In late May, Senators Tom Harkin (D-IA) and Orrin Hatch (R-UT) introduced new legislation to provide FDA with additional resources so that it can continue to enforce the existing laws governing dietary supplements. Called the “Dietary Supplement Full Implementation and Enforcement Act of 2010,” it also requires FDA to file annual reports with Congress about how the FDA is regulating dietary supplements.

Offering their support of the bill were the Natural Products Association (NPA) and the Council for Responsible Nutrition (CRN), both based in Washington, D.C.

“While some have called for additional regulations on supplements, Senators Harkin and Hatch understand that the real need is to fully enforce the stringent statutes already on the books, to the full extent of the law,” said NPA executive director and CEO John Gay. “The way to get the bad actors out of the industry is by putting more cops on the street, plain and simple.”

Adding his thoughts, Steve Mister, president and CEO, CRN commented, “CRN is pleased to add its support of the Dietary Supplement Full Implementation and Enforcement Act of 2010. Further, CRN applauds Senators Tom Harkin and Orrin Hatch for their efforts to fully fund, implement and enforce the Dietary Supplement Health and Education Act (DSHEA) of 1994. CRN and its member companies have long advocated for more resources to help FDA better enforce industry regulation, and this bill is a step in the right direction to making that happen.”

The new bill will tighten product-specific enforcement and double funding given to the Office of Dietary Supplements (ODS) to expand research and consumer information about dietary supplements.

The bill would also provide FDA with additional resources over a five-year period to accomplish important regulatory mandates set out by DSHEA, such as:

• Assuring that manufacturing facilities are GMP compliant through additional facility inspections;
• Calling on FDA to issue clear guidance for new dietary ingredients (NDIs) and the submission of these NDI notifications, as well as the criteria for establishing a reasonable expectation of safety for these ingredients;
• Implementing an annual registration process for supplement manufacturers, packers and distributors;
• Requiring more dialogue between FDA and the Drug Enforcement Administration (DEA) so that anabolic steroids (or their analogues) do not reach consumers as a mislabeled supplement; and
• Developing appropriate consumer education initiatives that will create more informed supplement customers.

Senate Conducts Dietary Supplement Hearing

Also in late May, Senator Herb Kohl (D-WI), chairman of the Special Committee on Aging, held a hearing titled “Dietary Supplements: What Seniors Need to Know,” which discussed the marketing and manufacturing of dietary supplements.

In his opening statement, Senator Kohl called for dietary supplement companies and the products they sell to be properly registered with the federal government, so that FDA has the ability to identify and act on safety concerns. He also called for better labeling that includes warnings about potential side effects or dangers, and notification on products that contain ingredients known to have adverse effects or harmful interactions with prescription drugs. Finally, Senator Kohl called for the reduction and elimination of dangerous contaminants, and for stronger recall authority for the FDA.

Testifying on behalf of the Government Accountability Office (GAO) was Greg Kutz, head of its Forensic Audits and Special Investigations division. He presented the results of its recent “secret shopper” investigation, which found that in several retail establishments visited, the salesperson made inappropriate or illegal claims about dietary supplements.

Responding to these allegations, the NPA said it has always made clear through numerous channels including educational materials available on its website, and education at it’s tradeshow, that if a retail salesperson is misleading customers, offering medical diagnoses, or making drug claims about supplements, then that is a violation of the law. “While the findings of the GAO may be explained by turnover common in the retail sector, or by new retailers entering the market unaware of their obligations, any violation of the law is not acceptable,” said NPA’s Mr. Gay.

He went on to say that NPA has expanded its efforts to educate and train retailers and their employees on what can and cannot be said to customers. This effort initially will include the following:

• Development of a “tool kit” for retailers to use to train their staffs;
• Expanded training programs including live sessions at tradeshows, webinars, and teleconferences;
• Partnerships with industry media to broaden the reach of educational materials;
• More frequent and regular content on rules for salespeople in NPA publications and communications; and
• Development of a dedicated website with education and training materials to serve salespeople, retailers and customers.

Good News for Herbal Supplements

In his testimony before the Senate Special Committee on Aging, Mr. Kutz of GAO also reported that none of the 40 herbal products it tested as part of its investigation were found to contain heavy metals in amounts exceeding either FDA or EPA regulations governing dietary supplements or raw ingredients used in supplements.

Additionally, the report stated: “FDA and EPA officials did not express concern regarding any immediate health consequences from consuming these 40 supplements.” This sentiment was reiterated in a May 25 article in the New York Times, in which FDA principal deputy commissioner Dr. Joshua Sharfstein was quoted as saying he “was not concerned about the safety of the supplements tested by the GAO investigators.”

“The area of trace elements in dietary supplements is one to which AHPA has dedicated time and attention,” said American Herbal Products Association (AHPA) president Michael McGuffin. “AHPA is pleased manufacturers of all tested products appear to be aware of the ways good agriculture and manufacturing practices can minimize the level of trace amounts of these naturally-occurring metals in their products.”

In his comments to Congress, Dr. Sharfstein testified that since the dietary supplement good manufacturing practice rule went into effect in June 2008, FDA has conducted roughly 55 inspections, and “the majority of facilities have been found to be in substantial compliance.” He also expressed confidence in the balance DSHEA strikes between risk and benefit and noted the seriousness with which the dietary supplement industry takes supply chain issues.

CRN President Testifies At Senate Hearing

Testifying on behalf of the supplement industry at the hearing, CRN president Steve Mister reassured the more than 150 million Americans who take dietary supplements each year that, “The dietary supplement industry is committed to manufacturing and marketing high quality, safe and beneficial products that have a valuable role in a wellness regimen. This industry is likewise committed to ensuring consumers receive truthful, accurate and non-misleading information on dietary supplements.”

Mr. Mister pointed to the demonstrated track record of the industry for actively lobbying for stronger enforcement of the law under which the industry is regulated. He noted the industry—through its five trade associations—has developed a variety of voluntary, self-regulatory programs that address issues that potentially tarnish the industry, and pointed specifically to the $1.5 million unrestricted grant provided by CRN to the National Advertising Division of the Council of Better Business Bureaus to monitor dietary supplement ads to help ensure they are truthful and not misleading.
Mr. Mister advised that new legislation introduced by Senators Hatch and Harkin would provide additional funding and accountability for FDA in further enforcing the law, and he urged Congress to support that bill.

Finally, he referred to consumer research demonstrating that dietary supplement consumers are more likely than those who don’t take supplements to also engage in other healthy habits such as trying to eat a healthy diet, exercising regularly and visiting their doctors. “Dietary supplements help to preserve good health and help reduce the risks of certain chronic diseases. Vitamins fill in nutritional gaps, and are especially important when seniors fail to get a nutritious diet or aging itself reduces their bodies’ natural ability to absorb nutrients from conventional food.”