After over a year of delays, in the last few weeks, the food safety bill has experienced dramatic procedural twists and turns. But finally on Dec. 21, the House passed the Food Safety Modernization Act (H.R. 2751) as passed by the Senate (S. 510) on Dec. 19. The bill now goes to President Obama, who is expected to sign it into law.
But that is not the end of the story for food safety legislation. Congress still needs to approve the estimated $1.4 billion needed to hire 2,000 new FDA inspectors and pay for other requirements of the bill. A Republican-led Congress wanting to cut government spending may well kill that funding. Even if the bill is funded, the legislation will take 18 months to go into effect, and only after the FDA’s rulemaking (notice and comment procedure) results in the implementing regulations.
What does food safety legislation mean for supplements?
The original food safety bills—both the Senate and House versions—covered primarily conventional foods, not dietary supplements. It was clear from the origin of this legislation that the purpose and rationale was to prevent food-borne illnesses and to safeguard the food supply, both domestic and imported. The inclusion of provisions in S. 510 that applied to or targeted dietary supplements resulted from a form of “Let’s Make a Deal” among key Senators after Senator John McCain’s proposed Supplement Safety Act (S. 3002) of February was essentially, or mostly, withdrawn on March 4.
First, I want to note that the most onerous provisions of S. 3002 were withdrawn by Senator McCain and not inserted into S. 510; these omitted provisions include:
· Replacing the current “grandfathered-in” list of supplements (those supplements sold before October 1994) with a new “list of ‘Accepted Dietary Ingredients,’ to be prepared, published, and maintained by the Secretary,” that is, determined and generated by the FDA;
· Removing the supplement industry’s current ability to create new supplements if the ingredient has been in the food supply before October 1994 and has not been chemically altered;
· Mandatory reporting of even minor or incidental adverse events (reporting of serious adverse events is already required);
· Annualregistration not only of supplement companies (a one-time registration is now required under the Bioterrorism Act) but also of all products, including submitting labels and all “labeling” (product literature) to the FDA;
· Requiring downstream retailers to confirm that supplements and ingredients have been registered with the FDA, which would put a tremendous legal liability on retailers and potentially deter them from dealing with small supplement companies.
In a letter to Senators Tom Harkin, Mike Enzi and Orrin Hatch dated March 9, 2010, Senators McCain and Byron Dorgan acknowledged the “concerns with many of the provisions in S. 3002.” Signaling a retreat from S. 3002, McCain and Dorgan then wrote: “We were pleased to find common ground on some of the provisions included in [S. 3002] and that you are committed to working with us to incorporate those areas of agreement into S. 510, the FDA Food Safety Modernization bill.” The March 9th letter outlined the following four areas of “common ground,” which McCain and Dorgan vowed to work on collaboratively with other senators to incorporate into S. 510.
- · Requiring all dietary supplement manufacturing, processing and holding facilities to register with the Secretary of Health and Human Services;
- · Ensuring the FDA has the authority to issue a mandatory recall order if there is a reasonable probability that any dietary supplement is adulterated or misbranded or the use of such supplement could cause serious adverse health consequences such as death;
- · Requiring the Commissioner of the FDA to establish guidelines on new dietary ingredients (NDI’s) as soon as possible;
- · Mandating that the FDA notify the Drug Enforcement Administration (DEA) when a new dietary ingredient premarket notification is rejected because the product contains a synthetic anabolic steroid.
The second two of the four provisions above are not controversial. Indeed, they were and are acceptable and were already part of the legal landscape as of spring 2010. And the first two of the above listed areas of “common ground” were already part of S. 510.
Triggering FDA’s mandatory recall authority
However, the real problem occurred in the changed wording of the mandatory recall provision: As of March 26, under both of the food safety bills (S. 510 and H.R. 2749), the FDA would be given mandatory recall authority over foods and supplements if a product is:
- · Misbranded OR adulterated and
- · There is a reasonable probability of serious adverse health consequences or death
In practice, this means that a slight mislabeling issue in conjunction with the FDA’s judgment and finding of a “reasonable probability” is sufficient to trigger a mandatory recall.
Under the Food Safety Modernization Act, the FDA will also have increased authority over administrative detention, imported foods, and records inspections (which are already included in the supplement cGMPs). There will be a minimum schedule for FDA inspections of all food and supplement manufacturers (but on the order of every 3 years), and companies must cover expenses for FDA to re-inspect a facility. But note that dietary supplement companies would be exempt from the requirement that food companies and dietary ingredient firms establish hazard analysis and risk-based preventive controls (HACCPs) because they already have a requirement to comply with the new dietary supplement cGMP regulation.
In sum, the food safety bill would give the FDA more authority, especially in the area of mandatory recall powers, recalls which currently are manufacturer initiated and voluntary (though sometimes requested by the FDA, and refused at a company’s peril). A few critics have stated that the new food safety legislation would expand the reach of federal government without making food any safer. “The federal food bureaucracy needs to get smarter and better coordinated, not more omnipotent,” said Rep. Tom Price (R-Georgia).
We in the natural products industry should keep in mind—and not keep to ourselves—that the impetus for this bill were events like the huge salmonella outbreak from tainted eggs that occurred this summer, even as the food safety bill was pending. It is contaminated foods that kill consumers (an average of 3,000 people per year in the U.S.), not dietary supplements. Nothing in the mainstream media discusses how this bill would affect supplements, and apparently nobody on Capitol Hill is talking about supplements. Nonetheless, once the Food Safety Modernization Act and its regulations are in place then they may improve consumer confidence in safe supplements as well as in the food supply.
Susan Brienza, Esq. [email protected] or (602) 440-4885