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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Los Angeles District
Irvine, CA 92612-2506
RETURN RECEIPT REQUESTED
October 11, 2011 W/L 01-12
6225 Progressive Drive, #200
San Diego, California 92154
Dear Mr. Garcés:
The United States Food and Drug Administration (FDA) conducted an inspection of Nordimex, LLC., located at 6225 Progressive Drive #200, San Diego, California on May 12, 2011 to May 31, 2011. Our review of these products labeling and promotional claims shows other serious violations of the Act under sections 505, 502, and 403 of the Act [21 U.S.C. §§ 355, 352 and 343]. In addition, our inspection revealed serious violations of FDA’s Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements (CGMP) regulations for Dietary Supplements, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause your 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 these products have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.
You may find the Act and FDA regulations through links on FDA's home page at http://www.fda.gov
Unapproved New Drugs
Your Leche de Alpiste, Angin Original Formula, Broncolin Plus, Colesstol 200 and 400, Delgadex Fem, Desin-Flanax 850 XtraForte, Dolo Neuro Xtra Forte, Pentrexcilina Citricillin 500, Pharma+Fem, Pharma+Men, SedalFort Migraine, Super Sleeper Liquid Melatonin 50mg, and XXL-6 Fast Relief Effervescent Cold Remedy products are promoted for conditions that cause them to be drugs within the meaning of section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your product labeling and on your website establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act.
Examples of some of the translated claims observed in your product labeling include:
Leche de Alpiste
- “[A]ids in eliminating diabetes … prevents atherosclerosis … aids in cases of gout … gastritis and stomach ulcers … ideal for combating hypertension … extraordinary remedy for obesity”
Angin Original Formula
- (brochure) “[C]uring angina, throat infection, pain and irritation caused by … infection.”
- “Aids in discomfort of airways caused by … colds … ”
Colesstol 200 and 400
- “[H]elping to reduce cholesterol in an important manner, the principal cause of heart attacks. The evidence of the benefits is strong enough that FDA has allowed the label statement of “heart healthy.”
- “[K]nown for … treating fever, intestinal infections … ”
- “[A]nticancer … ”
Desin-Flanax 850 XtraForte
- "Pain Relief & Anti-Inflammatory Caps Arthritis & Reumatism [sic]”
Dolo Neuro Xtra Forte
- “It is an effective muscle anti-inflammatory … ”
Pentrexcilina Citricillin 500
- “Fast relief of most common infections”
- “Pentrexcilina is a 100% natural medication that helps prevent infections … ”
- “Scientific research shows that illnesses such as osteoporosis and breast cancer are every time more frequent in women older than 30 years of age, for which it is recommended to consume wild yam, black cohosh, folic acid, calcium and other nutrients [in your product] that reduce the risk of developing these illnesses.”
- “Scientific research shows that prostate cancer is diagnosed most frequently in men older than 40 years of age, for this reason the consumption of saw palmetto and lycopene [ingredients in your product] is suggested as a way to reduce the risk of developing prostate cancer.”
- “[B]est natural alternative against pain.”
- “The natural pain reliever”
- The name of the product, “Migraine”
Super Sleeper Liquid Melatonin 50mg
- “Enhances Insomnia problems”
XXL-6 Fast Relief Effervescent Cold Remedy
- “Cold, Flu & Allergies”
- “Fast Relief Effervescent Cold Remedy”
- Fast relief of: sneezing, runny nose, body pain, allergies, nasal congestion, sinus pain and pressure”
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” as defined by section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
Furthermore, your Leche de Alpiste, Angin Original Formula, Colesstol 200 and 400, Delgadex Fem, Pentrexcilina Citricillin 500, Pharma+Fem, Pharma+Men, and Super Sleeper Liquid Melatonin 50mg products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, these products are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that the 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)].
Even if your products did not contain disease claims in their labeling that cause them to be drugs, they would still be adulterated and misbranded dietary supplements, based on the following violations:
Dietary Supplement CGMP Violations
Your products Alpiste, Angin, Angin Xtra Forte, Broncolin Plus, Colesstol 200, Colesstol 400, Delgadex, Delgadex Fem, Desin-Flanex 850, Duro Neuro Extra Forte, Pentrexcilina Citricilina, Pharm+Fem, Pharm+Men, Sedal Fort, Super Complejo B, Super Sleeper Melatonina, and XX-6 are 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 these products have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.
Specific violations of 21 CFR Part 111 observed during the inspection include, but are not limited, to the following:
1. You failed to establish specifications, as required by 21 CFR 111.70. Specifically:
- You failed to established specifications for the dietary supplement labels and packaging you design and used on your dietary supplements as an own label distributor (21 CFR 111.70(d)).
- You failed to establish specifications for the packaging and labeling of the finished packaged and labeled dietary supplement for labels you receive and apply as an own label distributor (21 CFR 111.70(g)).
2. You failed to have quality control operations for components, packaging, and labels before use in the manufacture of a dietary supplement, as required by 111.120. Specifically, you failed to have quality control operations for reviewing all receiving records for packaging and labels [21 CFR 111.120(a)]; determining whether all packaging and labels conform to packaging and label specifications [21 CFR 111.120(b)]; approving or rejecting any treatment and in-process adjustments of packaging and labels to make them suitable for use in the manufacture of a dietary supplement [21 CFR 111.120(d)]; and approving and releasing from quarantine all packaging and labels before they are used [21 CFR 111.120(e)].
3. You failed to establish written procedures for subpart G, as required by 21 CFR 111.153. Specifically, you indicated that you receive labels that are used to label finished dietary supplement products at your facility. Therefore, your written procedures must also address requirements under 21 CFR 111.160.
Misbranded Dietary Supplements
1. Your Angin Original Formula, Angin Xtra Forte, Desin Flanax 850, Dolo Neuro Xtra Forte, Pentrexcilina Citricillin 500, Pharma+Fem, Pharma+Men, Super B Complex Stress Relief, Super Sleeper Liquid Melatonin 50mg, and XXL-6 Fast Relief Effervescent Cold Remedy products are misbranded within the meaning of sections 403(i)(1) and 403(s)(2)(B) of the Act [21 U.S.C. §§ 343(i)(1) and 343(s)(2)(B)] in that their labels fail to identify the products using the term 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.
2. Your products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the presentation of nutrition information on the labeling for your products does not comply with 21 CFR 101.36. Examples of violations of the requirements of 21 CFR 101.36 include:
- The label for your Leche de Alpiste product fails to bear nutrition labeling (“Supplement Facts” panel) as required by 21 CFR 101.36, and does not appear to be exempt from this requirement. Under 21 CFR 101.36(h), dietary supplements are subject to certain exemptions if they meet the following criteria set forth in 21 CFR 101.36(h)(1): (1) they are offered for sale by a person who makes direct sales to consumers who has annual gross sales or business done in sales to consumers that is not more than $500,000 or has annual gross sales made or business done in sales of food to consumers of not more than $50,000, and (2) their labels, labeling, and advertising do not provide nutrition information or make a nutrient content or health claim.
- The labels for your Broncolin Plus, Dolo Neuro Xtra Forte, Pharma+Fem, Pharma+Men, and Super B Complex Stress Relief, products fail to list the dietary ingredients under 21 CFR 101.36(b)(2) in the order required by 21 CFR 101.36(b)(2)(i)(B).
- The labels for your Angin Original Formula, Broncolin Plus, Dolo Neuro Xtra Forte, Pharma+Fem, Pharma+Men, Super B Complex Stress Relief products list both dietary ingredients with an established Reference Daily Intake (RDI) (e.g., Zinc, Magnesium, Niacin, etc.) and dietary ingredients for which FDA has not set a Daily Reference Value (DRV) or RDI (e.g., CoQ10, Lycopene, Methylsulfonymethane, etc.), as defined by 21 CFR 101.36(b)(2) and (b)(3), respectively. However, the 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). Additionally, the labels fail to include heavy bars beneath the last dietary ingredient required to be declared pursuant to 21 CFR 101.36(b)(2) and (b)(3), respectively (21 CFR 101.36(e)(6)(ii) and (iii)).
3. Your Dolo Neuro Xtra Forte (30 and 60 capsule labels) and Super B Complex Stress Relief products are misbranded with the meaning of section 403(a)(1) and 201(n) of the Act [21 U.S.C. §§ 343(a)(1) and 321(n)] in that the products contain added iron for use as an iron source, but the labeling of the products fails to bear the following warning statement as required by 21 CFR 101.17(e): "WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.”
4. Your Leche de Alpiste, Colesstol 200, Colesstol 400, Delgadex, Delgadex Fem, Desin-Flanax XtraForte 850, Dolo Neuro Xtra Forte, Pentrexcilina Citricillin 500, Pharma+Fem, Pharma+Men, SedalFort Migraine, and Super B Complex Stress Relief products are misbranded with the meaning of section 403(f) of the Act [21 U.S.C. § 343(f)] because the product labels contain information in two languages but does not appear to repeat all the required label information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. For example, your Colesstol 200 and Colesstol 400 products do not repeat the required labeling information (e.g., Supplement Facts) in the foreign language.
5. Your Angin Original Formula, Broncolin Plus, Colesstol 200, Colesstol 400, Delgadex, Delgadex Fem, Desin-Flanax XtraForte 850, Pentrexcilina Citricillin 500, Pharma+Fem, Pharma+Men, SedalFort Migraine, Super B Complex Stress Relief, and XXL-6 Fast Relief Effervescent Cold Remedy products are misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event associated with such dietary supplement.
The above violations are not meant to be an all-inclusive list of violations that exist in connection with your products and their labeling. You are responsible for ensuring that all of your products and their labeling comply with the Act and its implementing regulations. You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action without further notice. Such enforcement action may include seizure of illegal products and/or injunctions against manufacturers and distributors of illegal products [21 U.S.C. §§ 334 and 332].
Please notify this office in writing within fifteen (15) working days from your receipt of this letter as to the specific steps you have taken to correct the violations described above and to ensure that similar violations do not occur. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, please explain the reason for your delay and state the date by which the corrections will be completed.
Please send your reply to the attention of Blake Bevill, Director Compliance Branch, Food and Drug Administration, 19701 Fairchild, Irvine, California 92612-2445. If you have any questions regarding any issue in this letter, please contact Blake Bevill at 949-608-4426.
Alonza E. Cruse
Los Angeles District
Cc: Ingeborg Small
Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue - MS 7602
P.O. Box 997413
Sacramento, California 95899-7435
Alex Garcés Cazadero
6225 Progressive Drive, #200
San Diego, California 92154