 111.75(a)(1)(ii) for an exemption from the identity testing requirement.
 
3.    You failed to confirm the identity of other components (not including dietary ingredients) and determine whether other applicable component specifications established in accordance with 21 CFR 111.70(b) are met by either conducting appropriate tests or examinations, or by relying on a certificate of analysis (COA) from the supplier of the component that you receive, as required by 21 CFR 111.75(a)(2). Specifically, during the inspection it was determined that you do not conduct any testing of raw materials upon receipt. Furthermore, you failed to provide any documentation that you qualified any of your suppliers in order to rely on the certificates of analysis (COA’s). 
 
In accordance with 21 CFR 111.75(a)(2)(ii), in order to rely on a certificate of analysis from the supplier of the component that you receive, (A) You first must qualify the supplier by establishing the reliability of the supplier’s certificate of analysis through confirmation of the results of the supplier’s tests or examinations; (B) The certificate of analysis must include a description of the test or examination method(s) used, limits of the test or examinations, and actual results of the tests or examinations; (C) You must maintain documentation of how you qualified the supplier; (D) You must periodically re-confirm the supplier’s certificate of analysis; and (E) Your quality control personnel must review and approve the documentation setting forth the basis for qualification (and re-qualification) of any supplier.
 
4.    You failed to identify, in your master manufacturing records (MMRs), specifications for the points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of your dietary supplements, as required by 21 CFR 111.205(b)(1). 
Specifically, our investigator observed that your MMRs for your Vitamist Spray Vitamins Children’s Multiple, Melatonin, Prenatal, Yes.2 Performance Enhancer, VitaSight, D-Stress, Smoke-Less,
[4]
Lady Mate, St. John’s Wort, Multiple and Folacin products. The MMRs for these products were composed solely of the ingredients and quantities needed to produce each batch of dietary supplements.
 
5.    You failed to establish written procedures for manufacturing operations, as required by 21 CFR 111.353. Specifically, you informed our investigator that you have only established written procedures for cleaning and sanitation. The requirements for manufacturing operations are specified in 21 CFR 111.355, 111.360, 111.365, 111.370 and 111.375. 
 
Misbranding Violations
:
 
1.    The Vitamist sprays, Slender-Mist sprays, YES.2 Performance Enhancer, and the Super Cal-Pro, PuretĂ©, and eSbelty/B-Slim powders are misbranded within the meaning of Section 403(q)(5)(F) of the Act in that the presentation of nutrition information on the labeling for these products does not comply with 21 CFR 101.36. For example:
 
  • The YES.2 Performance Enhancer, the Tropical Delite and Berry Supreme Slender-Mist sprays, the eSbelty/B-Slim, PuretĂ©, and Super Cal-Pro powders, and the eSbelty Boost, Osteo-CalMag, Ex.O, and Minerals Vitamist sprays fail to bear a Supplement Facts panel as required by 21 CFR 101.36(e).

 

  • The Vitamist Grape Seed, Vitamist Pine Bark and Vitamist C+Zinc product 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).

 

2.    The YES.2 Performance Enhancer, the eSbelty/B-Slim, PuretĂ©, and Super Cal Pro powder, and the Chocolate Fudge, Tropical Delite, ArcticMint, and Berry Supreme Slender-Mist sprays are misbranded within the meaning of section 403(s)(2)(B) of the Act in that the label fails to identify the product as a 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 that the word “dietary” may be deleted and replaced by the name of the dietary ingredient in the product or by a descriptive term indicating the type of dietary ingredients that are in the product (e.g., “herbal supplement with vitamins”).   
 
3.    The YES.2 Performance Enhancer, PuretĂ© powder, and the Tropical Delite, Arctic Mist, and Berry Supreme Slender-Mist sprays are misbranded within the meaning of Section 403(y) of the Act in that the label fails to include a complete domestic address or domestic phone number through which the responsible person (as described in section 761(b) of the Act) may receive a report of a serious adverse event with such dietary supplement. 
 
The violations cited in this letter are not intended to be an all-inclusive statement 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 assure that your firm complies with all requirements of federal law and FDA regulations. 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/or injunction.
 
In addition to the above violations, we have the following comments:
 
  • During the inspection, you informed our investigator that you do not provide CGMP training to your employees. We note that each person engaged in manufacturing, packaging, labeling, or holding dietary supplements, or in performing any quality control operations, must have the education, training, or experience to perform the person’s assigned functions [21 CFR 111.12(c)].

 

  • We suggest that you have data to support any “expiration date” you apply to your firm’s finished dietary supplement products (see 72 FR 34752 at 34856; June 25, 2007).

 

  • We also note that your Pre-Natal spray, Melatonin spray, Children’s Multiple spray, C+Zinc spray and other Vitamist sprays are labeled as containing stevia, which is declared under “other ingredients.” Whole-leaf and crude stevia extracts are not approved for food use as a sweetener. Certain highly purified steviol glycosides obtained from stevia leaves have been the subject of generally recognized as safe (GRAS) notices. FDA has not objected to the use of these highly refined substances as sweeteners, which are generally referred to as Rebaudioside A (see FDA’s GRAS notice inventory: http://www.accessdata.fda.gov/scripts/fcn/fcnNavigation.cfm?rpt=grasListing).
 
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.
 
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 noncompliance 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 noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
 
If you have any questions regarding this letter, please contact Dr. Raymond W. Brullo, Compliance Officer, at (949) 608-2918.
 
Your written reply should be sent to:
 
Blake Bevill
Director, Compliance Branch
US Food & Drug Administration
19701 Fairchild
Irvine, CA 92612-2446
 
 
Sincerely,
/S/ 
Alonza E. Cruse
Director
Los Angeles District
 
 
 
Cc:
Hugo Cornejo, Acting Branch Chief, Food and Drug Branch
California Department of Public Health
1500 Capitol Ave.
~
MS 7602
P.O. Box 997413
Sacramento, CA 95899-7413

[1]
The product in question is a weight loss product in powder form. The product label pictured on your website identifies the product as “eSbelty,” as does the product label we collected during our inspection, but your website sometimes refers to the same product as “B-Slim.” Accordingly, this letter uses both product names except when quoting from the website. 

[2]
The exceptions are the YES.2 Performance Enhancer and the Tropical Delite and Berry Supreme Slender-Mist sprays, whose labeling did not include the term “dietary supplement” or bear a Supplement Facts panel.

[3]
“Habit-Free” is the name currently used on your website for the product whose label bears the name “Smoke-Less.” 

[4]
The “Smoke-Less” product is now referred to as “Habit-Free” on your website, although the pictured label still identifies the product as “Smoke-Less.” 

This page was posted on April 24, 2014.