Inspections, Compliance, Enforcement, and Criminal Investigations
Lifeway Foods, Inc. 09-Aug-05
Department of Health and Human Services
Public Health Service
RETURN RECEIPT REQUESTED
August 9, 2005
Julie Smofyansky, President and CEO
Lifeway Foods, Inc.
6431 Oakton Street
Morton Grove, IL 60053
Dear Ms. Smolyansky:
Inspections of your manufacturing plant, L.F.I. Enterprises, !nc. located at 5201 Harbison Avenue, Philadelphia, PA conducted by the Food and Drug Administration (FDA) between December 6, 2004 through December 10, 2004 and April 11 through April 14, 2005, revealed that your products are misbranded within the meaning of Sections 403(g) [21 U.S.C. 343(g)], 403(e) [21 U.S.C. 343(e)], 403(i) [21 U.S.C. 343(i)], and 403(r) [21 U.S.C. 343(r)] of the Federal, Food, Drug and Cosmetic Act (the Act) and Title 21 Code of Federal Regulations (CFR) Part 101, as follows:
1. The products identified as Plain Whipped, Vegetable, Strawberry, Lox and Onion, and Lox and Chives varieties, and Sea Specialties Cream Cheese & Lots of Lox, manufactured for Sea Specialties Incorporated, Miami, Florida, are misbranded under Section 403(g)(1) [21 U.S.C.343(g)(1)] of the Act. These products purport to be or are represented as cream cheese or cream cheese with other foods, for which definitions and standards of identity have been prescribed in 21 CFR 133.133 and 133.134. Based on the recipe you provided the investigator, the products do not conform to the definitions and standards in that they contain the ingredient sour cream, which is not permitted by the standards.
2. The products identified as Ilya's Farm Cream Cheese Spread, Lite Plain Whipped and Lite Chives are misbranded under Section 403(r)(1)(A) [21 U.S.C. 343(r)(1 )(A)] of the Act because the labels bear the nutrient content claim "Lite," but the product labels fail to include the additional information that is required to accompany a "Iite" claim. Specifically, the labels do not identify a reference food as required by 21 CFR 101.13 Q)(1)(ii)(A) and 21 CFR 101.13(j)(2)(i). Additionally, these labels fail to contain the percentage or fraction by which the food has been modified and the amount of the nutrient, that is the subject of the claim, that is in the labeled food and in the reference food, as required by 21 CFR 101.56(bx3)(i}(iii). You are reminded that in order to use a "Light" or "Lite", claim on a food label, the product must meet the nutrient content requirements of 21 CFR 101.56.
3. Your Lifeway brand Gourmet varieties of Plain 'Whipped, Strawberry, Vegetable, Lox and Onion, Lox and Chives; Sea Specialties, Cream Cheese Lots of Lox; and Ilya's brand Cream "Cheese Spread varieties of Lite Plain Whipped, Lite Chives, and Smoked Salmon are misbranded under section 403(i)(2) [21 U.S.C 343(i)(2)] of the Act in that they are fabricated from two or more ingredients, but the labels fail to bear a complete list of all of the ingredients by common or usual name in descending order of predominance by weight, as required by 21 CFR 101.4(a)(1).
For example, the Lifeway Gourmet Cream Cheese Strawberry contains the ingredients sour cream, strawberry jam and strawberry sundae topping; however, the ingredient statement does not include the components of each of these ingredients. This requirement may be met by either parenthetically listing the components after the common or usual name of each ingredient or by listing the components without listing the ingredient itself. Under the first alternative, the components must be listed in descending order of predominance in the ingredient; and under the second alternative, the components must be listed in descending order of predominance in the finished food.
In addition, the ingredients in "Ground Nova Salmon" purchased from [redacted] which is used to manufacture Lifeway brand Gourmet "Cream Cheese Lox" and "Cream Cheese Lox and Onion," are not listed in the ingredient statement. This omission is of particular concern because the "Ground Nova Salmon" includes salmon, which is a known allergen. For some sensitive individuals, the presence of this allergen poses a significant health risk.
We also note that that the locust bean gum and guar gum ingredients must be listed by their common or usual name and not collectively as "vegetable gum."
5. Your Lifeway brand Vegetable, Strawberry, Lox and Onion, Plain Whipped, and Chives cream cheeses are misbranded under Section 403(e)(1) [21 U.S.C 343(e}(1)] of the Act in that the labels fail to bear the name and place of business of the manufacturer, packer or distributor of this product, as required by 21 CFR 101 .5(a).
You should take prompt action to correct these violations. Failure to do so may result in regulatory action without further notice. These actions include, but are not limited to, seizure or injunction. In addition, we may not provide certificates to your firm for export of your products to European Union (EU) countries if you do not correct these
As some additional information, we point out that the standard of identity for cream cheese with other foods provides for nomenclature that must be used to express the statement of identity. The name of the food is "cream cheese with ________," or "cream cheese and _________," with the blank filled in with the name of the foods used in order of predominance by weight (e .g., "Cream Cheese with Lox and Onions," "Cream Cheese with Lox," "Cream Cheese and Lox," etc.) [21 CFR 133.134(c)].
Further, the investigator inspected your firm to determine your compliance with FDA's Seafood Hazard Analysis Critical Control Point (HACCP) Regulations (21 CFR 123), Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products," and the Current Good Manufacturing Practices (CGMP) requirements for foods (21 CFR 110). Your ready to eat (RTE) seafood products, i.e., Ilya's Farm brand of Smoked Salmon Spreadable Cream Cheese, Lifeway Products with Lox, and Sea Specialties brand of Cream Cheese & Lots of Lox, are subject to the HACCP regulations. The Seafood HACCP Regulations were issued pursuant to Section 402(a)(4) [21 U.S.C 342(a)(4)] of the Act. Seafood that is processed in violation of the HACCP regulations is adulterated, according to the Act, because it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or may have been rendered injurious to health. You can find the Act and the Seafood HACCP Regulations through the links on FDA's homepage at http://www.fda.gov.
The seafood HACCP regulations, which became effective on December 18, 1997, require that you implement a preventive system of food safety controls known as HACCP (defined above). HACCP essentially involves:
1) identifying each food safety hazard that, in the absence of controls, is reasonably likely to occur in your products; and
(2) having controls at each "critical -control point" in the processing operation to eliminate or minimize the likelihood that the identified hazard will occur. Prudent processors already take these kinds of measures. HACCP provides a systematic way of identifying, implementing, and documenting those measures that demonstrates to us, to your customers, and to consumers, that you are routinely practicing food safety by design. Seafood processors that have been fully operating HACCP systems advise us that they benefit from it in several ways, including having a more safety oriented workforce, having less product waste and having fewer problems generally.
During our inspection, the investigator provided you with the form FDA-483, which presents his evaluation of your firm's performance regarding various aspects of the HACCP and CGMP requirements. Upon further review, we found the following deviations from the principles of HACCP and the significant requirements of the program as follows:
(1) You must conduct a hazard analysis to determine whether ,there are food safety, hazards that are reasonsably likely to occur and you must have a written plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6 (a) and (b). However, your firm does not have a HACCP plan for your ready to eat (RTE) seafood products, i .e., Ilya's Farm brand of Smoked Salmon Spreadable Cream Cheese and Sea Specialties brand of Cream Cheese & Lots of Lox, to control the potential food safety hazards of pathogens.
(2) You must have sanitation control records that document monitoring and corrections, to comply with 21 CFR 123.11(b). However, your firm did not maintain sanitation control records of:
(a) Safety of the water that comes into contact with food or food contact surfaces or that is used in the manufacture of ice;
(b) Condition and cleanliness of food contact surfaces, including utensils, gloves, and outer garments;
(c) Prevention of cross contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils gloves, and outer garments, and from raw product to processed product;
(d) Maintenance of hand washing, hand sanitizing, and toilet facilities;
(e) Protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical and biological contaminants;
(f) Proper labeling, storage, and use of toxic compounds:
(g) Control of employee health conditions that could result in the microbiological contamination of food, food packaging materials, and food contact surfaces; and
(h) Exclusion of pests from the food plant
We encourage you to make the necessary improvements as soon as possible. However, if you disagree with our preliminary assessment of deviations from the Seafood HACCP regulations, you should explain how your system identifies hazards and implements controls in a manner that the agency should regard as complying with the regulations. We understand that HACCP systems may, be uniquely tailored to meet the circumstances of the individual processor and that there may be more than one effective way to control a particular hazard.
The FDA has also determined that your facility is subject to the registration requirement in 415 of the Act [21 U.S.C. 350d] and FDA's implementing regulation at 21 CFR Part 1, Subpart H. During our inspection at your facility in December 2004, you were advised of this requirement. Our records indicate that, to date, your facility has not been registered with FDA. The failure to register a facility as required is a prohibited act under 301 of the Act [21 U.S.C. 331].
We request that the owner, operator, or agent in charge of this facility, or an individual authorized by this facility's owner, operator, oragent in charge, register the facility with FDA within 30 working days of the date of this letter. Registration may be accomplished on-line at http://www.access.fda.gov. We strongly encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number.
Alternatively, the owner, operator or agent in charge of this facility, or an individual authorized by the facility's owner, operator, oragent in charge, may register the facility by mail or fax (e.g ., if you do not have reasonable access to the Internet) using FDA's food facility registration form, Form 3537. This form may be obtained by calling the FDA industry Systems Help Desk at 1-800-216-7331 or 301-575-0156, or by writing to the agency at the following address:
U.S. Food and Drug Administration, HFS-681
5600 Fishers Lane
Rockville, MD 2085
When completed, the form may be faxed to (301) 210-0247 or mailed to the address above. FDA will process registrations submitted by mail or fax and provide a facility's registration number using the same method used to submit the registration to FDA.
This letter may not list all the deviations at your facility and on your product labels. You are responsible for ensuring that your processing plant operates in compliance with the Federal Food, Drug and Cosmetic Act and the Good Manufacturing Practice regulations (21 CFR Part 110). You are also responsible for ensuring that all of your products are labeled in compliance with sthe laws and regulations enforced by FDA. Additional information, including the Act and Title 21 of the CFR, may be obtained through links at www.fda.gov. In addition, you may find it useful to visit our website at http://www.cfsan.fda.gov when reviewing your label.
Please notify this office in writing within fifteen (15) working days from your receipt of this letter of the specific things that you are doing to correct these deviations. You may wish to include in your response documentation that would be useful in assisting us in evaluating your corrections. 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. Copies of the revised labels should also be submitted.
Your response should be sent to Lynn S. Bonner, Compliance Officer at the address noted above.
Thomas D. Gardine