Inspections, Compliance, Enforcement, and Criminal Investigations

Calwood Nutritionals, LLC. 2/2/16

  

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

Public Health Service
Food and Drug Administration
 Baltimore District Office
6000 Metro Drive, Suite 101
Baltimore, MD 21201-2199
Telephone: (410) 779-5455
FAX: (410) 779-5705

 

WARNING LETTER
CMS # 482185
 
February 2, 2016
 
Mr. Gary J. Calton, Managing Member
Calwood Nutritionals, LLC
1288 Hay Meadow Ln
Sykesville, MD 21784-5438
 
Dear Mr. Calton:
 
The United States Food and Drug Administration (FDA) conducted an inspection of your firm, Calwood Nutritionals, LLC located at 1288 Hay Meadow Ln, Sykesville, MD, on September 1, 3, & 8, 2015. During the inspection FDA collected product labels and labeling for your Amino Acid products Nutramine-Amino Bites; Nutramine; Nutrasentials Drink Mix; and DialysAid. In addition, the FDA subsequently reviewed your website at the Internet address www.calwoodnutritionals.com.  Based on our inspection and review of your product labeling, including your firm’s website, we found serious violations of the Federal Food, Drug and Cosmetic Act (the Act) and its implementing regulations.
 
You can find the Act and FDA’s regulations through links on FDA’s homepage at http://www.fda.gov.
 
Unapproved New Drug
 
The FDA reviewed your websites at the Internet addresses, calwoodnutritionals.com and shop.calwoodnutritionals.com, in November 2015. Your calwoodnutritionals.com website links directly to your shop.calwoodnutritionals.com website, where FDA has determined that you take orders for the products Nutramine-Amino Bites; Nutramine; Nutrasentials Drink Mix; and DialysAid. Additionally, the FDA has reviewed the brochures obtained during the September 2015 inspection of your facility that you include with your finished products upon shipment. The claims on your websites and brochures establish that the above-mentioned products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. 
 
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
 
From your website www.calwoodnutritionals.com:
  1. Under the “Company” tab: “Maintaining normal nutritional status is especially important in other diseases such as cancer, inborn errors of metabolism…food allergies and AIDS. Having the right building blocks available in a usable form is the best way to maintain your muscle while fighting disease. The Calwood formulas of essential amino acids provide a pleasant tasting way to obtain the nutrition you need while your doctors are fighting your disease...”
  2. Under the “Company” tab, then the “Message FROM DR. GARY CALTON, PRESIDENT” link:
“The result of this effort is the products we now have available for you so that you can delay dialysis, and you can maintain your health if you are already on dialysis…”
 
“We are convinced that many other disease states can be helped by our available products. Proper nutrition is especially important in cancer, and even for AIDS patients. We continue our research because we know that folks with food allergies, inborn errors of metabolism like phenylketonuria or gyrate atrophy also need special diets including an amino acid mixture…”
  1. Under the “Products” tab: “Nutramine-Amino BitesTM…This product is useful in:…individuals who are cachectic due to burns, cancer, muscular dystrophy or AIDS; individuals with Alzheimer’s who need additional muscle synthesis; individuals needing additional muscle synthesis…”
  2. Under the “Products” tab: “NutrasentialsTM…This product is useful in: individuals who are cachectic due to burns, cancer, muscular dystrophy or AIDS; individuals with Alzheimer’s who need additional muscle synthesis; individuals needing additional muscle synthesis…”
  3. On the homepage: “A low protein diet and a balanced formula of essential amino acids at each meal has been shown to delay the time to dialysis(1,2) and even reverse some kidney problems when treatment was started early(3). These studies also showed that the diet was as effective in people with diabetes as in those without it, a key finding as diabetes increases the risk of kidney failure significantly…”
  4. On the Diabetics page: “A number of patients with diabetes have been able to delay dialysis by going on a low protein diet with a balanced formula of essential amino acids.”
  5. On the “How to Avoid Dialysis” page: “You owe it to yourself or to the loved one in your life who has kidney disease to try this therapy…”
 “[W]as referred to Johns Hopkins one year ago with a history of hypertension for 40 years and high urinary protein for 9 years. ... He was placed on a very- low-protein diet supplemented by essential amino acids and has been checked every two months. Three years later, the lab data showed only moderate worsening ... Perhaps in response to this diet, Arnold*s nephrotic syndrome has stopped progressing although his kidney function has declined. Dialysis deferral: 3 years”
 
“[I]s a 50-year-old resource manager for the army. She was referred to us for treatment in 1995. She had been diabetic since her second pregnancy 28 years ago. ... A kidney biopsy showed focal segmental glomerulosclerosis and mild diabetic glomerulosclerosis. She had been intermittently hypertensive for years ... Lavinia was placed on a very-low-protein diet supplemented by a double dose of essential amino acids (20 g per day). Over the next few months, her kidney disease disappeared: Her serum albumin concentration rose to normal, urine protein disappeared, and GFR rose to normal. Dialysis deferral: permanent”
 
Polycystic Kidney Disease:
 
“67-year-old retired nurse with polycystic kidney disease, was found to have severe renal failure, with a glomerular filtration rate of 10.2 ml per minute and a serum creatinine concentration of 4.2 mg per dl. She was placed on a very-low-protein diet supplemented alternately by an essential amino acid mixture ... Doris managed to postpone dialysis for another year while on the same regimen, thus deferring dialysis for a total of 20 months. Clearly progression of her renal failure was very slow. —Dialysis deferral: 2 years”
 
“49-year-old school teacher, came to Johns Hopkins in 1994. Polycystic kidney disease had been diagnosed from an abdominal scan four years earlier, although it was not seen in an X ray of the kidneys at age 22. The X ray was performed because she had recurrent urinary tract infections ever since age 18 and had required urethral dilatations. High blood pressure had been present for nine years ... She had no symptoms of kidney failure. ... At her request, despite the absence of symptoms, she was placed on a very-low-protein diet supplemented by essential amino acids. ... At this rate she will be well into her 70s before she needs dialysis or transplantation. Dialysis deferral: 10 years”
 
Patients with Hypertensive Kidney Disease:
 
“[A] black retired postal supervisor, was referred at age 61 with a 20-year history of hypertension. By age 59 his serum creatinine level was elevated, though he had no symptoms of kidney disease. Physical exam showed only hypertension, but kidney function was severely reduced. He was prescribed a very-low- protein diet supplemented by essential amino acids ...During eight years of dietary treatment, kidney function did not worsen ... In retrospect, dietary treatment probably deferred dialysis for about four years.”
 
“77-year-old retired NASA engineer was referred in April 2000 with a five-year history of high blood pressure and chronic kidney failure. ... He was placed on a very-low-protein diet supplemented by essential amino acids. In the ensuing two years, his kidney function (measured every three months) has not changed. He remains essentially free of symptoms. He may never go on dialysis.—Dialysis deferral: 4 years so far”
Patients with Diseases of the Glomeruli:
 
“40-year-old laboratory technician, was referred for treatment of glomerulonephritis, known to be progressive for the previous 19 years. He was an avid jogger, running about 48 miles a week. Physical exam showed only high blood pressure. His serum creatinine level was quite high (5.5 mg per dl), as was his serum urea nitrogen level ... In response to a very low-protein diet supplemented by essential amino acids, serum urea nitrogen fell to 33 mg per dl. Dialysis deferral: 5 years”
 
“49-year-old hazardous waste engineer, gave a 18-year history of hypertension, with protein in the urine for at least eight years. Kidney function began to decline three years ago. A kidney biopsy showed IgA nephropathy. ... He was prescribed a very-low-protein diet, essential amino acids ... Dialysis deferral: 2 years”
 
On your shop.calwoodnutritionals.com website, on the Nutramine product page:
 
“Nutramine is USP grade amino acids formulated for nutrition in kidney diseasepatients and those with the early signs of kidney disease. Research shows protein restriction slows the progression of kidney failure…”
 
Information from your firm’s product brochures included with finished products upon shipment:
  1. Brochure for Nutramine-Amino Bites
“That makes them ideal to maintain normal nutritional values when on a diet restricted in any of these elements or protein. The recommended serving size (3.5 grams of essential amino acids per meal) is based on that Walser used to maintain normal nutritional status for patients treated with his low protein diet for pre-dialysis patients which he developed at the John Hopkins University…”
  1. Brochure for Nutramine
“NutramineTM is a nutritional supplement of USP grade amino acids for protein nutrition. The recommended serving size is based on that used by the Walser diet for pre-dialysis kidney patients developed at the John Hopkins University and should be taken 3 times daily…”
  1. Brochure for DialysAid
We have found that dialysis patients can increase their energy to the point that the hemodialysis day is also a good day by taking servings of the EAA at the appropriate times. It’s easy - take one serving of DialysAid 10 minutes before the end of your dialysis session…”
  1. Brochure for Nutrasentials Drink Mix
Nutrasentials Drink Mix is useful to maintain nutrition in individuals needed additional muscle synthesis such as: individuals who are cachectic due to burns, cancer, muscular dystrophy or AIDS; individuals who are on a defined diet such as the Walser diet for kidney patients…”
 
Your products are not generally recognized as safe and effective for the above referenced uses and therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the 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 submitted by a drug sponsor to demonstrate that the drug is safe and effective.
 
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended uses. “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 Amino Acid products Nutramine, DialysAid, Nutramine-Amino Bites, and Nutrasentials Drink Mix 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 your products safely for their intended purposes. Accordingly, these Amino Acid 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)].
 
Adulteration
 
Even if your Nutramine-Amino Bites product was not an unapproved new drug, it would still be an adulterated food under 402(c) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 342(c)] because the product label indicates that it bears or contains color additives which are unsafe within the meaning of section 721(a) of the Act [21 U.S.C. § 379e(a)]. Yellow #3 and #40 are non-permitted color additives. 
 
Misbranding
 
Even if your Nutramine-Amino Bites; Nutramine; Nutrasentials Drink Mix; and DialysAid products were not unapproved new drugs, the following varieties of the products would still be misbranded foods under section 403 of the Act [21 U.S.C. 343].  
  1. Your DialysAid Orange, Nutramine Essential Amino Acid Chewable Bites, and Nutrasentials Orange Essential Amino Acid Drink products are misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information (e.g. Nutrition Facts Panel) is not in a correct format, as required by 21 CFR 101.9:
a.    The Nutramine Essential Amino Acid Chewable Bites, Nutrasentials Orange Essential Amino Acid Drink, and DialysAid Orange product Nutrition Facts panel fails to list Protein or Sodium as required by 21 CFR 101.9(c)(7) and (4), respectively.
b.    You make a claim on your Nutramine Essential Amino Acid Chewable Bites with the statement “For complete protein nutrition. Contains no protein or phosphorous, with only 21 mg of potassium and 115 mg of sodium.” When making a claim related to the nutrient levels in a product, you must list those nutrients in the Nutrition Facts Panel as required by 21 CFR 101.13(b). Your Nutrition Facts panel does not list Protein, Sodium, Potassium or Phosphorus. Protein and sodium are required under 21 CFR 101.9(c)(7) and (4), respectively. The requirements to declare voluntary nutrients potassium and phosphorus are found in 21 CFR 101.9(c)(5) and (8)(ii), respectively.
c.    You make a claim on your Nutrasentials Orange Essential Amino Acid Drink with the statement “For complete protein nutrition. Contains no protein, no phosphorous, no sodium and no potassium!” When making a claim related to the nutrient levels in a product, you must list those nutrients in the Nutrition Facts Panel as required by 21 CFR 101.13(b). Your Nutrition Facts panel does not list Protein, Sodium, Potassium, or Phosphorus. Protein and sodium are required under 21 CFR 101.9(c)(7) and (4), respectively. The requirements to declare voluntary nutrients potassium and phosphorus are found in 21 CFR 101.9(c)(5) and (8)(ii), respectively.
d.    The serving size declared on the labels for the Nutrasentials Orange Essential Amino Acid Drink and DialysAid Orange may be confusing to consumers because the labels include conflicting common household measures for the serving size. For example, the common household measure is listed in the "Nutritional Information" statement for the Nutrasentials Orange Essential Amino Acid Drink and the DialysAid Orange states that it is to be a "heaping scoop;" however, in the Nutritional Facts panel, it is identified as "1 scoop." Further, in the directions for the Nutrasentials Orange Essential Amino Acid Drink product, it states that it is to be a "packed scoop."(21 CFR 101.9(b)).
e.    A percent Daily Value for trans fat cannot be declared in the nutrition label because there is no Daily Reference Value in 21 CFR 101.9(c)(9).
f    On your DialysAid Orange and Nutramine-Amino Bites product labels, there is no provision for the declaration of "Essential Amino Acids" or "Amino Acids/Serving" within the nutrition label (21 CFR 101.9(c) and (d)).
g.    On your DialysAid Orange and Nutrasentials Orange Essential Amino Acid Drink product labels, the units of measure for the nutrient values for Total fat, Saturated fat, Trans fat and cholesterol are not provided in accordance with 21 CFR 101.9(c).
h.    The serving size on the Nutramine Essential Amino Acid Chewable Bites does not meet the requirements in 21 CFR 10 1.9(b)(7) because it does not provide the gram weight.
i.    The Nutrition Facts panel is not in the correct format as required by 21 CFR 101.9(d). Examples of formatting issues include headings, hairlines, bars, bolding, and rounding of nutrients.
j.    The proper heading for this panel is “Nutrition Facts,” not “Nutritional Facts.” [21 CFR 101.9(d)(2)]
k.    Finally, the footnote is not in accordance with 21 CFR 10 1.9(d)(9). 
  1. Your DialysAid Orange and Nutramine Essential Amino Acid Chewable Bites products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. For example:
    1. For your DialysAid Orange, you list the ingredient “Essential Amino Acids” but fail to list the individual amino acids which comprise this ingredient. 21 CFR 10 1.4(b) does not provide for the generic term nor the collective listing of "essential amino acids." 
    2. There is no provision for the use of the term "EAA" in the Nutramine Essential Amino Acid Chewable Bites ingredient list. 
    3. There are no provisions for "and/or" statements for "citric/and/or malic acid," "may contain" statements for flavors or colors, nor the collective listing of colors in the Nutramine Essential Amino Acid Chewable Bites ingredient list. 
    4. There is no provision in 21 CFR 101.22 for the declaration of "#40" for any color in the Nutramine Essential Amino Acid Chewable Bites ingredient list.
  1. DialysAid Orange and Nutrasentials Orange Essential Amino Acid Drink products are misbranded within the meaning of section 403(i)(l) of the act because they do not include an appropriate statement of identity. We note that these products are drink mixes; however, the label for the Nutrasentials Orange Essential Amino Acid Drink product states that it is a drink and the label for the DialysAid Orange does not include any statement of identity.
The above list is not intended to be an all-inclusive list of deficiencies with your products, labels and labeling. It is your responsibility to ensure that your establishment is in compliance with all requirements of the Act and federal regulations. You should take prompt action to correct these deviations. Failure to take appropriate corrective action may subject your firm and products to regulatory action that can include seizure and/or injunction.
 
We also have the following comments regarding the labeling of your products:
  • The following types of usage instructions and the term “take” are not typically seen on a food product: the statements “Three servings per day Recommended” on the Nutramine Essential Amino Acid Chewable Bites, and “Take 2 times a day with meal or exercise” on the Nutrasentials Orange Essential Amino Acid Drink.  We also note that the brochure for “Nutramine” states “Nutramine is a nutritional supplement of USP grade amino acids...” which is also not typically seen on a food product.
The nutrition labels on your brochures:
 
• The nutrition labels on the brochures for your DialysAid, Nutramine-Amino Bites, and Nutrasentials Drink Mixproducts do not meet the requirements in 21 CFR 101.9 because they do not declare trans fat, sugars, or vitamin A. Furthermore, they include information that is not permitted within the nutrition label, such as "Protein as amino acids 3.5g" and "**Not digested and therefore not available as a source of calories".
 
You should notify this office in writing within fifteen (15) working days from your receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step taken to prevent recurrence. In your response, include documentation of your corrective actions or steps towards long term corrective actions. If you cannot complete all corrective actions before you respond, you should explain the reason for your delay and state when you will correct the remaining deficiencies.
 
Your written response should be sent to Ms. Evelyn Bonnin, Baltimore District Director, U.S. Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, MD 21215.If you have questions regarding any issues in this letter, please contact CDR Rochelle B. Young, RPh, MSA, Compliance Officer at (410) 779-5437.
 
Sincerely,
/S/ 
Evelyn Bonnin
Baltimore District Director

Page Last Updated: 02/08/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English