As the dietary supplement industry observes the 20th anniversary of the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA), people invariably ask: "If we could go back and pass the law again, what would we change?" I know I would add carrots. The “sticks" are already written into the law; now it’s time for some “carrots"incentives for good behavior. That’s what consumers deserve because when it comes to “sticks," FDA too often relies on twigs instead of bringing out the big branches.
Consumers need help separating the good guys from the bad guys. In the fiscal year (FY) 2013 alone, nearly one-third of the supplement firms that FDA inspected for GMPs (good manufacturing practices) were issued a citation for “official actions indicated" (OAI). The records for 2012 were equally poor. A quick analysis of the warning letters to dietary supplement firms during the past four years (since the GMP regulations became fully effective) revealed FDA has issued more than 125 warning letters related to GMP non-compliance. That means the problems identified during the inspections were not adequately addressed to FDA’s satisfaction even weeks afterwardand in some cases, not at all.
These violations, in many cases, are not inconsequential. Some of the observations FDA recorded were for issues such as the failure to conduct any identity testing on incoming ingredients, the failure to have a batch record to document that each lot is being made to a pre-determined recipe or specification, and the failure to test final products to assure what’s in the bottle matches what’s on the label. These are serious concerns for anyone marketing a product that consumers will ingest on the promise of health and wellness. It’s no wonder bystanders who watch this industry caution consumers about the quality of some of these products.
But let’s be clear: this is not the mainstream industry. A lot of the firms named in warning letters are companies I’ve never even heard of. Conversely, many Council for Responsible Nutrition (CRN) members, and nonmembers too, have endured multiple FDA inspections in the past three years under the requirements of CFR part 111 and passed their inspections with flying colors. They have made substantial investments of time, money and personnel to back up their commitment to high-quality products. Their pledge to their consumers is unquestioned.
But how is a consumer to know that? The Federal Food, Drug & Cosmetic Act (FD&CA), in a provision that pre-dates the passage of DSHEA, expressly prohibits the use, in labeling, advertising or other sales promotion, of any reference that the product is in compliance with the law.
FDA attorneys explain that this prohibition appears for two reasons. First, in the days when it was enacted, Congress did not want firms to use their inspection reports for commercial reasons. This was before the days of the Internet, Google and Consumerlab.com. FDA inspections were intended to be the “floor"the bare basics of what was expectedso Congress didn’t want reliance on passing an inspection to be a surrogate for product quality. Secondly, an FDA inspection is a snapshot, not a live webcam. It’s an evaluation of a moment in timewhat was going on in that facility on that date, not what currently may be taking place live. A company could have a tremendous inspection on one day, but could fall apart on the nextalthough that’s highly unlikely.
The flip side of offering “carrots" is using “sticks" to coerce compliance. The FD&CA offers FDA plenty of sticks when it comes to non-compliant supplements: detentions, recalls, seizures, civil fines and even criminal sanctions for violations. DSHEA decrees that a dietary supplement prepared under conditions that do not meet GMPs are per se adulterated under the statute [21 USC §342(g)]. That’s a tougher requirement than for food or drugs for which FDA must show that the failure to meet GMPs causes actual adulteration to the product; for supplements, evidence of the violation is enough.
The problem with the stick side of the equation is FDA seems to be reluctant to use big enough sticks to do the job. Although warning letters are common, recalls and civil penalties for violations are not. Even months after a failed GMP inspection, these firms continue business operations. Whether it’s because of limited resources and competing priorities, lack of interest by FDA’s Office of Compliance, or lack of political follow-through by the administration, there’s a credibility problem for FDA and for our industrytoo few enforcement actions and too many companies still ignoring the GMP regulations result in a confidence problem for both.
Let’s face it, if FDA were using the “sticks" DSHEA gave it, industry wouldn’t need to brag about companies that are simply following the law. But in light of the current marketplace for dietary supplements, it’s time to reconsider this rationale. When one-third of FDA’s inspections result in a failing grade, and another third requires voluntary action by the firm to get compliant, shouldn’t manufacturers who are meeting those requirements be able to tell consumers? Nothing prevents journalists or consumer action groups from announcing which firms receive warning letters. Third-party certification groups routinely test products and announce which ones “failed" their tests. All that negativity tells consumer what not to take, but doesn’t help them navigate the supplement aisle for quality products.
If FDA can’t make the “sticks" stick, let’s consider making “carrots" an option. Telling consumers their brand of supplement is made in a GMP-compliant facility just might let market influence drive non-compliant firms out. It’s one more way to allow firms that meet GMPs to rise to the top.
Steve Mister is the president and CEO for the Council for Responsible Nutrition (CRN, crnusa.org), a trade association representing the dietary supplement industry.