The Special Senate Committee on Aging held a hearing May 25 on Capitol Hill to hear testimony on the current state of regulations for dietary supplements, which have long been a growing part of the health regimens of senior Americans. The hearing featured testimony from representatives from FDA, the Government Accounting Office (GAO), the Council for Responsible Nutrition (CRN) and Consumer Union (CU); presiding over the hearing was committee chairman Sen. Herb Kohl (D-Wis.) and ranking member Bob Corker (R-Tenn.), accompanied by Sens. Orrin Hatch (R-Utah) and Al Franken (D-Minn.).
The Senators established the scope of the relationship between elderly Americans and dietary supplement use, and spelled out their respective grasp of the situation and any solutions they seek, have sought or have undertaken. Kohl said seniors are relatively in the dark on many aspects of supplementation, from potential drug interactions to existing adverse events trends. However, he assured, “Let’s be clear: no one [on this panel] is suggesting consumers shouldn’t be able to purchase … dietary supplements.” He suggested the need for increased resources and authority for FDA.
Admitting he takes a dietary supplement every morning, Corker suggested DSHEA would offer adequate protection for the seniors and the general public if implemented fully, adding focus should be on implementation before any new, replacement laws are considered.
Hatch opened by reminding the room many of concerns—disease claims, misleading marketing, contamination, adulteration, etc.—are already illegal under current regulations governing supplements, and these laws should be better enforced. He urged his fellow members to learn the history of DSHEA (Dietary Supplement Health and Education Act of 1994), as the basis of current supplement regs, and listed all the requirements that have emerged out of the unanimously passed act, such as GMPs (good manufacturing practices) and serious adverse event (SAER) reporting. He also brought up the delay in new dietary ingredient (NDI) notification guidance from FDA and, addressed critics of the reg by noting, “The entire time Sen. Harkin and I were working on this bill, not one member raised any concerns about the grandfather clause.” On premarket approval, Hatch noted FDA lacked resources to enforce the current laws. “It ahs become clear to me FDA has much higher priorities than dietary supplements.” He quipped, noting the agency has not asked for additional laws or authority.
Hearing, Part One
The first phase of the hearing kicked off with a review of GAO’s recent investigation into deceptive supplement marketing practices provided by Gregory D. Kutz, managing director of the Forensic Audits and Special Investigations, GAO. Kutz explained how, repsonding to a request from Sen. Kohl to look into supplement marketing concerns, GAO undertook a two-part investigation. First it engaged (visited or called) 22 storefront and mail order retailers in DC and Florida, posing as elderly customers. He reported disease claims found and misleading advice was given both in product literature and in retailer dialogue. He played a video of some such communications with retailers, and showed the panel two products with illegal claims on the labels.
Next, GAO purchased 40 single-herb supplements from manufacturers and had them tested by an independent lab recommended by FDA. They found trace amounts of various heavy metals in 37 of the products, but Kutz reported upon referring them to FDA and FTC, neither agency found the levels of concern relative to the public’s health and safety. However, Kutz said GAO was concerned that many retailers and marketers were aggressively marketing supplements, often using disease claims or suggesting customers swap their meds for supplements.
Nest up was Tod Cooperman, president of ConsumerLab.com (CL), who summarized some of his company’s lab findings that relate to seniors. He said when it comes to supplement buying, seniors are like kids in a candy store, except that the standards for heavy metals limits in candy are stricter than for supplements, which face no regulatory standard except from California Prop 65. He noted the common problems his company has found in supplements include contamination and failure to contain listed amount. However it was contamination that he focused on, stating FDA has neither set nor suggested a safe upper limit for heavy metals like lea and cadmium. While admitting the levels found in these supplements were not immediately toxic, he expressed concern that the effect is cumulative, boosted by exposure to such metals in other aspects of life, including the environment. Overall, he said they find many high quality supplements, but there needs to additional standards set, and FDA deeds resources to enforce laws on contamination and other issues.
I his prepared statement, Charles Bell, program director for CU, listed regulatory improvements his organization supports: mandatory manufacturer registration; expanded recall authority for FDA; more timely NDI guidance publication from FDA; stronger import quality safeguards, including inspections and enforcement actions; better information for consumers and medical providers, such as labeling of side effects/contraindications and data on emerging hazards and AER trends; quicker implementation of contamination safety laws; and a shift of the burden of proof (of safety) from FDA back to the manufacturers. Further, Bell said FDA is unable to provide info for many of the products it should be overseeing, including the increased number of imported supplements. “Does FDA really have sufficient resource to police companies in other countries?” he asked. In addition he said CU is concerned FDA has not looked closely enough at all the new supplements featuring nano-ingredients, saying seniors are likewise unaware of any potential interactions or side effects. He ended by expressing CU’s support of the Dietary Supplement Safety Act of 2010.
Closing out the part one testimony, Steve Mister, president of CRN, provided an overview of all the self-regulatory measures the supplement industry has implemented, reiterating some of the regulatory gains of recent years, such as GMPs and SAERs. He said the industry is committed to manufacturing safe products and ensuring consumers receive truthful, accurate and non-misleading information on the products. He echoed Hatch’s concerns about “bad actors” who, either through ignorance of existing laws or criminal intent, willfully break the law by peddling illegal claims, illegal advertising and contaminated/adulterated product. While CRN, other supplement trade groups and companies all have worked hard to advocate and urge passage of regs such as GMPs and SAERs, Mister wanted to put some perspective on concerns. He said most consumers don’t forsake conventional meds for supplements, but supplement users are more likely to engage in other healthy habits and be attentive to their health. He further noted a high percentage of doctors, nurse practitioners and registered dieticians are supplement users; millions of supplements have been sold with very few subsequent SAERs; and FDA and FTC have said they have ample authority under existing laws to address the many concerns being raised in this panel.
Mister suggested FDA has had limited resources, training and will to enforce supplement regulations fully, but the latest Hatch-Harkin bill (“Dietary Supplement Full Implementation and Enforcement Act of 2010”) aims to correct this insufficiency. “This bill will go a long way to providing funding for and accountability by FDA,” he said.
Still, mister promised the industry will do more to educate retailers on how to train staff to lessen the incidence of misleading advice from retailers similar to those reported by Bell in his video and testimony. He concluded supplements fill nutritional gaps in seniors’ diets, and added, “I’m confident we can all work together to address concerns under existing laws.”
Following the testimonies, the committee panel bombarded the witnesses with questions. Asked by Kohl what industry can do about egregious claims, Mister detailed CRN’s partnership with the National Advertising Division (NAD) of the Better Business Bureau, which reviews supplement advertising and issues recommendations to companies; anyone ignoring NAD’s decision is referred to FTC, which gives these NAD cases top priority, according to Mister. He further noted the Natural Products Association (NPA) has just recently introduced a retailer kit for its members that would help address these concerns. In addition to these programs, Mister said the trade organizations preach responsible, legal marketing and refer offenders to FDA. He noted achieving 100-percent compliance in any industry is unrealistic.
“We are a trade organization, not the police; we do all we can, but at some point need enforcement agencies,” Mister said, in response to a later repeat inquiry on the same topic.
The Senators also grilled Cooperman on his company’s business model, asking if manufacturers pay to have their products tested, and if results are made public. Cooperman explained CL has two programs: it selects products “off the shelf” and has them tested by an outside lab, and it will also test products submitted by manufacturers via its voluntary certification program. In both cases, manufacturers of failed tests are notified and given the opportunity to review the results and correct the problems. However, Cooperman noted only the CL-selected product testing results are made public, with the most pertinent data reserved for paying subscribers.
Under rapid fire from hatch, Cooperman answered CL is a for-profit company, the results are not peer-reviewed, and there is no audit program in place for its labs. Cooperman noted CL sends all results to a second independent lab for verification, and there is currently a lack of laboratory standards from FDA for supplements.
When asked by Franken what can be done to correct the common problems reported in CL testing, Cooperman said one of the biggest issues is there are no quality standards built into GMPs or DSHEA, and the manufacturers are left to pick their own standards and determine their own testing.
However, under subsequent questioning, Mister later addressed this misconception, stating there is no loophole in the GMPs allowing companies to wantonly choose any standards and testing that benefits its bottom line. He said GMPs do provide flexibility during inspection for the manufacturer to demonstrate to FDA how their identity testing and quality standards are appropriate for the materials. “A company just can’t pick any standard,” he said. “It must be scientifically defensible to FDA during inspection.”
The focus shifted back to claims for most of the Q&A session. There was confusion on whose jurisdiction covered which type of claim violations, but Mister explained FDA deals with anything on the label, while FTC deals with all other advertising materials. Hatch asked for confirmation that under current laws companies and individuals who make disease or misleading claims are breaking the law. Mister confirmed these parties risk criminal punishments, saying labeling the Food , Drug and Cosmetic Act is a criminal statute that would mean all sorts of legal trouble for labeling violators.
Bell was relatively quiet during Q&A, as his fellow witnesses faced most of the questioning, but he did tell Franken an advanced medical degree might be needed to sort through all the complexities of supplement-drug interactions and other health and safety data. When asked if CU’s call for manufacturer registration wouldn’t be satisfied by the recent bioterrorism act, which includes mandatory registration of all food companies, Bell replied the required registration details aren’t enough, and an expansion would provide consumers more information. Also, when Corker asked if Hatch’s new DSHEA implementation bill wouldn’t address a couple of the recommendations/concerns outlined in his testimony, Bell replied CU would like to see mandatory non-serious AERs, which would give FDA a fuller record to track emerging problems. He said “serious” equates to hospitalization and major threats to health and life, but events like headaches should also be reported. He also advocated increased disclosure of interaction and side effects, arguing pharma and OTC can handle all the disclaimers, whereas with supplements, problems are caught after they go on the market.
Mister, under redirect from Corker, countered OTC and supplements have the same AER rules, and submitting to FDA every minor incident consumers think might be associated with a supplement would place undue burden on both the supplement industry and FDA. However, he noted the current supplement AER law mandates all AERs be kept on hand for up to six years and surrendered to FDA upon request.
Hearing, Part Two
The second phase of the committee hearing featured Joshua Sharfstein, assistant deputy director of FDA, who explained DSHEA balances access and risk. He said it is clear consumers want access to dietary supplements, which is provided by DSHEA, and the onus is on FDA to tend to the risk part of the equation. This includes finally getting out the guidance on NDIs, stepping up enforcement and fully implementing GMPs. For the most part, FDA is striking the right balance, he contended, adding, “The area of most concern for FDA is in the pharmaceutical spiking of dietary supplements.”
When questioned about FDA’s efforts against disease claims, Sharfstein said the agency is very serious about such claims, and it pursues enforcement action when it can. “Enforcement action takes a while ,” he said, noting FDA works with the U.S. Attorney’s Office on enforcement actions. “We can get money back for consumers and press criminal charges, but it takes time.” He further said judging the legality of claims can be challenging. A “cures cancer” claim is easily tagged illegal, but the wording of other claims can make decision more difficult.
Enforcement of spiking or adulteration is also problematic for the agency, as Sharfstein explained a lab analysis is needed, which can be time-consuming. He said it will take a collective effort from science, law and industry, as well as plenty of resources, to address pharmaceutical spiking effectively.
To questions of outreach, Sharfstein said the agency can create guidelines so retailers would better know legal claims from illegal claims, but retailers are not the place to catch problems. “The real problem is the internet,” he said.
Ultimately, Hatch and the panel wanted Sharfstein’s take on funding needs, but the assistant deputy would only say that he thinks the agency is “on track,” with the NDI guidance pending—possibly be this year’s end—and an expected 250 GMP inspection in 2010. “There are 1,500 companies out there,” he reminded. “With more funding, we’d do more. It’s frustrating all the pieces aren’t in place, but we are seeing them fall into place.” He said funding is not the only issue challenging FDA in its efforts to fully implement DSHEA, including GMPs and guidance for NDIs. It has been 16 years since DSHEA passed, but Sharfstein assured, “We are committed to implementing DSHEA.”