GRAS is continuing to be a major topic of conversation and legislation at both the state and federal levels, with bills at both likely to advance initiatives to red light self-affirmed GRAS (generally recognized as safe) substances.
Of most current concern on the state level is the New York Food Safety and Chemical Disclosure Act which, if signed by the Governor, will establish requirements for the reporting of GRAS substances. While this bill does not ban self-affirmed GRAS, it requires that the sale or use of any GRAS substance in food be detailed in a report submitted to the commissioner, which the commissioner is to make available in a publicly searchable database (with any trade secret information redacted, except safety data). With the bill focused on sale as well as use, it will impact any food business selling into New York.
The required report from a responsible company official is to include:
- The food(s) the substance is used in, level of use, and intended purpose.
- The statutory basis for the GRAS conclusion, attesting that it does not require federal premarket approval.
- Detailed identification of the substance, method of manufacture, and physical or technical effects.
- Estimates of dietary exposure, including amount of the substance (and any by-products formed) likely to be consumed.
- How the provided data supports the substance’s safety under its intended conditions of use, including both favorable and unfavorable reviews; with data based on publicly available information, not trade secrets.
Additionally, the food company is to agree to make all data and information used to reach the GRAS conclusion available to the New York Commissioner of Agriculture and Markets upon request.
Exempted from the reporting are substances for which FDA has issued a “no questions” GRAS letter; substances regulatorily recognized as safe for food or packaging; natural ingredients widely consumed in the U.S. before 1958 without known safety hazards; substances with effective premarket or new dietary ingredient notifications that received no FDA objection; and independently owned and operated businesses with 10 or fewer employees.
The bill, which also prohibits certain food and color additives, passed the State Senate and Assembly, and is awaiting formal presentation to the governor. Once that occurs, the governor has 10 days (excluding Sundays) to sign, veto, or make amendments to the bill; if no action is taken, the bill automatically becomes law, and the act would take effect in one year.
Although this bill does not ban self-affirmed GRAS substances, it does serve to require the reporting of these, identifying them and their basis for use, in a way that the current FDA GRAS requirements do not. Having this consolidated list, available to both the state and the public, enables the state to dive deeper into each GRAS use to review its safety and to potentially ban substances or particular uses individually rather than simply banning all self-affirmed GRAS. It also puts power into the hands of consumer groups, and the public itself, to push back on certain substances or uses through advocacy and/or their purchasing dollar.
Until we see the New York Governor’s signature or veto, we won’t know where this bill will lead. But we do know that the fight against self-affirmed GRAS is not likely to end any time soon – as further evidenced by the recently drafted U.S. House bill that would, similar to the New York bill, create a federally mandated notification system for GRAS substances and the creation of a public registry of GRAS determinations.
As all this shows, the self-affirmed GRAS train has not only left the station, it is gaining steam – and you need to be on board. We’ve said it before, and we’ll say it again (probably not for the last time!), take a renewed look at your ingredients to determine their status. Are they GRAS? If so, are they self-affirmed – by you or a supplier? What is the basis of the self-affirmations? Could you defend them against a New York, or federal, investigator? If not, we emphatically advise you to start now to seek alternatives for those substances or reformulation of the products, to protect your product lines and your business.
Having provided food safety consultation to the industry since 2013, TAG has the experience and expertise to assist you in your GRAS determinations and general food safety processes and programs. Give us a call!
