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U.S. Department of Health and Human Services

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HBB, LLC dba Baked World 7/28/11

  

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

Public Health Service
Food and Drug Administration
 
5100 Paint Branch Parkway
College Park, MD 20740 


 

WARNING LETTER
 
JUL 28, 2011
 
 
Via UPS Overnight Delivery Service
 
 
Terry Harris
HBB, LLC dba Baked World
1837 Harbor Avenue
Memphis, TN 38113
 
Re: 157572
 
 
Dear Mr. Harris:
                                                                                                                       
The Food and Drug Administration (FDA) has reviewed the regulatory status of your product, “Lazy Larry” (formerly “Lazy Cakes”). Your “Lazy Larry” product is adulterated under section 402(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. § 342(a)(2)(C)] because it bears or contains an unsafe food additive. Specifically, it contains melatonin (5-methoxy-N-acetyltryptamine, CAS Reg. No. 73-31-4), which is a neurohormone and is an unapproved food additive under section 409 of the FDCA [21 U.S.C. § 348]. The regulations pertaining to the general provisions for food additives are located in Title 21, Code of Federal Regulations (21 CFR), Part 170. You can find copies of the FDCA and these regulations through links on FDA’s home page at http://www.fda.gov.
 
Your “Lazy Larry” product is represented for use as a conventional food, and accordingly is not a dietary supplement, as defined under Section 201(ff) of the FDCA [21 U.S.C. § 321(ff)]. The FDCA excludes from the definition of a dietary supplement a product represented for use as a conventional food or as a sole item of a meal or the diet [21 U.S.C. § 321(ff)(2)(B)].  Your use of the term “dietary supplement” in the statement of identity and your use of a “Supplement Facts” panel for nutrition labeling do not make your product a dietary supplement, because your “Lazy Larry” product is represented for use as a conventional food. Examples of factors and information that establish that the product is represented as a conventional food are as follows:
 
- the product is marketed alongside snack foods;
- the name of a URL, www.mylazycakes.com (accessed 7-14-11), that directs people to your product website, refers to a conventional food (cake);
- the product is described on your website (accessed 7-14-11) as having “the same ingredients your mother uses to make brownies,” which is a conventional food;
- the use of a combination of ingredients particular to a brownie (including sugar, flour, oil, cocoa, egg, and salt, in order of predominance by weight);
- the appearance and packaging of the product as a brownie.
 
As previously sold, your “Lazy Cakes” product additionally was represented for use as conventional food, for example, by the use of the words “cakes” in the product name and use of the word “brownie” in the statement of identity on the package label.
 
Any substance added to a conventional food, such as your “Lazy Larry” product must be used in accordance with a food additive regulation, unless the substance is the subject of a prior sanction or is generally recognized as safe (GRAS) among qualified experts for its use in foods [21 CFR 170.30(g)]. There is no food additive regulation that authorizes the use of melatonin. We are not aware of any information to indicate that melatonin is the subject of a prior sanction [see 21 CFR Part 181]. As explained below, we are not aware of any basis to conclude that melatonin is GRAS for use in conventional foods. 
 
FDA’s regulations in 21 CFR 170.30(a)-(c) describe criteria for eligibility for classification of a food ingredient as GRAS. General recognition of safety must be based only on the views of qualified experts. The basis of such views may be either (1) scientific procedures or (2) in the case of a substance used in food prior to January 1, 1958, through experience based on common use in food. In addition, general recognition of safety requires common knowledge about the substance throughout the scientific community knowledgeable about the safety of substances directly or indirectly added to food.
  • Under 21 CFR 170.3(h), “[s]cientific procedures include those human, animal, analytical, and other scientific studies, whether published or unpublished, appropriate to establish the safety of a substance.” Under 21 CFR 170.30(b), “[g]eneral recognition of safety based upon scientific procedures shall require the same quantity and quality of scientific evidence as is required to obtain approval of a food additive regulation for the ingredient.” Section 170.30(b) further states that general recognition of safety through scientific procedures is ordinarily based upon published studies, which may be corroborated by unpublished studies and other data and information.
  • Under 21 CFR 170.3(f), “[c]ommon use in food means a substantial history of consumption of a substance for food use by a significant number of consumers.” Under 21 CFR 170.30(c)(1), “[g]eneral recognition of safety through experience based on common use in food prior to January 1, 1958, shall be based solely on food use of the substance prior to January 1, 1958, and shall ordinarily be based upon generally available data and information.” Importantly, however, the fact that a substance was added to food before 1958 does not, in itself, demonstrate that such use is safe, unless the pre-1958 use is sufficient to demonstrate to qualified experts that the substance is safe when added to food [21 CFR 170.30(a)].
  • Under 21 CFR 170.3(i), “[s]afe or safety means that there is a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use.” The regulation provides that, in determining safety, the following factors are to be considered: (1) The probable consumption of the substance and of any substance formed in or on food because of its use; (2) the cumulative effect of the substance in the diet, taking into account any chemically or pharmacologically related substance or substances in such diet; and (3) safety factors which, in the opinion of qualified experts, are generally recognized as appropriate. Such safety factors ordinarily are established through extensive testing in animals to determine whether consumption of the ingredient produces adverse effects when consumed chronically (i.e., on a daily basis over the course of a lifetime).1
We know of no basis for general recognition of safety for melatonin based either on scientific procedures or common use in food prior to January 1, 1958. Melatonin is a neurohormone that is used for medicinal purposes, primarily as a sleep aid in the treatment of sleep-related disorders.  In assessing the GRAS status of melatonin for use in a conventional food such as “Lazy Larry,” we considered the criteria described above. FDA is not aware of data to establish the safety of melatonin for use as an ingredient in conventional foods. On the contrary, reports in the scientific literature have raised safety concerns about the use of melatonin. Among these are concerns about effects on blood glucose homeostasis (References 1- 4), and effects on the reproductive/developmental (References 5- 11), cardiovascular (References 12- 18), ocular (References 19- 21) and neurological systems (References 22, 23). Therefore, the use of melatonin in your “Lazy Larry” product does not satisfy the criteria for GRAS status under 21 CFR 170.30.
 
FDA is not aware of any other exemption from the food additive definition that would apply to melatonin for use as an ingredient in a conventional food, such as your brownie product. Therefore, melatonin added to a conventional food is a food additive under section 201(s) of the FDCA [21 U.S.C § 321(s)] and is subject to the provisions of section 409 of the FDCA [21 U.S.C. § 348]. Under section 409, a food additive is deemed unsafe unless it is approved by FDA for its intended use prior to marketing.  Melatonin is not approved for use in any food, including brownies. Therefore, your “Lazy Larry” product is adulterated within the meaning of section 402(a)(2)(C) of the FDCA [21 U.S.C. § 342(a)(2)(C)].
 
You should take prompt action to correct this violation and prevent its future recurrence. Failure to do so may result in enforcement action without further notice. The FDCA authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products. We want you to be aware that FDA did not conduct an all-inclusive review of your “Lazy Larry” product or other products you manufacture or distribute. It is the responsibility of a manufacturer to ensure that foods the firm markets are safe and otherwise in compliance with all applicable legal and regulatory requirements.
 
Please advise this office in writing within fifteen (15) days from your receipt of this letter as to the specific steps you have taken to correct the violation noted above and to assure that similar violations do not occur in the future. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, please explain the reason for your delay and the date by which each item will be corrected and documented. 
 
Please send your reply to Kathleen M. Lewis, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Compliance (HFS-608), 5100 Paint Branch Parkway, College Park, MD 20740.
 
 
Sincerely,
/S/ 
Michael W Roosevelt
Acting Director
Office of Compliance
Center for Food Safety
and Applied Nutrition
 
 
                                                                                                                                   
cc: New Orleans District Office
 

References:


1. Peschke, E., Schucht, H., and Muhlbauer, E. 2010. Long-term enteral administration of melatonin reduces plasma insulin and increases expression of pineal insulin receptors in both Wistar and type 2-diabetic Goto-Kakizaki rats. J. Pineal Res.; 49: 373-381.
2. Puchalski, S. S., Green, J. N., and Rasmussen, D. D. 2003. Melatonin effects on metabolism independent of gonad function. Endocrine; 21: 169-173.
3. Rasmussen, D. D., Boldt, B. M., Wilkinson, C. W., Yellon, S. M., and Matsumoto, A. M. 1999. Daily melatonin administration at middle age suppresses male rat visceral fat, plasma leptin, and plasma insulin to youthful levels. Endocrinology; 140: 10091012.
4. Cagnacci, A., Arangino, S., Renzi, A., Paoletti, A. M., Melis, G. B., Cagnacci, P., and Volpe, A. 2001. Influence of melatonin administration on glucose tolerance and insulin sensitivity of postmenopausal women. Clin Endocrinol. (Oxt); 54: 339-346.
5. Singh, H. J., Keah, L. S., Kumar, A., and Sirajudeen, K. N. S. 2011. Adverse effects of melatoninon rat pups of Wistar-Kyoto dams receiving melatonin supplementation during pregnancy. Exp. Toxicol. Pathol.; doi:10.1016j.etp.2011.01.011
6. Okatani, Y., Wakatsuki, A., Otukonyong, E. E., and Miyahara, Y. 2001. Effect of prenatal melatonin exposure on gonadotropins and prolactin secretion in male and female rat pups. Eur. J. Pharmacol.; 424: 229-235.
7. Luboshitzky, R., Shen-Orr, Z., Nave, R., Lavi, S., and Lavie, P. 2002. Melatonin administration alters semen quality in healthy men. J. Andrology ; 23: 572-578.
8. Woo, M. M. M., Tai, C. J., Kang, S. K., Nathwani, P. M., Pang, S. F., and Leung, P. C. K. 2001. Direct action of melatonin in human granulosa-luteal cells. J. Clin. Endocrinol & Metab.; 86: 4789--4797.
9. Okatani, Y, Okamoto, K., Hayashi, K., Wakatsuki, A., Tamura, S., and Sagara, Y. 1998. Maternal-fetal transfer of melatonin in pregnant women near term. J. Pineal Res.; 25:129-134.
10. Cagnacci, A., Soldani, R., and Yen, S. S. C. 1995. Exogenous melatonin enhances luteinizing hormone levels ofwomen in the follicular but not in the luteal menstrual phase. Fertil. Steril.; 63: 996-999.
11. Cagnacci, A., Paoletti, A.M., Soldani, R., Orm, M., Maschio, E., and Melis, G. B. 1995. Melatonin enhances the luteinizing hormone and follicle-stimulating hormone responses to gonadotropin-releasing hormone in the follicular, but not in the luteal, menstrual phase. J. Clin. Endocrinol. & Metab.; 80: 1095-1099.
12. Tailleux, A., Torpier, G., Bonnefont-Rousselot, D., Lestavel, S., Lemdani, M., Caudeville, B., Furman, C., Foricher, R., Gardes-Albert, M., Lesieur, D., Rolando, C., Teissier, E., Fruchart, J. C., Clavey, V., Fievet, C., and Duriez, P. 2002. Daily melatonin supplementation in mice increases atherosclerosis in proximal aorta. Biochem. Biophys. Res. Commun.; 293: 1114-1123.
13. Cook, J. S., Sauder, C. L., and Ray, C. A. 2011. Melatonin differentially affects vascular blood flow in humans. Am. J. Physiol. Heart Circ. Physiol.; 300: H670H674.
14. Nishiyama, K., Yasue, H., Moriyama, Y., Tsunoda, R., Ogawa, H., Yoshimura, M., and Kugiyama, K. 2001. Acute effects of melatonin administration on cardiovascular autonomic regulation in healthy men. Am. Heart J.; 141:E9.
15. Kitajima, T., Kanbayashi, T., Saitoh, Y., Ogawa, Y, Sugiyama, T., Kaneko, Y, Sasaki, Y., Aizawa, R., and Shimisu, T. 2001. The effects of oral melatonin on the autonomic function in healthy subjects. Psychiatry and Clin. Neurosci.; 55: 299-300.
16. Arangino, S., Cagnacci, A., Angiolucci, M., Vacca, A. M., Longu, G., Volpe, A., and Melis, G. B. 1999. Effects of melatonin on vascular reactivity, catecholamine levels, and blood pressure in healthy men. Amer. J. Cardiol.; 83: 1417-1419.
17. Cagnacci, A., Arangino, S., Angiolucci, M., Maschio, E., and Melis, G. B. 1998. Influences of melatonin administration on the circulation of women. Amer. J. Physiol.; 274: R335-R338.
18. Wakatsuki, A., Okatani, Y., Ikenoue, N., Kaneda, C., and Fukaya, T. 2001. Effects of short-term melatonin administration on lipoprotein metabolism in normolipidemic postmenopausal women. Maturitas; 38: 171-177.
19. Wiechmann, A. F., Chignell, C. F., and Roberts, J. E. 2008. Influence of dietary melatonin on photoreceptor survival in the rat retina: An ocular toxicity study. Exp. Eye Res.; 86: 241-250.
20. Gagne, A. M., Danilenko, K. V., Rosolen, S. G., and Hebert, M. 2009. Impact of oral melatonin on the electroretinogram cone response. J. Circadian Rhythms; 7: 1421.
21. Rufiange, M., Dumont, M., and Lachapelle, P. 2002. Correlating retinal function with melatonin secretion in subjects with an early or late circadian phase. Investigative Ophthalmology & Visual Science; 43: 2491-2499.
22. Sheldon, S. H. 1998. Pro-convulsant effects of oral melatonin in neurologically disabled children. Lancet; 351: 1254.
23. Whittom, S., M. Dumont, M., Petit, D., Desautels, A, Adama, B., Lavigne, G., and Montplaisir, J. 2010. Effects of melatonin and bright light administration on motor and sensory symptoms of RLS. Sleep Medicine; 11: 351-355.
 


1 Guidance for Industry and Other Stakeholders: Toxicological Principles for the Safety Assessment of Food Ingredients, Redbook 2000, available at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPackaging/Redbook/default.htm.