Department of Health and Human Services' logo Department of Health and Human Services

Public Health Service
Food and Drug Administration
Chicago District

 

550 W Jackson Blvd, 15th Fl
Chicago, IL 60661
Telephone: 312-353-5863

July 13, 2006
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

Boris Grinberg, President
Grinalat Foods Corp
2486 E. Oakton St
Arlington Heights, IL 60005-4820

Ref. No. CHI-2-06

Dear Mr Grinberg:

The Food and Drug Administration (FDA) inspected your firm on March 9, 16, and 28, 2006. During the inspection, labels of several of your firm's products were collected or photographed for further review: Hyson Premium Green Tea; Hyson Black Currant Premium Ceylon Tea; Hyson English Breakfast Premium Ceylon Tea; and Hyson Wildflower Honey. Our review shows serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) in the labeling of these products. You can find the Act and implementing regulations through links in FDA's Internet home page at www.fda.gov.

Under the Act, articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man are drugs [Section 201(g)(1)(B) of the Act, 21 USC 321 (g)(1)(B)]. According to your products' labeling, the products listed above are intended to prevent, treat, or cure a variety of diseases, including serious diseases like cancer and cardiovascular disease. Specifically, the labeling for your products bears the following claims:

Hyson Premium Green Tea
  • "Lower risk of heart Ailments"
  • "Tones down blood pressure and cholesterol levels"
  • "[P]revents blood clotting"
  • "[R]educes risk of cancer"
  • "[P]revents tooth decay"
Hyson Black Currant Ceylon Tea
  • "Lower risk of heart Ailments"
  • "Tones down blood pressure and cholesterol levels"
  • "[P]revents blood clotting"
  • "[R]educes risk of cancer"
  • "[P]revents tooth decay"
Hyson English Breakfast Premium Ceylon Tea
  • "Lower risk of heart Ailments"
  • "Tones down blood pressure and cholesterol levels"
  • "[P]revents blood clotting"
  • "[R]educes risk of cancer"
  • "[P]revents tooth decay"
Hyson Wildflower Honey [identified on the label as a "Product of Lithuania"]
  • "Honey from Lithuania is rich in … antibacterial components, … and helps to prevent high blood pressure. It is [sic] perfect natural healer for all kinds of inflammations, cold.…"

These claims cause your products to be drugs, as defined in Section 201(g)(1)(B) of the Act [21 USC 321(g)(1)(B)]. Because these products are not generally recognized as safe and effective when used as labeled, they are also new drugs as defined in Section 201(p) of the Act [21 USC 321(p)]. Under Section 505 of the Act (21 USC 355), anew drug may not be legally marketed in the United States without an approved New Drug Application (NDA). 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. Your products are also misbranded within the meaning of Section 502(f)(1) of the Act, in that the labeling for these drugs fails to bear adequate directions for use [21 USC 352(f)(1)].

The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations.

Failure to promptly correct these violations may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.

In addition to the violations described above, FDA has the following comments concerning the labeling of your products.

Your Hyson Wildflower Honey product is labeled "rich in vitamins," but we note that no vitamins are declared in the nutrition facts table on the product label. If the reason for not declaring any vitamins in the nutrition facts table is that Hyson Wildflower Honey does not contain any vitamins in more than insignificant amounts [see Title 21, Code of Federal Regulations (CFR), 101.9(f)(1)-(f)(3)], this product does not qualify to bear the claim "rich in vitamins." Products that bear the nutrient content claim "rich" must contain 20% or more of the Daily Value (DV) of the nutrient referred to in the claim per reference amount customarily consumed (RACC) [21 CFR 101.54(b)]. The Daily Values for vitamins, which are called Reference Daily Intakes (RDIs), are listed in 21 CFR 101.9(c)(8)(iv). The RACC for honey is 1 tablespoon [see 21 CFR 101.12(b) Table 2].

We also note that your tea and honey products appear to use a simplified format of the nutrition facts table on the product labels. The simplified format is described in 21 CFR 101.9(f) and may be used when a food product contains an insignificant amount (as defined in 21 CFR 101.9(f)(1)) of eight or more of the nutrients listed in 21 CFR 101.9(f). If your tea and honey products qualify for the simplified format in 21 CFR 101.9(f) and you elect to use that format, you must comply with the content and format requirements in that regulation, including declaring all nutrients that are required to appear in the nutrition facts table [see 21 CFR 101.9(f)(2)]; declaring the quantitative amount of nutrients when required [see 21 CFR 101.9(c), (d)(7) and (f)(5)]; including the statement "Not a significant source of" (with the blank filled in with the names of the nutrients identified in 21 CFR 101.9(f) that are present in insignificant amounts, and calories from fat, if present in an insignificant amount) at the bottom of the nutrition label [see 21 CFR 101.9(f)(4)]; and following all requirements for placement and separation of the elements of the nutrition facts table (e.g., including the "% Daily Value" column heading and separating the calorie information from the "% Daily Value" heading and nutrient information below with a bar.) We recommend that you review all your product labels to make sure they are in compliance with the content and format requirements for nutrition information.

You must immediately correct these violations. If you do not immediately correct them, you may be subject to enforcement action without further notice. The Act provides for seizure of illegal products and for injunctions against the manufacturers and distributors of illegal products [21 USC 332 and 334]. Individuals and businesses that violate the Act may also be subject to criminal prosecution.

Please advise this office in writing, within 15 working days of receipt of this letter, as to the specific steps you have taken or will be taking to correct these violations, including the steps taken to assure that similar violations do not recur. Include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.

Your reply should be addressed to Compliance Officer Patrick J. Brown, at the above address.

Sincerely,
/s/
Scott J. MacIntire
District Director

This page was posted on February 12, 2008.

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