Inspections, Compliance, Enforcement, and Criminal Investigations

Apis Vida Industria e Comercio Produtos Farmaceuticos Ltda 8/27/15

  

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

Public Health Service
Food and Drug Administration
 College Park, MD  20740 

WARNING LETTER

AUG 27, 2015
 
VIA EXPRESS DELIVERY
 
Mr. Luiz Henrique Matiazzi, President
Apis Vida Industria e Comercio Produtos Farmaceuticos Ltda
Rua Alcidio Pagalelli, 412
Jardim Canada
Bebedouro, Brazil 14707-016
 
Re: 472428
 
Dear Mr. Luiz Henrique Matiazzi:
 
The United States Food and Drug Administration (FDA) inspected your facility, Apis Vida Industria e Comercio Produtos Farmaceuticos Ltda, Bebedouro, Brazil, from March 9-11, 2015. The inspection was conducted to determine your compliance with the Federal Food, Drug, and Cosmetic Act (the Act) and regulations that apply to the food you ship to the United States.
 
We acknowledge your written responses of June 4, July 21, and August 20, 2015, to the Form FDA 483. List of Inspectional Observations that was issued to your firm at the conclusion of our inspection. We reviewed your responses, and have concluded that the corrective actions described appear to be adequate to address the items identified on the FDA 483. The implementation of these corrections may be further evaluated during a subsequent inspection.
 
Based on our review of your product labels collected during the inspection, as well as a subsequent review of your website at beelife.us and your Amazon.com online "store." we have concluded that several of your products are in violation of the Act and the applicable regulations in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You can find copies of the Act and FDA regulations through links in FDA's home page at www.fda.gov .
 
Unapproved New Drugs/Misbranded Drugs
 
Based on our review of your website at beelife.us and your Amazon.com online “store” in June 2015, we have determined that you make claims for the following products that establish that the products are drugs under Section 201(g)(1)(B) of the Act [21 USC § 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease: Green Propolis Extract, Traditional Honey, Organic Honey, Compound Honey, Compound Honey with Propolis and Guaco, Compound Honey with Propolis + Pennyroyal, Compound Honey with Propolis + Watercress, Compound Honey with Propolis + Eucalyptus, Compound Honey with Propolis + Limonium, and Compound Honey with Propolis + Pomegranate. While your products are not available for sale from your beelife.us website, you provide a link from your beelife.us website to your Amazon.com “store,” from which your products can be purchased. 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 observed on your website beelife.us include:
 
Green Propolis Extract
  • “[I]t is an antimicrobial substance and has anti-inflammatory properties…” 
Traditional Honey (tubes: 10.58, 12.35 and 8.82 ounce; pots: 10.58 and17.64 ounce; and sachets: 3.98 lb and 1.41 ounce) and Organic Honey (tubes: 10.58, 12.35 and 8.82 ounce; pots: 10.58 and17.64 ounce; and sachets: 1.41 ounce)
  • “Beelife honey provides strong protection against antibacterial, antioxidant and antifungal action…” 
Compound Honey (with Propolis, with Propolis and Guaco, with Propolis + Pennyroyal, with Propolis + Watercress, with Propolis + Eucalyptus, with Propolis + Limonium, and with Propolis + Pomegranate)
  • “Beelife Compound Honey is used as an aid and relieve of respiratory ailments…”
Compound Honey with Propolis and Guaco
  • “This product combines the properties of honey and propolis with bronchodilator and expectorant action, in additional helps to relieve coughs and other respiratory ailments…”
Compound Honey (with Propolis +Pennyroyal; with Propolis +Watercress; with Propolis + Eucalyptus; with Propolis + Lim onium; and with Pro polis +Pomegranate)
  • "[H]elps to relieve coughs and other respiratory ailments ... " 
From your Amazon.com “store,” to which you provide links from your beelife.us website:
 
Green Propolis Extract
  • “Helps to prevent infections in the respiratory system…it is an antimicrobial substance with healing and anti-inflammatory properties…” 
Compound Honey with Propolis and Guaco - 10.58 Oz
  • “Helps in the treatment and prevention of bronchitis/asthma/coughs and other respiratory ailments…This product combines the properties of honey and propolis with bronchodilator and expectorant action, in additional acts as an adjuvant in cases of bronchitis, asthma, coughs and other respiratory ailments...”
Compound Honey with Propolis and Eucalyptus - 10.58 Oz
  • “Helps to relieve coughs and other respiratory ailments… Is used as an aid in the help of treatment of respiratory ailments…”
Compound Honey with Propolis and Watercress - 10.58 Oz
  • “Helps in the treatment and prevention of bronchitis/asthma/coughs and other respiratory ailments…Honey, Propolis and Watercress form a compound that aids in the treatment of respiratory diseases and coughs…”
Compound Honey with Propolis and Pomegranate - 10.58 Oz
  • “Helps in the treatment and prevention of bronchitis/asthma/coughs and other respiratory ailments…. Helps in the treatment of diseases of the mouth and throat, tonsillitis, laryngitis, hoarseness and dry cough…”
Compound Honey with Propolis and Pennyroyal - 10.58 Oz and Compound Honey with Propolis and Pennyroyal Sachet - 1.41 Oz
  • “Helps in the treatment and prevention of bronchitis/asthma/coughs and other respiratory ailments…With all the properties of Honey, Propolis and Pennyroyal has a great result in aid of respiratory diseases.” 
Your above-listed 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)(1) of the Act [21 USC § 321(p)(1)].  A new drug may not be legally marketed in the United States without prior approval from FDA as described in Section 505(a) of the Act [21 USC § 355(a)].  FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate 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 C.F.R. § 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 Green Propolis Extract, Compound Honey, Compound Honey with Propolis and Guaco, Compound Honey with Propolis + Pennyroyal, Compound Honey with Propolis + Watercress, Compound Honey with Propolis + Eucalyptus, Compound Honey with Propolis + Limonium, and Compound Honey with Propolis + Pomegranate products are intended for prevention or treatment of one or more diseases that are not amenable to self-diagnosis and treatment.  Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, your Green Propolis Extract, Compound Honey, Compound Honey with Propolis and Guaco, Compound Honey with Propolis + Pennyroyal, Compound Honey with Propolis + Watercress, Compound Honey with Propolis + Eucalyptus, Compound Honey with Propolis + Limonium, and Compound Honey with Propolis + Pomegranate 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)).
 
Misbranded Dietary Supplements 
 
Your Amazonia Power Energy Drink dietary supplement product is misbranded under section 403 of the Act [21 U.S.C. § 343] because it does not comply with FDA's labeling regulations under 21 CFR 101. Even if your Green Pro polis Extract product did not have disease claims, which make this product a drug, it would also be misbranded for the same reason: 
  1. Your Green Propolis Extract product is misbranded within the meaning of section 403(q)(5)(F) of the Act (21 U.S.C. 343 (q)(5)(F)) in that the label fails to include a presentation of the nutrition information on the label of your product which complies with 21 CFR 101.36. 
  1. Your product Green Propolis Extract is misbranded within the meaning of section 403(i)(2) of the Act in that the product label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Specifically, you do not list the common or usual name for the ingredient, “Alcohol of cereal.”
  1. Your Amazonia Power Energy Drink product is misbranded within the meaning of Section 403(q)(5)(F)(i) because the label fails to list the servings per container under the serving size on the left hand side of the nutrition label or fails to include this information as part of the net quantity of contents declaration in accordance with 21 CFR 101.36(b)(1)(ii). Your label states “1” to the right of the required heading of “Amount Per Serving” but it is unclear what this “1” is intended to mean. 
  1. Your Amazonia Power Energy Drink product is misbranded within the meaning of section 403(q)(2)(B) of the Act [21 U.S.C 343(q)(2)(B)] in that this product declares nutrients which can be declared as zero, contrary to the requirements of 21 CFR 101.36(b)(2)(i). For example, the Supplement Facts panel declares Total Fat, Riboflavin, Vitamin B3, Vitamin B6, Vitamin B12, and Pantothenic acid as zero. 
  1. Your Amazonia Power Energy Drink product label is misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a US address or US phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.
Misbranded Conventional Foods
 
Your Honey (sachet) and Honey (Net WT 8.82 Oz) products are misbranded under section 403 of the Act [21 U.S.C. § 343] because they do not comply with FDA's labeling regulations under 21 CFR 101. Even if your Compound of Honey with Propolis and Eucalyptus product did not have disease claims, which make this product a drug, it would also be misbranded for the same reason:
 
1.    Your Honey (sachet) Honey (Net WT 8.82 Oz) and Compound of Honey with Propolis and Eucalyptus 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. For example:
  • The serving size for your Honey (sachet) is not based on an appropriate “reference amount customarily consumed” (RACC) that is appropriate to the food as defined within 21 CFR 101.12. The reference amount for honey under 21 CFR 101.12(b) is “1 tbsp” but the label incorrectly bases the Nutritiona Facts information on 1 ½ tbsp. (or 5 sachets) of products. Under 21 CFR 101.9(b)(2)(i)(A), if a unit weighs 50 percent or less of the reference amount, the serving size shall be the number of whole units that most closely approximates the reference amount for the product category. In other words, the serving size for the honey sachets must be based on the number of sachets that most closely approximates 1 tbsp, not 1 1.2 tbsp. Therefore, all of the nutrition amounts of this product are based on the incorrect serving size, including the servings per container.
  • The serving size for your Honey (Net WT 8.82 Oz) is not based on an appropriate “reference amount customarily consumed” (RACC) that is appropriate to the food as defined within 21 CFR 101.12, Table B. The serving size for honey is 1 tablespoon. However, your product label shows a serving size of 1 ½ tablespoons. All of the nutrition amounts of this product are based on the incorrect serving size, including the servings per container.
  • The Servings Per Container for your Compound of Honey with Propolis and Eucalyptus and Honey (Net WT 8.82 Oz) is not stated correctly to meet the requirements of 21 CFR 101.9(b)(8)(i). Multiplying the serving size times the number of servings per container yields an amount less or greater than the net quantity of contents. As such, the Servings Per Container are to be rounded to the nearest whole number, unless the servings per container are between 2 and 5, and the rounding is indicated by use of the term “about” (for example, “about 14 servings”).
The violations cited in this letter are not intended to be an all-inclusive statement of violations 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 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 and injunction. Additionally, we may take further action to refuse admission of your imported products under Section 801(a) of the Act [21 U.S.C. § 381(a)], including placing them on detention without physical examination (DWPE). FDA’s DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry.  DWPE information may be conveyed in FDA’s Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with nutritional labeling and basic labeling requirements are 99-20 and 99-39, respectively. You may view these alerts at: http://www.accessdata.fda.gov/cms_ia/ialist.html.
 
We also offer the following comment regarding the labeling of your dietary supplement products: 
  • Your Brazilian Guarana in capsules and Green Propolis Extract products fail to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. Specifically, the label fails to include the zip code of the distributor’s location.
We also have the following comments regarding your conventional foods:
  • On your Compound of Honey with Propolis and Eucalyptus product, the information panel is not located immediately contiguous and to the right of the principal display panel as required by 21 CPR 101.2(a).
  • You have misspelled the abbreviation for tablespoon in the Nutrition Facts panel for your Compound of Honey with Propolis and Eucalyptus and Honey (Sachet) (spelling as “Tbps”, transposing the “p” and “s”).   
  • We also note that the Honey (sachet) uses a comma in the net quantity of content statement (0,14 Oz). This should be a period.
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 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.
 
You should direct your written reply to: Tyra Wisecup, Compliance Officer, Division of Enforcement (HFS-608), Office of Compliance, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD 20740. If you have any questions regarding this letter you may contact Ms. Wisecup via email at tyra.wisecup@fda.hhs.gov.
 
Sincerely,
/S/
William A. Correll, Jr.
Director
Office of Compliance
Center for Food Safety
      and Applied Nutrition

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