Companies using new materials would have to submit to the FDA a notification of intent to market, and the agency would have 120 days to rule. But fees are likely to be charged for the first time.
By Stephen Barlas, Contributing Editor
Packagers who have gone through the nail-biting experience of watching suppliers try to wheedle "approval" for a new packaging material out of the Food & Drug Administration may finally have a cure for that particular anxiety. Congress is near passage of an FDA reform bill that includes an amendment setting up a new faster pre-marketing notification (PMN) system. That amendment to the FDA bill (S. 830) passed a few weeks ago allows manufacturers to market new food-contact substances essentially new packaging materials simply by putting together a conventional data package proving the product safe and submitting it to the FDA. a similar bill was just passed by the House last month. The FDA will have 120 days to flash a red light. Barring that it would be full speed ahead to marketing. The Senate's passage of S. 830 will almost certainly be followed by President Clinton's approval of a final version of the bill. The House legislation (HB. 2469) includes the same 120-day provision. Currently packaging manufacturers have to submit an application to the FDA for a letter of nonobjection (LONO). That process often takes years. Two years ago the FDA published an exception to that requirement called the "threshold of regulation" (TOR) rule (see Packaging World Nov. '97 p. 78). Its purpose was to speed the approval of some low-risk new materials those where migration of the indirect additive into the food (and subsequently the eater's diet) was below 0.5 parts per billion (ppb). Manufacturers of those materials theoretically could begin marketing without going to the FDA. But the TOR rule has been something of a bust. Manufacturers of "low-migration" materials have felt they had to protect themselves by asking the FDA for a LONO. Often customers asked for those letters. A request for a LONO kicked off an FDA environmental review which ended up delaying many of those requested LONOs six to eight months sometimes longer. "The FDA's action under the threshold of regulation rule has been disappointing" says Jerry Heckman of Keller & Heckman the longtime attorneys for the Society of the Plastics Industry (SPI) as well as many individual additive and packaging manufacturers. Deadline by 1999 Ed Machuga an FDA official in the indirect additives branch admits the agency's record on LONOs is nothing to write home about. "We are going to try to lock into a four-month deadline by 1999" he says. Also the FDA will publish in the very near future a final rule dealing with the National Environmental Policy Act (NEPA). This rule according to Machuga will allow 87% of TOR applications-the request for LONOs-to fly through the FDA without any environmental assessment being required. The FDA reform bill set up the 120-day time clock for both the TOR submissions and many of those above the 0.5 ppb migration level. "Most food-contact substances that require approval via the longer petition process would qualify under this amendment" explains Laura Tarantino deputy director of the FDA office of pre-market approval. The amendment gives the FDA 18 months from the date of the bill's being signed into law to publish a final rule establishing the criteria for eligibility for the 120-day pre-market notification process. Companies could not submit PMNs until after that 18-month period. Currently companies do not pay fees to the FDA when they apply for either LONOs or food additive petitions. That will change under the PMN system. These new PMN fees will be set by the FDA after they take a look at prospective costs. The House version did not include user fees but the House/Senate conference was expected to endorse the Senate version with fees. "I hope they will be as little as $1 per PMN but we don't anticipate them exceeding $2 per PMN" says Heckman representing SPI. Even if more than one manufacturer wanted to sell the same new packaging material each would have to submit the data and notification to the FDA. This has the support of both the SPI and the FDA. "That way each notification would have in it all conditions of use" says Tarantino. The FDA would reserve the right to do a full-blown petition review for some small category of new food-contact materials. Both Democrats and Republicans supported the amendment. The same is true for the extension of the Prescription Drug User Fee Act (PDUFA) the real engine that pulled the reform bill. Democrats and Republicans the FDA and the drug companies all wanted the PDUFA renewed. However some of the legislative cars between the PDUFA engine and the packaging caboose were very controversial. OKs for health claims One of those amendments makes it easier for food companies to put "health claims" on their product labels. The Nutrition Labeling and Education Act of 1990 contained a whole set of rules on when and how companies could make nutritional and health statements on their labels. Nutritional content claims are statements like "low fat" and "low cholesterol." Health claims say such things as "High fiber diets prevent cancer." The FDA approved eight of those claims as part of a rulemaking in 1993 and has subsequently approved three others. But many food manufacturers argue that getting FDA approval for additional health claims is the bureaucratic equivalent of scaling Mt. Everest. For example in 1992 the Centers for Disease Control and Prevention (CDC) issued a recommendation that all women of child-bearing age who are capable of becoming pregnant should consume 0.4 mg of folic acid per day. It would reduce the risk of having a pregnancy result in a baby afflicted with spina bifida or other defects. In January 1993 the FDA published a rule saying companies could not make a folic acid/birth defect health claim. As a result of the ensuing uproar the agency reversed itself issuing a proposed rule in October of that year allowing the claim. Final regulations went into effect in March 1996. The Senate-passed bill allows companies to put health claims on their food products as long as those claims were based on authoritative published statements from scientific bodies of the U.S. government with official responsibility for public health protection or research directly relating to human nutrition. These would be agencies such as the National Cancer Institute the Surgeon General and the CDC. Also the substance such as folic acid which was at the heart of the claim would have to make a "material dietary contribution." As in the case with food-contact substances the company will have to file a PMN 120 days before it puts the health claim on labels. The FDA could use existing authority to block introduction of misleading claims. And the FDA can publish an "interim final rule" during that 120-day period stopping the company from using the new label. This ostensibly gives the FDA added enforcement power. Brian Folkerts vice president of government affairs for the National Food Processors Assn. says that there are not too many new health claims that have been endorsed by requisite U.S. agencies. "Most of the claims that could be approved are prospective" he notes.