Agency Response Letter GRAS Notice No. GRN 000273
CFSAN/Office of Food Additive Safety
July 25, 2009
Unit W215, Holywell Centre
1 Phipp Street
London EC2A 4PS
Re: GRAS Notice No. GRN 000273
Dear Mr. Lombard:
The Food and Drug Administration (FDA) is responding to the notice, dated December 17, 2008, that you submitted in accordance with the agency’s proposed regulation, proposed 21 CFR 170.36 (62 FR 18938; April 17, 1997; Substances Generally Recognized as Safe (GRAS); the GRAS proposal). FDA received the notice on December 19, 2008, filed it on December 19, 2008, and designated it as GRAS Notice No. GRN 000273.
The subject of the notice is baobab (Adansonia digitata) dried fruit pulp (BDFP). The notice informs FDA of the view of PhytoTrade Africa (PhytoTrade) that BDFP is GRAS, through scientific procedures, for use as an ingredient in blended fruit drinks and fruit cereal bars at levels up to 10 percent and 15 percent, respectively.
PhytoTrade’s notice discusses evidence supporting its GRAS determination including, a compositional analysis that indicates similarity to other fruit based ingredients and corroborating evidence of a history of safe use as a food ingredient in Southern Africa. PhytoTrade also provides information regarding the method of processing, an estimate of BDFP intake based on proposed use levels, and the possible presence of naturally-occurring toxicants.
PhytoTrade describes the identity and composition of BDFP. PhytoTrade states that BDFP is a free-flowing, coarsely milled powder derived from the fruit of the baobab tree (A. digitata). The color is described as off-white to cream, and the flavor as tart and acidic. PhytoTrade discusses the composition of BDFP noting that BDFP contains approximately 79 percent carbohydrates, 14 percent moisture, 6 percent ash, 2 percent protein, and 0.5 percent total fat, in addition to appreciable concentrations of the vitamins C, B1 and B2, as well as the minerals calcium, iron, magnesium, phosphorus, potassium and sodium. Compositional details provided by PhytoTrade include the specific fatty acids (predominantly palmitic, oleic, linoleic and alpha-linoleic acids), amino acids, carbohydrates (predominantly pectin and glucose) and organic acids (predominantly citric acid) present in BDFP. PhytoTrade includes a table of values which compares the macronutrient and micronutrient content of BDFP to a number of other commonly consumed fruits and legumes. PhytoTrade notes that BDFP is similar in nutrition and composition to the ranges of nutrients observed in other types of fruit and legumes commonly consumed.
PhytoTrade discusses the method of processing and provides specifications for BDFP. Baobab fruit is first harvested from the wild. The hard shell of the fruit is cracked open and the fruit pulp removed. The seeds and the fibrous material from the fruit pulp are mechanically separated. The fruit pulp is milled and screened using a fine mesh. Finally, the milled fruit pulp is stored in clean, food-grade packaging. PhytoTrade provides food-grade specifications for BDFP. These include limits on foreign matter, ash, lead, cadmium, mercury, arsenic, and microbiological contaminants.
PhytoTrade provides an estimation of daily intake (EDI) for BDFP. PhytoTrade calculates the EDI for BDFP based on data from the United States Food and Drug Administration’s 2005 Total Diet Survey (TDS), and the intended use levels of BDFP. The intended food categories are not listed in the TDS. Therefore, PhytoTrade used two related food products that PhytoTrade expects to have similar consumption levels. These are identified as fruit juice containing 10 percent fruit and granola bar with raisins. The intake values for these two substitute products were combined with maximum intended use levels for blended fruit drinks (10 percent) and fruit cereal bars (15 percent). PhytoTrade reports EDIs at the 50th and 90th percentile for these intended uses as 4.3 grams/person/day (g/p/d) and 8.6 g/p/d, respectively.
PhytoTrade discusses the presence of naturally-occurring toxicants in BDFP, noting that there are reports in the scientific literature indicating that BDFP may contain low concentrations of cyanide and appreciable concentrations of the organic acid oxalic acid. PhytoTrade notes that, based on batch analyses, the concentrations of both cyanide and oxalic acid are below the limit of detection of 5 milligrams per kilogram (mg/kg) for cyanide and 400 mg/kg for oxalic acid in BDFP. PhytoTrade further notes that the concentration of cyanide and oxalic acid is known to be higher in several commonly consumed foods, such as cassava flour in the case of cyanide and spinach and many other vegetables in the case of oxalic acid. PhytoTrade states that if these compounds are present in BDFP at the limit of detection, based on its review of the scientific literature and the EDI for BDFP, the exposures to these substances in food would not pose a risk to human health.
Potential Labeling Issues
Under section 403(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA), a food is misbranded if its labeling is false or misleading in any particular. Section 403(r) of the FFDCA lays out the statutory framework for the use of labeling claims that characterize the level of a nutrient in a food or that characterize the relationship of a nutrient to a disease or health-related condition. In describing the intended use of BDFP and in describing the information that PhytoTrade relies on to conclude that BDFP is GRAS under the conditions of its intended use, PhytoTrade raises a potential issue under these labeling provisions of the FFDCA. If products that contain BDFP bear any claims on the label or in labeling, such claims are the purview of the Office of Nutrition, Labeling, and Dietary Supplements (ONLDS) in the Center for Food Safety and Applied Nutrition. The Office of Food Additive Safety neither consulted with ONLDS on this labeling issue nor evaluated the information in your notice to determine whether it would support any claims made about BDFP on the label or in labeling.
Section 301(ll) of the FFDCA
The Food and Drug Administration Amendments Act of 2007, which was signed into law on September 27, 2007, amends the FFDCA to, among other things, add section 301(ll). Section 301(ll) of the FFDCA prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FFDCA, a biological product licensed under section 351 of the Public Health Service Act, or a drug or a biological product for which substantial clinical investigations have been instituted and their existence made public, unless one of the exemptions in section 301(ll)(1)-(4) applies. In its review of PhytoTrade’s notice that BDFP is GRAS for use in blended fruit drinks and fruit cereal bars, FDA did not consider whether section 301(ll) or any of its exemptions apply to foods containing BDFP. Accordingly, this response should not be construed to be a statement that foods that contain BDFP, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).
Based on the information provided by PhytoTrade, the agency has no questions at this time regarding PhytoTrade’s conclusion that BDFP is GRAS under the intended conditions of use. The agency has not, however, made its own determination regarding the GRAS status of the subject use of BDFP. As always, it is the continuing responsibility of PhytoTrade to ensure that food ingredients that the firm markets are safe, and are otherwise in compliance with all applicable legal and regulatory requirements.
In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to GRN 000273, as well as a copy of the information in this notice that conforms to the information in the GRAS exemption claim (proposed 21 CFR 170.36(c)(1)), is available for public review and copying via the FDA home page at http://www.fda.gov. To view or obtain an electronic copy of the text of the letter, follow the hyperlinks from the “Food” topic to the “Food Ingredients and Packaging” section to the “Generally Recognized as Safe (GRAS)” page where the GRAS Inventory is listed.
Laura M. Tarantino, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition