The effect of ongoing recalls in the food sector has bled into the supplement segment, prompting the FDA to take a more proactive inspection stance in an effort to thwart similar incidents. This year the FDA executed a huge amount of GMP inspections, focusing mostly on mid-sized companies.  

 

“AHPA files freedom of information requests for all of the facility inspections under the new GMP (21 CFR 111) and we examined about 40 of those, spread out a little over two years, from when the rule first came into effect for the largest companies, and we were able to analyze those to see what FDA was emphasizing,” commented Michael McGuffin, president of the American Herbal Products Association (AHPA), Silver Spring, MD. “What’s not surprising is that they’re emphasizing the new things: while they’re perfectly willing to look at things like cleanliness, rodent control, orderliness and properly maintained equipment—all the things we’ve always had under food GMP—but what’s not surprising is that their main focus is on the new parts of the rule, which is establishing and meeting specifications both for ingredients and for finished products, and that’s where well over half of the observations were.”

 

The attention to detail during inspections has also been ratcheted up. “These inspectors are really curious people and they want to know everything,” he said. “The new rule has given rise to more recent training. I was in business for 20 years and inspected twice. Those days are gone. You’re not going to have inspections every 10 years anymore.”

 

Andrew Shao, PhD, senior vice president, scientific and regulatory affairs for the Council for Responsible Nutrition (CRN), Washington, D.C., also noted the similar attention to detail on the part of the FTC as it related to the enforcement of advertising claims. “Both agencies were perhaps more aggressive than ever in these respective areas,” he said. “FTC came to agreement with two separate firms on consent decrees that some believe may set a new standard for what constitutes ‘competent and reliable evidence’.” 

 

The Enforcement Situation

 

New products and new ingredients are an important part of the dietary supplement market’s appeal but keeping a handle on them has proven difficult. Adulteration continues to pose a very real threat not only to consumers but to the credibility of the dietary supplement industry on the whole.

 

“Perpetrators appear to be paying little attention to the law or FDA,” commented Dr. Shao. “The consequence of this is two-fold: first, the criminal behavior of spiking products with drugs (approved and unapproved) can result in serious adverse events, and ultimately has the result of eroding stakeholder (consumers, media, Congress, FDA) confidence in the industry. Second, some will view the solution to the problem to be widespread policy change, which could impose tremendous burdens on the industry across the board, and would make the greatest impact on those already abiding by the law. 

 

“The industry and FDA must work together to find a solution before it gets to that point. There is no one approach that will solve this problem; a multi-pronged approach will be necessary.”

 

For now at least, it would seem that the brunt of that responsibility falls on the supplement industry itself, as it seems the FDA already has its hands full keeping tabs on new ingredients. Todd Harrison, partner, Venable LLP, Washington, D.C., asserted that FDA does not have the manpower to actively go after new dietary ingredients in the marketplace, which would thus dictate a two-fold regulatory strategy involving pursuit of high profile ingredients and reacting to safety issues. “For instance, purified synephrine is a questionable grandfathered dietary ingredient even though bitter orange is clearly a grandfathered ingredient,” explained Mr. Harrison. “However, because it is chemically similar to ephedrine, FDA may also take a stand in the muscle supplement industry.”

 

In the realm of claims, Mr. Harrison noted that the ripple effect of the FTC action against Iovate and Nestle has delivered the message that reliance on third party studies to justify claims won’t cut it anymore. The latest company to feel the wrath is POM Wonderful. “The FTC has clearly indicated in these consent decrees that violation of the Federal Food, Drug, and Cosmetic Act is also deceptive regardless of whether the claim is substantiated,” he said. “From my perspective, the FTC does not have the authority to enforce the FDCA and it is a huge jurisdiictional grab by the agency. Interestingly, state laws generally do consider it a deceptive trade practice to violate a state or federal law but that is not the case.  Again, however, litigating such a case is an expensive proposition and we should all watch the POM case unfold albeit being before an Administrative judge is more favorable to the FTC than being before a federal court.”

 

As worrisome as the claim issues has been the uptick in prescription drugs masquerading as dietary supplements. “Passing off Rx drug ingredients as dietary supplements is a criminal act,” commented Loren Israelsen, executive director of the United Natural Products Alliance (UNPA), Salt Lake City, UT, concurred. “Public safety is compromised and the industry’s ability to advance the work of full implementation of DSHEA is hampered. In terms of a significant imprint, this is the issue I worry about most.”

 

Politics as Usual?

 

The recent election shake up has also left supplement industry advocate groups wondering just how many political allies the supplement industry still has both in the present and the future.

 

“Our political supporters are still here today but we have every reason to be concerned about the stability of our supporters,” AHPA’s Mr. McGuffin said. “An article was published in The Hill where some recent polls said that Orrin Hatch might have suffered the same fate as Bob Bennet if he had been up for re-election this year. One of our true stalwarts is suddenly at risk in his home state and that would be of concern to us.”

 

Mr. McGuffin pointed to the loss of Russ Feingold in the U.S. Senate as well as the House’s David Obey, who resigned of his own volition, but said the industry continues to be grateful for the supplement-related friendships forged with Senators Hatch and Harkin, and Congressman Frank Pallone.

 

“But the Republicans are coming back with knives sharpened prepared to cut expenses,” he added. “Commissioner Hamburg said ‘reducing our budget would be a cautious conversation because we don’t have a lot of pennies to spare around here and there’s nobody that’s going to do our job if we don’t do it.’ Her statement reflected her clear and immediate attention to the change in the political landscape. She can’t protect the food supply without financing.”

 

Mr. Harrison, however, didn’t think there was too much to worry about. “Much has been made of the Republican takeover of the house but the fact of the matter is the FTC and FDA are run by political appointees of the Obama administration and they are firmly in-charge of these two agencies for at least the next two years, thus, the Republican takeover is not likely to have any impact on these agencies,” he said. 

 

The most immediate legislative matter at hand is the Food Safety Bill, which has still not passed Congress. “It is clear that the bill, regardless of whether it passes, will likely lead FDA to issue its long awaited guidance document on new dietary ingredients, which could capture as much as 60% of the ingredients that are presently marketed in the U.S.,” Mr. Harrison said. 

 

Each of the industry advocates agreed that the most important and far reaching issue at hand continues to be the national healthcare situation.

 

“We are growing older and fatter as a nation and the preventative prescriptions put forward in healthcare reform do little to change that. With that said, at least in the scientific community, there is a growing understanding of how nutrition plays an important role in health and emerging nutritional science is clearly promising, especially in the area of blood sugar control,” commented Mr. Harrison, who added that the factor poised to most impact the supplement industry will be simple economics. “Hiqh quality supplements are not inexpensive and thus are often the first thing to be cut from a person’s household budget. In the end, getting the economy moving again is very important to this industry.”

 

Mr. Israelsen said the dietary supplement industry would be wise to use the current economic circumstances as a platform to promote healthcare at the most basic level. “The U.S. has no coherent healthcare system. As costs rise, healthcare access becomes more remote to many and the fear of losing it all (job, home, health, solvency) due to illness is all too real. What are people supposed to do?” he said. “The dietary supplement industry’s central message should revolve around this. As Washington battles over what to do with national healthcare we should return to our basic message—eat well, supplement wisely and give yourself a fighting chance to find the path to continued health by your own means.”