UNDER CONSTRUCTION

 

NTEF Challenges Apeel’s Claims of Transparency, Non-allergenic and Safety.

     The NTEF is against the efforts by all grocers that refuse to identify produce they sell that is ‘tainted’ or as they claim ‘coated’ with Apeel’s ‘safe & healthy’ product.

    The NTEF is not rendering any opinions as to the ‘safe & healthy’ assertions that Apeel has provided on their website. Our intended purpose is the necessity for full transparency as to what grocers are selling. Consumers have the right to know what they are ingesting. What is, of some concern, that in the FDA’s correspondence to Apeel; ‘the process described in the notice to make MDAG was in a proof-of-concept stage of development, had not been commercialized…’ ‘mixture of mono and diacylglycerides derived from grape seed (MDAG)…’ [Emphasis added]

Apeel’s FDA GRAS Original Petition

FDA Response Letter GRAS Notice No. GRN 000648 to Apeel’s attorney Mark L. Itzkoff Dated December 13, 2016  [1]

EPA Label for Organipeel listed as a pesticide.  [2]

September 11, 2020, FDA Revised Letter referencing GRN 000886, July 13, 2020.  [3]

FDA Follow-up letter dated May 24, 2024, regarding supplemental submission received April 12, 2024.  [4]

     Statements made are rooted in the public disclosures from the Apeel Science Website. We have screenshot various links, in the event that they decide to ‘alter’ it in an attempt to do ‘damage control’ or challenge our statements. Home Page ; Products, News Center, Product Information, FAQ, A message from our leaders.

     We find the following sections from various FDA correspondences ‘interesting’, let the reader formulate their own opinions.

[1] Section 301(ll) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)

     Section 301(ll) of the FD&C Act prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FD&C Act, 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 our evaluation of Apeel Sciences’s notice concluding that monoglycerides are GRAS under its intended conditions of use, we did not consider whether section 301(ll) or any of its exemptions apply to foods containing monoglycerides. Accordingly, our response should not be construed to be a statement that foods containing monoglycerides, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).

Conclusions

     Based on the information that Apeel Sciences provided, as well as other information available to FDA, we have no questions at this time regarding Apeel Sciences’s conclusion that monoglycerides are GRAS under its intended conditions of use. This letter is not an affirmation that monoglycerides are GRAS under 21 CFR 170.35. Unless noted above, our review did not address other provisions of the FD&C Act. Food ingredient manufacturers and food producers are responsible for ensuring that marketed products are safe and compliant with all applicable legal and regulatory requirements.’

[2] EPA has determined that the ingredients in Organipeel classified it as a ‘pesticide’, under FIFRA Act.

[3] ‘For those foods where the peel or rind is removed prior to consumption, MDAG is not expected to migrate [emphasis added] to the edible portion, and the main source of consumer exposure will be in products with edible peels.

     Section 301(ll) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) Section 301(ll) of the FD&C Act prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FD&C Act, 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 our evaluation of Apeel Sciences’ notice concluding that MDAG is GRAS under its intended conditions of use, we did not consider whether section 301(ll) or any of its exemptions apply to foods containing MDAG. Accordingly, our response should not be construed to be a statement that foods containing MDAG, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll)

     This letter is not an affirmation that MDAG is GRAS under 21 CFR170.35. Unless noted above, our review did not address other provisions of the FD&C Act. Food ingredient manufacturers and food producers are responsible for ensuring that marketed products are safe and compliant with all applicable legal and regulatory requirements.’ [Emphasis added]

[4] ‘ In the supplement dated April 12, 2024, Apeel informs the FDA that at the time of submitting GRN 000 886, the process described in the notice to make MDAG was in a proof -of-concept stage of development , had not been commercialized, and that Apeel has no plans to commercialize [Emphasis added] the MDAG that were the subject of GRN 000 886.Further, Apeel indicates that the MDAG that Apeel is using are manufactured via the process described in 21 CFR 184.1505.

     Section 301(ll) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FD&C Act, 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 issuing this additional correspondence, we did not consider whether section 301(ll) or any of its exemptions apply to foods containing MDAG. Accordingly, our additional correspondence should not be construed to be a statement that foods containing MDAG, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).’[Emphasis added]