Inspections, Compliance, Enforcement, and Criminal Investigations
Rol-rom Foods 6/28/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Telephone (973) 331-4908
June 28, 2012
VIA UPS OVERNIGHT
Mr. Rolando Romeo
33 Sixth Ave.
Paterson, NJ 07524
File No. 12-NWJ-18
Dear Mr. Romeo:
An inspection of your facility located at 33 Sixth Ave, Paterson, NJ 07524 was conducted by an investigator from the US Food and Drug Administration on February 15 and 21, 2012. During this inspection, a sample of your product, Puro Segura Lemon Juice, 1 QT., was collected. A review of this product label revealed significant violations of the food standards and labeling regulations for foods, Title 21, Code of Federal Regulations, Parts 146 and 101 (21 CFR 146 and 101. These violations cause your product, Puro Segura Lemon Juice, to be misbranded within the meaning of section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343]. You may find the Act and its implementing regulations through links on FDA's home page at www.fda.gov.
Your Puro Segura Lemon Juice product is misbranded within the meaning of section 403(g)(1) of the Act [21 U.S.C. § 343(g)(1)] in that it purports to be and is represented as a food for which a definition and standard of identity has been prescribed by regulation but it fails to conform to such definitions and standards. Based on your label, your product contains citric acid, which is not permitted by the standard for lemon juice (21 CFR 146.114).
In addition, the standard for lemon juice requires that, if the product is made from lemon concentrate, the name of the food is "lemon juice from concentrate" or "reconstituted lemon juice" [21 CFR 146.114(b)]. The words ''from concentrate" or "reconstituted" shall be shown in letters not less than one-half the height of the letters in the word "lemon juice." Based on your label, your product is made from lemon juice concentrate. Therefore, if your product met the standard for lemon juice, your product name ("lemon juice") would not be correct because it fails to indicate that the product is from concentrate or reconstituted.
Your Puro Seguro Lemon Juice product is also misbranded within the meaning of section 403(1)(2) of the Act [21 U.S.C. § 343(i)(2)] because it purports to be a beverage containing fruit juice, but the label fails to bear a percentage declared by the words "Contains_ percent (or %)_ juice" or a similar phrase with the first blank filled in with the percentage of the juice and the second blank (if used) filled in with the name of the particular fruit or vegetable (e.g., "Contains 50 percent apple juice" or "50 percent juice") juice as required by 21 CFR 101.30(b)(1).
The above violations concern certain labeling requirements and are not meant to be an all-inclusive list of deficiencies on your labels. Other label violations can subject the food to legal action. It is your responsibility to assure that all of your products are labeled in compliance with all applicable statutes enforced by FDA.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility. 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 assure 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.
We have the following labeling comments:
1. We also note that your product label declares "natural flavors" as an ingredient. Lemon oil and lemon essence (derived from lemons) may be adjusted within good manufacturing practice under 21 CFR 146.114; however, any other type of added flavor is not permitted. Lemon oil and lemon essence (derived from lemons) added for adjustment do not have to be declared as "ingredients" unless they are added at levels significantly in excess of those found in the raw lemon juice.
2. We also note that your Puro Seguro Lemon Juice label declares the ingredients sodium benzoate and potassium sorbate but fails to provide descriptions of their function as required by 21 CFR 101.22(j).
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.
Your response should be addressed to U.S. Food and. Drug Administration, 10 Waterview Boulevard, 3rd Floor, Parsippany, New Jersey, 07054, Attn: Kerry Kurdilla, Compliance Officer.
New Jersey District