Inspections, Compliance, Enforcement, and Criminal Investigations
Glenn Foods, Inc. 26-Nov-07
Department of Health and Human Services
Public Health Service
Nov 26 2007
RETURN RECEIPT REQUESTED
Glenn Foods, Inc.
191 Hanse Avenue
Freeport, New York 11520
Dear Mr. Schacher:
The Food and Drug Administration (FDA) has reviewed the label of your Glenny's® Low Fat Soy Crisps (cheddar cheese flavor). FDA's review found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and Title 21, Code of Federal Regulations (21 CFR). You can find the Act and FDA's regulations through links on FDA's Internet homepage at http://www.fda.gov.
Your Glenny's® Low Fat Soy Crisps (cheddar cheese flavor) product is adulterated under section 402(a)(2)(C) of the Act [21 U.S.C. 342(a)(2)(C)] because it contains a food additive, namely folic acid, which is unsafe within the meaning of section 409 of the Act (21 U.S.C. 348).
Any substance intentionally added to a conventional food such as soy crisps must be used in accordance with a food additive regulation approving the substance for that use, unless the substance is generally recognized as safe (GRAS) among experts qualified by scientific training and experience to evaluate its safety under the conditions of intended use, or is otherwise exempt from the food additive definition in section 201(s) of the Act [21 U.S.C. 321(s)].
The food additive regulation for folic acid (21 CFR 172 .345) does not provide for the addition of folic acid to snack products, such as your soy crisp products. The restrictions on foods to which folic acid can be lawfully added were established under FDA's authority to prescribe conditions for the safe use of food additives [see section 409(a) and (c) of the Act]. They are designed to keep total daily folic acid intake to 1 milligram or less for important public health reasons [see 21 CFR 172.345 ; 61 Federal Register 8797 (March 5, 1996)]. Because consumption of higher levels of folic acid can mask anemia in persons with vitamin B 12 deficiency, consequences of the anemia (i.e., severe and irreversible neurological damage) could go undetected in such persons if the restrictions in the food additive regulation for folic acid are not followed.
Additionally, your Glenny's® Low Fat Soy Crisps® product is misbranded under section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)] because its labeling is false. The product's principal display panel declares "REAL CHEDDAR CHEESE" and the information panel declares "With Real Cheddar Cheese!" The graphics on the principal display panel and information panel also depict a block of cheese and cheese slices adjacent to the statements that represent the product as containing this ingredient. Cheddar cheese is a food for which a definition and standard of identity has been prescribed by regulation; however, according to the ingredient statement, the product does not contain any cheddar cheese. Rather, the ingredient statement declares "cheddar cheese powder," which does not meet the definition and standard of identity of cheddar cheese under 21 CFR 133.113.
Your soy crisp product is also misbranded within the meaning of section 403(q)(1) of the Act [21 U.S.C. 343(q)(1)] because the serving size and nutrition information on the label are not based on the established Reference Amount Customarily Consumed (RACC) for this food. As you may be aware, FDA promulgated regulations under section 403(q) of the Act that require nutrition information to be based on a serving size that is derived from the established RACC for the food. The RACCs are established by regulation in 21 CFR 101.12. The RACC for snack foods such as your Glenny's® Low Fat Soy Crispso is 30 grams (g) (21 CFR 101.12(b), Table 2, "Snacks: All varieties, chips, pretzels. . ."). The 1.3 ounce (37g) package of Glenny's® Low Fat Soy Crisps® is approximately 123 percent of the established 30 gram RACC. Under FDA's regulations, a product that is packaged and sold individually and that contains less than 200 percent of the RACC shall be considered to be a single-serving container, and the entire content of the product shall be labeled as one serving [21 CFR 101.9(b)(6)]. Accordingly, the serving size declared on your individually sold packages of Glenny's® Low Fat Soy Crisps® must be the entire 37g package, and the nutrition information on the label must be based on a 37g serving . Because the nutrition information on your Glenny's Low Fat Soy Crisps® is based on an 18g serving, the per-serving amounts of calories and other nutrients declared are approximately half of what they should be.
Furthermore, your soy crisp product is misbranded within the meaning of section 403(r)(1) and (2) [21 U.S.C. 343(r)(1) and (2)] for failing to meet the requirements for the nutrient content claim and health claims on the product label, as follows:
• Your product label bears the nutrient content claim "low fat," but based on the nutrition information provided on the label, this product does not meet the definition for "low fat" in FDA's regulations [21 CFR 101.62(b)(2)]. The RACC for a snack food is 30g. To qualify for a low fat claim, your snack food must contain 3g or less of total fat per RACC and, in this case, because the RACC is small, per 50g [21 CFR 101.62(b)(2)(i)(B)]. The Nutrition Facts panel states that the product contains 2g of fat per 18g; this is equivalent to 5 .6g of fat per 50g.
• Your product also bears the following health claims on the back of the label:
One 1.3 oz. bag provides you with:
9g Soy Protein
23mg Soy Isoflavones
40% RDI Folic Acid
30% RDI Calcium"
Within the context of this label, the heart symbols, located adjacent to information about the level of protein, isoflavones, folic acid and calcium, under the heading "HEALTHY BENEFITS," constitute implied health claims about consumption of these substances and reduced risk of coronary heart disease [21 CFR 101.14(a)(1)].
1. Although FDA has authorized a health claim for soy protein and reduced risk of coronary heart disease, your product label does not include all of the elements of the claim that are required by the regulation governing the use of this claim [21 CFR 101.82(c)(2)(i)]. Your product also does not qualify for this health claim because the product is not low in fat [21 CFR 101.82(c)(2)(iii)(C)].
2. FDA has not authorized a health claim associating a reduced risk of coronary heart disease with the consumption of soy isoflavones, folic acid, or calcium. Therefore, the use of hearts to highlight the presence of soy protein, soy isoflavones, folic acid, and calcium under the heading "HEALTHY BENEFITS" constitutes unauthorized health claims that are prohibited in food labeling [21 CFR 101.14(e)(1)].
The above violations are not meant to be an all-inclusive list of deficiencies in your products or their labeling. It is your responsibility to ensure that all of your products are in compliance with the laws and regulations enforced by FDA. Failure to do so may result in regulatory action without further notice. These actions include, but are not limited to, seizure and/or injunction.
In addition to the labeling violations mentioned above, we also have several labeling comments concerning your product. For example, we note that the first ingredient declared in your ingredient statement is "Low fat non-GMO soy flour." The claims "low fat" and "non-GMO" are considered intervening material. Under 21 CFR 101.2(e), all required statements on the information panel of a food label must appear in one place without other intervening material. Also, the information following your ingredient statement declares "ALLERGENS: Contains soy. . ." but fails to declare the presence of milk, which is listed as an ingredient in your product and is also a major food allergen under section 201(qq) of the Act [21 U.S.C. 321(qq)]. If a "Contains" statement is used on a food label, the statement must include the names of the food sources of all major food allergens used as ingredients in the packaged food. In addition, your advisory labeling (i.e., "Made in a facility. . .") should not be part of the "ALLERGENS: Contains" statement.
Furthermore, we have the following labeling comments concerning the Nutrition Facts panel:
• The label bears the claim "9g Soy Protein." Therefore, the Nutrition Facts panel must include the percent Daily Value for protein as required by and calculated according to 21 CFR 101.9(c)(7).
• The Nutrition Facts panel on this product is not set off in a box as required by 21 CFR 101.9(d)(1)(i).
Please notify this office in writing, within 15 working days of receipt of this letter, of the specific steps you have taken or plan to take to correct the noted violations and prevent future violations. Include any documentation necessary to show that correction has been achieved. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. Please send your reply to the attention of Lynn Szybist, Compliance Officer, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Compliance, Division of Enforcement, 5100 Paint Branch Parkway (HFS-608), College Park, Maryland 20740. If you have any questions regarding any issue in this letter, please contact Ms. Szybist at (301) 436-2040.
Joseph R. Baca
Office of Compliance
Center for Food Safety
and Applied Nutrition