Source: https://www.casewatch.net/fdawarning/prod/2007/novis.shtml
Timestamp: 2019-07-15 18:43:57
Document Index: 252862787

Matched Legal Cases: ['§ 341', '§ 341', '§ 341', '§ 341', '§ 341', '§ 341', '§ 341', '§ 341', '§ 341', '§ 341', '§ 341', '§ 341', '§ 352', '§ 330', 'art 341', 'art 341', '§ 341', '§ 341', '§ 341', '§ 352', '§ 211', '§ 211', '§ 352', '§ 343', '§ 321', '§ 101', '§ 343', '§ 343', '§ 101', '§ 343', '§ 101', '§ 101', '§ 101', '§ 343', '§ 101', '§ 101']

This Warning Letter is in reference to the inspection of your facility, located at 112 Mayaguez Street, San Juan, Puerto Rico 00918, from November 30, 2006, to December 22, 2006, by an investigator from the U.S. Food and Drug Administration's San Juan District Office.
The product's carton labeling bears directions for use for infants from age 1 month to 2 years of age. Under the regulations on OTC cough/cold drug products, directions for use on the consumer labeling are not permitted for children under 2 years of age for antitussive drug products (21 C.F.R. § 341.74(d)(I)(ii)), for expectorant drug products (21 C.F.R. § 341.78(d)), and for nasal decongestant drug products (21 C.F.R. § 341.80(d)(1)(1)).
• 21 C.F.R. § 341.74(c)(1) and 21 C.F.R. § 341.78(c)(I) - "A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor."
• 21 C.F.R. § 341.74(c)(3) and 21 C.F.R. § 341.78(c)(3) - "Do not give this product for persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor."
• 21 C.F.R. § 341.74(c)(4)(v) and 21 C.F.R. § 341.80(c)(1)(i)(D) - "Do not use in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product."
21 C.F.R. § 341.80(c)(1)(ii)(A) - "Do not exceed recommended dosage. [first sentence in boldface type] If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor."
• 21 C.F.R. § 341.80(c)(1)(ii)(B) -"If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor."
• 21 CFR § 341.80(c)(1)(ii)(C) -"Do not give this product to a child who has heart disease, high blood pressure, thyroid disease, or diabetes unless directed by a doctor."
Tussi-Pres Pediatric Liquid: The product contains the combination of [redacted] and [redacted] and is offered as an expectorant, antitussive, and nasal decongestant. The product is misbranded under section 502(f)(2) of the Act (21 U.S.C. § 352(f)(2)) because it fails to bear the "overdose" warning required under 21 C.F.R. § 330.1(g). The Tussi-Pres Pediatric Liquid is subject to the final regulations covering OTC cough/cold preparations at 21 C.F.R. Part 341. The product is labeled as a "pediatric° preparation, but the directions for use section includes dosing instructions for "children 12 and over." Under the final regulations at 21 C.F.R. Part 341, products that are
labeled for children 12 years and older must bear certain warnings that are not required if the product is labeled only for children under 12 years of age. The product does not bear the"smoking" or "emphysema" or "chronic bronchitis" portions of the warnings required under 21 C.F.R. § 341.74(c)(2) and 21 C.F.R. § 341.78(c)(2), or the "difficulty in urination due to enlargement of the prostate gland" portion of the warning required under 21 C.F.R. § 341.80(ci(1)(C). Tussi-Pres- Pediatric is therefore misbranded under section 502(f)(2) of the Act (21 U.S.C. § 352(f)(2)) because if fails to bear the warnings listed above.
Tamper-Evident Packaging Statements: The tamper-evident packaging (TEP) statements on the Dologen caplets ("safety seal under cap ..."), Bicarsim and Bicarsim Forte tablets ("do not use if seal around cap . . ."), Tussi-Pres Liquid ("do not use if cap seal . . ."), and Tussi-Pres Pediatric Liquid ("heat seal under cap . . ."), which specify these products' TEP features; fail to reference the identifying characteristic of the TEP features (21 C.F.R. § 211.132(b)) as required by 21 C.F.R. § 211.12(c)(2). Thus, the products are misbranded under section 502(a) of the Act(21 U.S.C. § 352(a)). .
Disease claims in the product's label and labeling (promotional material) include: Label - "Helps in treatment of abnormal capillary permeability".
Labeling -"For prevention & treatment of abnormal capillary permeability fragility & capillary bleeding. As an aid in the palliative treatment of varicose veins".
Label -"Clinically proven to relieve venous circulatory disorders such as tired legs, heaviness in the legs, swelling or pain".
Labeling -"For the symptomatic relief of venous insufficiency including swelling of the legs (edema), pain in the extremities (dull aching, heaviness or cramping), varicose veins and itching".
Label -°°INDICATIONS: For the treatment of capillary permeability, chronic venous insufficiency and hemorrhoidal disease".
-Labeling - "For the treatment of hemorrhoidal disease, capillary permeability and chronic
venous insufficiency".
Labeling - "Indications . . . chronic diseases . . . debilitated, alcoholics . . . stressed by
infections, burns"
Label - states "[I]mmuno-competence to aid in the prevention of cancer . . .
Your Apetigen-Plus - A palatable mixture of B-Complex vitamins with Zinc, Iron, and Lysine (1 and 8 fl. oz.), Lysiplex Plus Tables - Appetite Stimulant Formula with Iron, Zinc, B-Complex, Folic Acid and Branch Chain Amino Acids (BCAAs) (90 tablets), Lysiplex Plus - Appetite Stimulant Formula with Iron & Zinc (1, 6, 16 fl. oz.), and Lysiplex Plus - Appetite Stimulant Formula with Iron, Zinc & B-Complex (6, 16 fl. oz.) products are misbranded within the meaning of sections 403(a)(1) and 201(n) of the Act (21 U.S.C. § 343(a)(1) and 21 U.S.C. § 321(n)) because the labels for these products, which contain added iron, fail to bear the following warning statement as required by 21 CFR § 101.17(e):
Your Lysiplex product is misbranded within the meaning of section 403(a)(1) of the Act (21 U.S.C § 343(a)(1)) because the label bears the "Rx" symbol and the National Drug Code (NDC) numbers. The use of this symbol and NDC numbers are false and misleading in that it represents the product as a prescription drug when, in fact, it is not because your product is also labeled as a dietary supplement.
Your Calcibon, Apetigen-Plus Fortified with Zinc, Dietex Forte, Pre-Protein Tablets (6 tablets and 90 tablets count), and Vasoflex HD (90 caplets) products are misbranded within the meaning of sections 1403(i)(1) and 403(s) (2) (B) of the Act (21 U.S.C. §§ 343(i)(1),343(s)(2)(B)). Although some of these products are identified as a dietary supplement in the information panel on the product label, the labels fail to identify the products using the term "dietary supplement," or a similar term- describing the type of supplement (e.g., "herbal supplement") as part of the statement of identity on the principal display panel, as required under 21 CFR §§ 101.3(d) and (g).
Further, your products Apetigen-Plus Fortified with Zinc (60 tablets), Lysiplex Plus Appetite Stimulant Formula with Iron, Zinc, & B-Complex, Lysiplex Plus Tablets Appetite Stimulant Formula with Iron, Zinc, B-Complex, Folic Acid and BCAAs an d Pre-Protein Liquid Predigested Protein 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 labels fail to bear nutrition labeling in "Supplement Facts" format as required under 21 CFR § 101.36. The following are examples:
• The labels for your product Apetigen-Plus Fortified with Zinc (60 tablets ) and Lysiplex Plus Appetite Stimulant Formula with Iron, Zinc, & B-Complex do not have the title, "Supplement Facts," and Apetigen-Plus Fortified with Zinc does not enclose the nutrition information using hairlines as required by 21 CFR §§ 101.36(e)(1) and (e)(2), respectively.
• The label for your product Pre-Protein Liquid Predigested Protein lists individual amino acids as part of the 15 grams of protein provided as indicated on your "Supplements Facts" panel. However, these dietary ingredients, for which FDA has not established RDIs or DRVs, must be listed within the nutrition labeling ("Supplement Facts") as required by 21 CFR § 101.36(b)(3).
The label for your products Apetigen - A palatable mixture of B-Complex vitamins with Lysine, and Lysiplex Plus Tablets - Appetite Stimulant Formula with Iron, Zinc, B-Complex, Folic Acid and BCAAs are misbranded within the meaning section 403(r)(1)(A) of the Act (21 U.S.C. § 343(r)(1)(A)) because the labels make the unauthorized nutrient content claims "A palatable mixture . . . with Lysine" and "Appetite Stimulant Formula . . . with BCAA's." For your information, Lysine and BCCAs are dietary ingredients that do no have established RDI (21 CFR § 101.9(c)(8)(iv)) or DRV (21 CFR § 101.9(c)(9)). Therefore, these claims are not authorized for substances without a DRV or RDI. FDA considers "with" to be synonymous with "contains" in the context used on these labels.
You have been previously advised that your products do not comply with applicable requirements in the Act and its implementing regulations. On May 11, 2005, a Regulatory Meeting was held at the FDA San Juan District Office. At that meeting, you were advised of your firm's deviations from the requirements for dietary supplements and OTC drug products.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the referenced 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 you will complete the correction. Your reply should be directed to: the Food and Drug Administration, attention: Carlos A. Medina, Compliance Officer, at 466 Fernandez Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions regarding any issue in this letter, please contact Mr . Medina at (787) 474-9538, carlosa.medina@fda.hhs.gov. You can also find the Act, regulations, and guidelines through links in FDA's Internet homepage at http://www.fda.gov.