Inspections, Compliance, Enforcement, and Criminal Investigations

Nature's Health, LLC 12/2/15

  

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

Public Health Service
Food and Drug Administration
 
Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
Telephone: 303-236-3000              
FAX:        303-236-3100

 

December 2, 2015
 
WARNING LETTER
 
 
VIA UPS Overnight Delivery
 
Ref: DEN-16-02-WL
 
Lawrence Lim, Owner
Nature’s Health, LLC
2212 S. West Temple, Ste. 10
Salt Lake City, UT 84115
 
Dear Mr. Lim:
 
On March 30-31, 2015, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 2212 S. West Temple, Ste. 10, Salt Lake City, Utah. Based on the inspection, a review of product labels collected during the inspection, and review of your website www.natureshealth.com, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the FDA regulations and the Act through links on FDA’s home page at http://www.fda.gov.
 
We have reviewed your undated, written response received on May 8, 2015 submitted in response to the FDA-483 issued to you at the close of the inspection. We have included some detailed comments regarding your response below.
 
Unapproved New Drugs
 
FDA reviewed your website at the Internet address www.natureshealth.com in October 2015, and has determined that you take orders there for the products Ginkgo & Rhodiola, Blood Sugar Balance IV, Cinnamon Extract, Choles-Balance Red Yeast Extract, Lecithin, Milk Thistle Seed Extract, Intestine Relaxer I for IBS, Intestine Relaxer II (for crohns), Red Sage, Selfheal, BUN Balance, Bronchi Relaxer I, Lung Cleaner II, Hyper-care, Hypo-care,St. John’s Wort, Standardized Valerian Extract, Head Relaxer I, Head Relaxer II, Urinary Balance,and Urinary Balance II,we have determined that these products are promoted for conditions that cause them to be drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your website and product labels establish that these 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.
 
Your website has three categories of drop-down menus: Treat by Health Concern, Treat by Area, and Treat by Symptom. Examples of some of the website claims in these three categories that provide evidence your products are intended for use as drugs include:
 
Treat by Health Concern 
  • “Blood Sugar” link directs to these products:
    • Blood Sugar Balance IV
      • “Blood Sugar Balance is a [sic] formulated to help reduce blood glucose levels.”
      • “Clinical trials have shown Gymnema Sylvestre to be effective against type 1 and type 2 diabetes.”
      • “Fructus Corni…has been shown in tests to help prevent renal failure. Studies have shown that Fructus Corni can significantly decrease blood glucose levels and urinary protein levels, preventing damage to the kidneys.”
    • Cinnamon Extract
      • “Cinnamon Extract may also be used to lower bad cholesterol levels (LDL)…”
  • “Cholesterol” link directs to these products:
    • Choles-Balance Red Yeast Extract
      • “Cholesterol Balance contains red yeast rice extract, which may lower blood cholesterol, low-density lipoprotein (LDL or bad cholesterol) levels…”
      • “Red yeast rice inhibits the action of an enzyme in the body that helps make cholesterol and is extremely effective.”
    • Lecithin
      • “Lecithin has been used to treat gallbladder disease, gallstones, liver disease, depression…high cholesterol levels, and skin diseases such as psoriasis and eczema.”
      • “[M]ay…potentially help treat memory disorders such as dementia and Alzheimer’s disease.”
Treatment by Area
  • “Bowel” link directs to these products:
o   Intestine Relaxer I for IBS [product name is implied disease claim]
 
o   Intestine Relaxer II (for crohns) [product name is implied disease claim]
  • “Heart” link directs to these products:
o   Red Sage
  •  “It has been used to treat high blood pressure (hypertension), heart conditions, chest pains and may also reduce bad cholesterol in the body (LDL). Overall circulation in the body is improved by expansion of the blood vessels and thinning of blood.”
o   Selfheal
  • “Other benefits of Selfheal may include lowering high blood pressure (hypertension) as well as decrease swelling (inflammation)…”
  • “Kidney” link directs to the product BUN Balance 
o   “B.U.N. Balance can help improve kidney functions [by] lowering the amount of blood urea nitrogen.”
  • “Liver” link directs to the product Milk Thistle Seed Extract 80% Silymarin
o   “Silymarin is known to relieve symptoms of … acute and chronic hepatitis, cirrhosis, fatty liver and damage.”
 
  • “Mind Health” link directs to the product Ginko & Rhodiola
o   “[T]reat Raynaud’s syndrome (sensitivity to cold especially in the fingers and toes).”
 
o   “Rhodia rosea may help reduce depression symptoms, prevent altitude sickness…”
  • “Respiratory System” link directs to these products:
o   Bronchi Relaxer I
 “Bronchi Relaxer may be beneficial for those with asthma or asthma like symptoms.”
 
o   Lung Cleaner II
 “Lung Cleanser II is recommended for those with chronic inflammation in the lungs.”
“Many asthma sufferers will experience a dry cough, primarily at night and Lung Cleanser II may reduce non-productive or dry coughing.”
 
Treat by Symptom
  • “Autoimmune Disorder” link directs to these products:
o   Hyper-care
[F]or Hyperthyroid”
 
o   Hypo-care
“[F]or Hypothyroid”
  • “Depression” link directs to these products:
o   St. John’s Wort
“It is most commonly used to…treat mild to moderate depressions as well as the symptoms that may go along with it such as anxiety, difficulties sleeping, tiredness, and loss of appetite.”
“Studies have shown that St. John’s Wort, when used to treat mild to moderate depression may be just as effective as an anti-depressant.”
 
o   Standardized Valerian Extract
“Valerian…use…to help those suffering from insomnia…Other uses for valerian may include treating migraines…anxiety, depression…”
  • “Headaches” link directs to these products:
o   Head Relaxer I
“[P]rovide relief from headaches…include migraines or less intense usual headaches.”
 
o   Head Relaxer II
“[P]rovide relief from headaches… include migraines or less intense usual headaches.”
  • “Urinary” link directs to these products:
o   Urinary Balance
“[F]or Urinary Tract infection”
“May be effective in reducing infection of the urinary system, kidneys, bladder or fallopian tubes.”
 
o   Urinary Balance II
“[F]or Urinary Incontinence”
 
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)(1) of the Act [21 USC § 321(p)(1)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the Act [21 USC §355(a)]; see also section 301(d) of the Act [21 USC §331(d)].  FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate the drug is safe and effective.
 
Furthermore, your products Ginko & Rhodiola, Blood Sugar Balance IV, Lecithin, Intestine Relaxer I (for IBS), Intestine Relaxer II (for crohns), Red Sage, Selfheal, Bronchi Relaxer I, Lung Cleaner II, Hyper-care, Hypo-care,St. John’s Wort, Standardized Valerian Extract, Urinary Balance and Milk Thistle Seed Extracts are offered for conditions that are not amendable to self-diagnosis or treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purpose. Thus, these drugs are misbranded within the meaning of section 502(f)(1) of the Act, in that their labeling fails to bear adequate directions for use [21 U.S.C. § 352 (f)(1)]. 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)].
 
Adulterated Dietary Supplements
 
Even if your Ginkgo & Rhodiola, Blood Sugar Balance IV, Cinnamon Extract, Choles-Balance Red Yeast Extract, Lecithin, Milk Thistle Seed Extracts, Intestine Relaxer I for IBS, Intestine Relaxer II (for crohns), Red Sage, Selfheal, BUN Balance, Bronchi Relaxer I, Lung Cleaner II, Hyper-care, Hypo-care,St. John’s Wort, Standardized Valerian Extract, Head Relaxer I, Head Relaxer II, Urinary Balance, and Urinary Balance II products did not have therapeutic claims which make them unapproved new drugs, these products would still be adulterated dietary supplements within the meaning of section 402(g)(1) [21 U.S.C. §342(g)(1)] of the Act because the products have been prepared, packed, or held under conditions that do not meet the current good manufacturing practice (cGMP) regulations for dietary supplements. Further, your Bronchi Relaxer II, Liver-Kidney Balance, Rubber Tree (Eucommia Bark) and Wormwood Oriental products and all dietary supplement products you manufacture are adulterated within the meaning of section 402(g)(1) [21 U.S.C. § 342(g)(1)] of the Act for the reasons described below.
 
The signification violations documented during the inspection include, but are not limited to, the following:
 
1.    You failed to establish product specifications for each dietary supplement you manufacture, for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of dietary supplement, as required by 21 CFR 111.70(e). Specifically, your firm distributes approximately 100 different dietary supplement products, but you only provided written specifications for four finished products. Once you have established product specifications, you must determine whether these specifications are met (21 CFR 111.73) by testing the finished batch of dietary supplement in accordance with testing requirements in 21 CFR 111.75(c). 
 
We have reviewed your undated written response received on May 8, 2015. We are unable to determine the adequacy of your response. Although you indicate in the response that you have all the specifications in place, you did not provide documentation to support your response (e.g. copies of written specifications).
 
2.    Your firm failed to verify that your finished batches of dietary supplements meet product specifications for identity, purity, strength, and composition, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of dietary supplement, as required by 21 CFR 111.75(c). Specifically, your firm does not conduct any testing on finished dietary supplement products before releasing the products for distribution, including, Liver-Kidney Balance, Bronchi Relaxer II, and Uric Acid Balance.
 
We have reviewed your undated written response received on May 8, 2015, however, we are unable to determine the adequacy of your response.. Your response indicated that you are now working with a local lab to determine pricing, procedures, and timeframes for finished product testing (b)(4). However, you neither provided a timeline as to when finished product testing would begin nor did you include the specific tests or acceptance criteria related to the identity, purity, strength, and composition of each dietary supplement manufactured by your firm.
 
3.    You failed to establish an identity specification for each component used in the manufacturing of your dietary supplements, as required by 21 CFR 111.70(b)(1), and you failed to establish component specifications that are necessary to ensure that specifications for the purity, strength, and composition of dietary supplements manufactured using components are met, as required by 21 CFR 111.70(b)(2).
 
For example, of the three products selected for review, you did not establish written component specifications for the following ingredients:
  • Herba Artemisia capillaris in your Wormwood product
  • Poria cocos, Cortex moutan, and Radix rehmanniae powder in your Liver-Kidney Balance product
  • Radix sophorae flavescentis in your Bronchi Relaxer II product
We have reviewed your undated written response received on May 8, 2015. We were unable to determine the adequacy of your response. You indicate in the response that you have all the specifications in place, but you did not provide documentation to support your response (e.g. copies of written specifications).
 
4.    Your firm failed to conduct at least one appropriate test or examination to verify the identity of a component that is a dietary ingredient prior to its use as required by 21 CFR 111.75(a)(1)(i). Specifically, your firm performs (b)(4) examination (b)(4) on dietary ingredients, such as Herba Artemisia capillaris, Poria cocos, Cortex moutan, and Radix rehmanniae powder, and Radix sophorae flavescentis, to verify identity. As part of the examination, you reference information about the dietary ingredient from the (b)(4). For ingredients not included in the pharmacopoeia, you verify the identity of the dietary ingredient on (b)(4). Of the three products selected for review, verification of identity was performed using the latter method for the ingredient Radix rehmanniae powder in your Liver-Kidney Balance product; however, it is not possible to verify the identity of a botanical powder by (b)(4) testing.
 
We have reviewed your undated written response received on May 8, 2015. We have determined that your response is inadequate. You indicate in the response “I will continue performing (b)(4) testing on the raw materials…to satisfy the identity portion of the test.” However, as stated above, it is not possible to verify the identity or the purity, strength, composition, and absence of contaminants that may adulterate your product by (b)(4) testing. Furthermore, you did not provide documentation to demonstrate that you completed the identity testing for all components used in your Bronchi Relaxer II, Liver-Kidney Balance and Wormwood Oriental dietary supplement products. 
 
5.    Your batch production records (BPRs) did not include complete information relating to the production and control of each batch of your Bronchi Relaxer II (lot 1400807), Liver-Kidney Balance (lot 1400604), and Wormwood Oriental (lot 1401207) dietary supplement products, as required by 21 CFR 111.255(b) and 21 CFR 111.260. Specifically, your BPRs did not include the following required information:
  • The unique identifier that you assigned to packaging and labels used, the quantity of the packaging and labeling used, and when label reconciliation is required, reconciliation of any discrepancies between issuance and use of labels as required by 21 CFR 111.260(k)(1).
  • An actual or representative label, or a cross-reference to the physical location of the actual or representative label specified in the master manufacturing record as required by 21 CFR 111.260(k)(2).
In addition, the BPR for your Wormwood Oriental (lot 1401207) product did not include documentation that the lot of finished product met the specifications established in accordance with § 111.70(e) and (g), as required by 21 CFR 111.260(i).
 
We have reviewed your undated written response received on May 8, 2015. We were unable to determine the adequacy of your response because you did not include batch records for our review that demonstrate that you have implemented the above referenced requirements.
 
6.    You failed to prepare and follow written master manufacturing records (MMR) for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205(a). Specifically, your firm did not prepare MMRs for each unique dietary supplement that you manufacture.
 
We have reviewed your undated written response received on May 8, 2015. We are unable to determine the adequacy of your response because you did not provide supporting documentation to demonstrate the corrective action was taken. Your response indicated that every formulation manufactured has a master manufacturing record; however, you did not include master manufacturing records for our review that demonstrate that you have implemented the above-referenced requirements. 
 
7.    Your master manufacturing records (MMRs) for your Bronchi Relaxer II and Wormwood Oriental products did not include the following required information, as required by 21 CFR 111.210:
    • The identity and weight or measure of each dietary ingredient that will be declared on the Supplement Facts label and the identity of each ingredient that will be declared on the ingredients list of the dietary supplement as required by 21 CFR 111.210(d).
    • A statement of theoretical yield of a manufactured dietary supplement expected at each point, step, or stage of the manufacturing process where control is needed to ensure the quality of the dietary supplement, and the expected  yield when you finish manufacturing the dietary supplement including the maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary and material review is conducted and disposition decision is made as required by 21 CFR 111.210(f)
    • A description of packaging and a representative label, or a cross-reference to the physical location of the actual or representative label as required by 21 CFR 111.210(g).
    • Procedures for sampling and a cross-reference to procedures for tests or examinations as required by 21 CFR 111.210(h)(2).
    • Corrective action plans for use when a specification is not met as required by 21 CFR 111.210(h)(5).
We have reviewed your undated written response received on May 8, 2015. We were unable to determine the adequacy of your response because you did not include any master manufacturing records for our review that demonstrate that you have implemented the above-referenced requirements.
 
Misbranded Dietary Supplements
 
Your Bronchi Relaxer II, Liver-Kidney Balance,  and Wormwood Oriental are misbranded dietary supplements under section 403 of the Act [21 U.S.C. § 343] because they do not comply with the labeling requirements for dietary supplements. The inspection revealed the following violations of labeling requirements for dietary supplements:
 
1.    Your Bronchi Relaxer II, Liver-Kidney Balance and Wormwood Oriental products are misbranded within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because the labels fail to include a statement of identity as a “dietary supplement” as required by 21 CFR 101.3(g).
 
2.    Your Bronchi Relaxer II, Liver-Kidney Balance, and Wormwood Oriental products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the products are contained in capsules, but the capsule ingredients are not listed on the labels, as required by 21 CFR 101.4(g).
 
3.    Your Liver-Kidney Balance product is misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving size declared on the label is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. The directions of use suggest the consumer take one or two capsules with water three times daily after meals, but the serving size lists 1 capsule. The serving size listed should be two capsules.
 
4.    Your Wormwood Oriental product is misbranded within the meaning of section 403(q)(5)(F) and 403(s)(2)(A) of the Act [21 U.S.C. § 343 (q)(5)(F) and 21 U.S.C. § 343(s)(2)(A)] in that the label fails present nutrition information, including the common or usual name of capillansin along with the quantitative amounts by weight per serving in metric units of both capillansin and 6,7-dimethylesculetin, as required by 21 CFR 101.36(b)(3). 
 
5.    Your Bronchi Relaxer II, Liver-Kidney Balance, and Wormwood Oriental products are misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)] because the labels fail to include a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplements. “Domestic address or domestic phone number” means a complete address or phone number. The labels for these products do not include complete addresses or phone numbers.
 
(b)(3)
 
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law 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, injunction or prosecution.
 
Section 743 of the Act [21 U.S.C. 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection related costs means all expenses, including administrative expenses incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection related costs.
 
Within 15 working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the violations. You should 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 a corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
 
Your written response should be directed to the U.S. Food and Drug Administration, Attention: Hanna L. Potter, Compliance Officer, at the above address. If you have questions about this letter, please contact Ms. Potter at (303) 236-3094.
 
Sincerely,
/S/
LaTonya M. Mitchell
Denver District Director

 

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