WARNING LETTER
DSE Healthcare Solutions, LLC MARCS-CMS 508212 —
- Recipient:
- DSE Healthcare Solutions, LLC
United States
- Issuing Office:
- New Jersey District Office
United States
| |
New Jersey District Office 10 Waterview Blvd. 3rd Floor Parsippany, New Jersey 07054 |
WARNING LETTER
March 16, 2017
VIA UNITED PARCEL SERVICE 17-NWJ-06
SIGNATURE REQUIRED
Mr. Moaiz F. Daya, President/Partner
DSE Healthcare Solutions, LLC
105 Fieldcrest Avenue
Edison, New Jersey 08837
Dear Mr. Daya:
From August 9, 2016, through August 25, 2016, the U.S. Food and Drug Administration (FDA or we) conducted an inspection of your facility located at 105 Fieldcrest Avenue, Edison, New Jersey. Our inspection revealed significant violations of Title 21 of the Code of Federal Regulations, Part 111 (21 CFR Part 111), Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. These violations 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)] in that they have been prepared, packed, or held under conditions that do not meet the current good manufacturing practice regulations for dietary supplements found under 21 CFR Part 111.
In addition, FDA reviewed your product labels collected during our inspection and your websites at the internet addresses www.dsehealthcare.com, www.prelief.com and www.urinozinc.com. Based on our review, we have concluded that certain products are in violation of sections 403, 505(a), and 502(f)(1) of the Act [21 U.S.C. §§ 343, 355(a), and 352(f)(1)] and regulations implementing the food labeling requirements of the Act, which are found in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101).
You can find the Act and FDA regulations through links on FDA’s website at www.fda.gov.
Unapproved New Drugs and Misbranded New Drugs
In January 2017, we reviewed your product labels for several of your products, including Urinozinc Prostate Health Formula and Prelief, and we reviewed your websites at the internet addresses www.dsehealthcare.com, www.prelief.com and www.urinozinc.com, where you take orders for and/or where you provide links to a website from which consumers can purchase these products.
The therapeutic claims on your product labels and websites establish that the Urinozinc Prostate Health Formula and Prelief products are drugs under sections 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 claims that provide evidence that these products are intended for use as drugs include:
“Urinozinc Prostate Health Formula”:
On the product label:
• “Are you experiencing any of these symptoms? . . . Pain of discomfort while urinating or ejaculating . . . Frequent urination . . . weak or interrupted urinary stream”
On your product website, www.urinozinc.com, which is listed on your product label and where there are links to buy the product:
• “Pumpkin seed extract [an ingredient in the product] . . . provides key nutrients for an enlarged Prostate”
• “Beta-Sitosterol [an ingredient in the product] . . . Mixtures of plants containing Beta-sitosterol are accepted cholesterol-lowering agents, but they have also been shown to improve symptoms associated with an enlarged prostate”
• “An enlarged prostate is the major cause of frequent urination . . . the prostate can constrict the flow of urine”
• “If you’re a man and are experiencing the symptoms of an enlarged prostate . . . URINOZINC may be right for you”
Prelief:
On the product label:
• “Taking Prelief . . . can often stop [foods] from causing painful bladder symptoms”
On your website www.prelief.com, which is listed on your product label and where there are links to buy the product:
• “Urinary Urgency and Bladder Discomfort Caused By Foods”
• “Prelief has found special uses in the diets of individuals with food acid-aggravated conditions that can result in urinary bladder problems.”
• “Independent urology studies from major researchers and hospital conclude the following . . . Prelief is the most desirable and least compromising way of dealing with food triggered bladder discomfort.”
• “What to use Prelief for . . . Removing up to 95% of acid from trigger foods which may result in bladder discomfort …. indigestion…”
• “If acid foods bother your bladder it could be interstitial cystitis. Prelief® Dietary Supplement may help manage your bladder discomfort.”
Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of Prelief for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:
• “From unbearable pain to active Mom again . . . I had been suffering from bladder pain for years . . . I was recently diagnosed with possible IC [interstitial cystitis] . . . I researched online and came across the suggestion that your product Prelief can be used to ease bladder pain . . . within a day of taking 2 pills before every meal and snack, my pain has decreased”
• “I have suffered with bladder problems for years . . . the doctor sent me to a Urologist . . . Instead of giving me a prescription for more drugs he suggested I try this Prelief . . . I take some before each meal and I have been without a problem ever since . . . it not only protects my bladder but now my acid reflux is so good I don’t take any more antacids either . . . It’s so nice to be able to use something natural instead of another drug”
In addition, your website www.prelief.com includes the tab “Medical Studies and Articles” which contains the statement, “Articles containing citations of calcium glycerophosphate [the primary ingredient in Prelief] or Prelief are marked with*.” When scientific publications are used commercially by the seller of a product to promote the product to consumers, such publications may become evidence of the product's intended use. For example, under 21 CFR 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a product is considered to be a claim about disease treatment or prevention if the citation refers to a disease use and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease. The following are examples of reference citations used to market your products for disease treatment and prevention on your website that are marked with an asterisk and are thus evidence of your products' intended use as drugs:
• Treating Interstitial Cystitis/Bladder Pain Syndrome as a Chronic Disease; Bosch, P., Bosch D., Reviews in Urology, Vol. 16, No. 2, 2014*
• Complementary and Alternative Medications for Chronic Pelvic Pain; Che Leong, F., Obstetrics and Gynecology Clinics of North America, 41, 503-510, 2014*
• Interstitial Cystitis, Painful Bladder Syndrome, Bladder Pain Syndrome, Hypersensitive Bladder Syndrome, Chronic Pelvic Pain, Diagnosis & Treatment – an Overview; Meijlink, Jane M; Intl Painful Bladder Found, IPBF Publ No 1; Aug 2011*”
Your Urinozinc Prostate Health Formula and Prelief products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” as defined in section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data 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 use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 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 products Urinozinc Prostate Health Formula and Prelief 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, your Urinozinc Prostate Health Formula and Prelief 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)].
Adulterated Dietary Supplements
Your dietary supplement products are adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] in that they have been prepared, packaged, or held under conditions that do not meet the CGMP regulation for dietary supplements (21 CFR Part 111). Additionally, even if your Urinozinc Prostate Health Formula and Prelief products did not have therapeutic claims which make them unapproved new drugs, these products would be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. §342(g)(1)] in that they have been prepared, packed, or held under conditions that do not meet the CGMP regulation for dietary supplements (21 CFR Part 111).
We understand that you are responsible for the formulation of all of your products and that you contract with other manufacturers to perform certain operations relating to products that are distributed into interstate commerce under your firm’s name. Furthermore, we understand that your firm is responsible for the labels for your products and that you contract with another firm that reviews your product labels. That firm, however, does not approve the release of your products for shipment into interstate commerce. To the extent that you contract with other firms to manufacture, package, and/or label product on your behalf that your firm releases for distribution under your firm’s name, your firm has an obligation to know what and how manufacturing, packaging, and/or labeling 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, packaging, and/or labeling 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). Further, 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)).
The inspection revealed the following significant violations of the CGMP requirements for dietary supplements:
1. You failed to establish specifications for each dietary supplement for the identity, purity, strength, and composition of the finished batch of the dietary supplements, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement to ensure the quality of each dietary supplement, as required by 21 CFR 111.70(e). During the inspection, your management informed the investigator that you establish the formulation of all of your products. However, your firm’s specification for Prelief fails to include identity and purity specifications, as well as limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement. Additionally, your Prelief specification includes, “Assay (Calcium Glycerophosphate)” of “(b)(4).” According to the finished product label, calcium glycerophosphate is the source of the calcium and phosphorus dietary ingredients. However, your finished product specification does not include specifications for the calcium and phosphorous dietary ingredients in the product, or an explanation of the relationship between the calcium glycerophosphate assay level and the level of calcium and phosphorus dietary ingredients in the product.
Moreover, your Prelief’s calcium and phosphorus dietary ingredients are Class I nutrients as defined in 21 CFR 101.9(g)(3)(i), in that they are nutrients that are added to a fortified or fabricated food. As such, they should be present in the finished product at least 100% of the value of that nutrient as declared on the label. Your specification does not provide information regarding to what the “(b)(4)” requirement refers, such as potency or weight; therefore, it is unclear how an assay of (b)(4) of the calcium glycerophosphate ingredient can provide 100% or more of the declared value of the calcium and phosphorus dietary ingredients it supplies.
2. You failed to satisfy the requirements for the review and investigation of product complaints, as required by 21 CFR 111.560(a). Your complaint log reveals that you received thirty complaints in calendar year 2015 and fifteen complaints from January to August 2016. However, your management stated that your firm only investigates complaints involving (b)(4). Limiting the review of investigations of product complains in this manner is insufficient, as 21 CFR 111.560(a)(1) requires review of all product complaints to determine whether the product complaint involves a possible failure of a dietary supplement to meet any of its specifications, or any other requirements of 21 CFR Part 111, including those specifications and other requirements that, if not met, may result in a risk of illness or injury.
We have received your response, dated September 9th, 2016; however, we are unable to evaluate the sufficiency of your corrective action. Your letter suggests that there was a misunderstanding as to whether your firm investigated complaints because there was no indication of such on the complaint log, and that the complaint log has been updated. However, we are unable to evaluate whether your firm completed investigations related to product complaints required by 21 CFR 111.560(a) because your letter did not include evidence that all complaints required to be investigated have been investigated by your firm, such as examples of records of investigations that you have conducted. We will evaluate the adequacy of your complaint investigations at our next inspection.
Misbranded Dietary Supplements:
Your Lydia Pinkham Herbal Tablet Supplement and Lydia Pinkham Herbal Liquid Supplement products are misbranded under section 403 of the Act [21 U.S.C. § 343] because their labels do not comply with FDA’s labeling regulations under 21 CFR Part 101, as follows:
1. Your Lydia Pinkham Herbal Tablet Supplement product is misbranded within the meaning of sections 403(q)(1)(B) [21 U.S.C. §343(q)(1)B] and 403(q)(5)(F) of the Act [21 U.S.C. 343 (q)(5)(F)] because the label fails to declare the number of servings per container, in accordance with 21 CFR 101.36(b)(1)(ii).
2. Your Lydia Pinkham Herbal Tablet Supplement product is misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages, but does not repeat all the required information in both languages, in accordance with 21 CFR 101.15(c). For example, the Supplement Facts information, ingredients, net contents, and name and address of the distributor must be declared in both the English and foreign languages.
3. Your Lydia Pinkham Herbal Liquid Supplement product is misbranded within the meaning of section 403(k) of the Act [21 U.S.C. § 343(k)] because the product bears or contains an artificial coloring, flavoring, or a chemical preservative but does not bear labeling stating that fact. Specifically, the product label lists BHA in the ingredient statement. In accordance with 21 CFR 101.22(j), when an approved food preservative is added to a food, the ingredient list must include both the common or usual name of the food additive and the function of the preservative by including terms, such as “preservative,” “to retard spoilage,” “a mold inhibitor,” “to help protect flavor,” or “to promote color retention.”
The above violations are not intended to be an all-inclusive list of violations at your facility or 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 ensure that all of your firm’s products are in compliance with the Act and its implementing regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in enforcement action by FDA without further notice, such as seizure or injunction.
In addition, we have the following labeling comments:
• Your Lydia Pinkham Herbal Tablet Supplement and Lydia Pinkham Herbal Liquid Supplement 8 and 16 oz. product labels fail to bear an accurate statement of the net quantity of contents in terms of weight designated in both U.S. Customary and metric terms in accordance with 21 CFR 101.105. Specifically, each product label does not bear the statement of the net quantity of contents in terms of weight designated in metric terms. The net weight in terms of metric terms is required under the Fair Packaging and Labeling Act.
• Your Lydia Pinkham Herbal Tablet Supplement and Lydia Pinkham Herbal Liquid Supplement 8 and 16 oz. product labels indicate the ingredient “pleurisy”. This is not a standardized common name as noted in Herbs of Commerce. The common or usual name of ingredients of dietary supplements that are botanicals shall be consistent with names standardized in Herbs of Commerce. 21 CFR 101.4(h).
• The standardized common name “motherwart” is incorrectly spelled on your Lydia Pinkham Herbal Tablet Supplement and Lydia Pinkham Herbal Liquid Supplement 8 and 16 oz product labels.
You should notify this office in writing within fifteen working days of receipt of this letter of the specific steps that you have taken to correct violations, including an explanation of each step taken to prevent the recurrence of violations and copies of supporting documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the date by which you will have completed the correction. Section 743 of the Act, 21 U.S.C. § 379j-31, authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees, 21 U.S.C. § 379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
Your response should be sent to the following address: U.S. Food and Drug Administration, 10 Waterview Blvd., 3rd Floor, Parsippany, New Jersey 07054. If you should have any questions regarding any issue in this letter, please contact Andrew Ciaccia, Compliance Officer.
Sincerely,
/S/
Craig Swanson
Acting District Director
New Jersey District