863 New Ingredients, 10 FDA Reviews: What the New GRAS Rule Means for Food and Drink Makers

Since 2000, food and chemical firms have asked the FDA to clear a new food substance ten times. Over those same years they cleared 863 substances themselves. That gap is the whole reason a new rule landed this week.

On 10 August the FDA proposed a new rule. Firms would have to tell the agency each time they judge a food substance safe. The route is called GRAS, short for Generally Recognized as Safe. It has sat in US law since 1958. Since 1997 a firm has been free to hire its own panel and reach its own view. It could then start selling without telling the FDA.

What the rule does, and what it leaves alone

The rule makes the notice a must. It does not put the review first. A firm can still ship while the FDA reads the file. The agency gets 45 days to accept a filing and 180 days to reach a view. Firms that already went to the FDA and got a "no questions" letter are exempt.

The second part matters more. Things already on sale under a self-made GRAS call have to be filed too. The FDA calls this a time-limited streamlined pathway. In plain words: you get a window to hand over files on products you have sold for years. Then the window shuts.

The search costs more than the filing

Most food and drink firms do not hold the safety file for what is in their own products. The file sits with the supplier who sold them the flavour, the gum, the colour or the enzyme. Some of those suppliers have since been bought, merged or wound up. Some panels met twenty years ago and left thin notes.

That work is a hunt through supplier files, old specs and contract terms. No one wrote those terms with this rule in mind. Lawyers are the small part of the bill. Firms that keep a live ingredient register will file in weeks. Firms that do not will spend a year finding out what they sell.

The load is not spread evenly. A cola or a plain yogurt rests on things cleared decades ago. The risk sits in the fast-growing aisles: energy, protein, gut health and the whole functional shelf. New plant extracts, sweeteners and live cultures came in there on self-made calls. Those are the same aisles the big groups have spent two years buying into.

Why the biggest makers want more rules, not fewer

New York's legislature passed its own mandatory GRAS scheme in April and it awaits the governor's signature. New Jersey and Pennsylvania have bills in play. More than 100 state bills have gone after GRAS.

For a firm that ships to all fifty states, one federal rule is cheaper than three state ones. Americans for Ingredient Transparency is a group set up by large makers to fight state ingredient bills. On Monday it pushed Congress to write one national standard into law. The trade body for additive makers went further. It said a public notice rule "largely formalizes what responsible ingredient makers already do".

The public list is the change that lasts

Safety files will go into a public online list. Once your file is public, the FDA is not the only reader. Rivals read it. Retailers writing their own banned lists read it. Lawyers bringing claims read it. State law officers read it. A gap in your file becomes a fact anyone can point at.

The FDA also said it will weigh a missing notice. That comes into play when it picks which substances to re-open. A paperwork miss becomes a flag on your file.

The rule is open for comment for 120 days. The FDA admits its power to demand these notices is not settled law. The agency is asking Congress to put the duty in statute so a court cannot undo it. Either way the list gets built. Buyers, retailers and lenders will ask for your entry long before any court rules. Firms that treat the next four months as a filing job will be late. Firms that treat it as an audit of what they actually sell will be ready.