Sharfstein Doesn't Rule Out DSHEA Change

FDA principal deputy commissioner Joshua Sharfstein, MD, told the dietary supplements industry in October that FDA has no immediate plans to consider reforms to the Dietary Supplement Health and Education Act of 1994 (DSHEA). However, he did not rule out future change.

"Our priority is to use the tools of DSHEA," he said. "At the same time, I can't say if that's going to be enough. Industry has to be open to other solutions if we think they're needed."

Sharfstein made his statements at the Council for Responsible Nutrition's (Washington, DC) annual conference in California.

After September's Senate hearing on steroid-contaminated supplements, some lawmakers have questioned whether DSHEA laws need to be tightened to require premarket government clearance of dietary supplements, in order to catch tainted products.

For now, Sharfstein says that FDA will be increasing its efforts to take advantage of the enforcement tools that DSHEA currently authorizes. He did, however, concede that FDA is underresourced. "Some of the tools have been available for a while, but FDA can't get to [them] due to lack of resources."

Sharfstein said that one tool that would help the agency review new dietary ingredients (NDIs) would be for FDA to establish a list of "grandfathered" ingredients. "So far, we have been hampered by the fact that no verified list of grandfathered ingredients exists. FDA is not using NDIs as authority now, and we want to get to a point where we can do that." FDA has previously turned down lists suggested by some dietary supplement associations.

Sharfstein didn't offer a timeline on when FDA might establish a grandfathered list, but said that, "We all feel urgency for this."

The Smart Choices logo, as seen on boxes of Kellogg's Froot Loops cereal.

Food Brands Ditch Smart Choices Logo

Shortly after FDA's October announcement that the agency will begin enforcing against misleading front-of-package (FOP) nutrition labels, the Smart Choices FOP labeling program announced it was suspending its operations. Soon after, nearly all of the large food corporations that had been participating in the program announced they are dropping the Smart Choices logo.

This summer, the Smart Choices logo was adopted by many food industry giants, including ConAgra Foods, General Mills, Kellogg Co., Kraft Foods, PepsiCo, and Unilever. Many critics had decried the Smart Choices nutrition criteria as being too lenient, allowing foods high in sugar and fat to use the program's logo.

FDA commissioner Margaret Hamburg said that FDA will begin examining existing FOP labels on the market. The agency plans to develop a "single set of science- and nutrition-based criteria" that all FOP labels should abide by. This is the first time that the agency has taken an active role in overseeing FOP label claims.

Hamburg said that the agency could make "significant progress" toward its goal by the end of 2010. As a model, FDA will look to the United Kingdom's voluntary"traffic light" nutrition labeling approach, for which government defines the nutritional criteria that foods using FOP labels should meet. Hamburg says that FDA would also be prepared "to move toward a mandated approach, should that prove necessary."

In October, Connecticut attorney general Richard Blumenthal announced that he would investigate whether the food companies that helped to create and fund the Smart Choices program influenced the program's criteria standards.

Consumer Confidence in Supplements Rises

CRN data indicate consumer confidence in dietary supplements is steadily rising.

Consumer confidence in dietary supplements rose this year, says the Council for Responsible Nutrition (CRN). In October, CRN reported the results of its 2009 online Consumer Survey on Dietary Supplements.

Of those American adults surveyed, 84% indicated that they are confident in the safety, quality, and effectiveness of dietary supplements, compared with 81% who indicated that comfort level last year. The 2009 percentage is the highest since the CRN survey began asking consumers about their confidence level in 2001.

The latest results confirm a steady rise in consumer confidence in dietary supplements over the last several years. In 2007, 80% of American adults indicated a favorable level of confidence in dietary supplements, while 79% of American adults did so in 2006.

Despite a down economy, consumer usage of dietary supplements is also on the rise compared with last year. In 2009, 65% of American adults said that they use supplements, while 64% of those surveyed in 2008 said that they used supplements. (However, those percentages represent a slight decline in usage from 2007, during which 68% said that they use supplements, and 2006, during which 66% reported doing so.)

Those who decreased spending for supplements reported purchasing fewer supplements and switching to less-expensive brands. A small percentage reported purchasing more supplements this year for health maintenance.

Also up slightly this year is the percentage of consumers who regularly take a multivitamin. In 2009, 78% of those surveyed reported doing so, while 75% of supplement users reported taking a multivitamin regularly in 2008.

The 2009 CRN Consumer Survey on Dietary Supplements was conducted online from August 26 to September 1. A national sample of 2043 adults ages 18 and older were surveyed. The association says that weighting was used to balance demographics and to ensure that the sample accurately represented the U.S. adult population according to U.S. Census data.

Kellogg Ceases Immunity Claims for Cereal

Kellogg Co. is discontinuing use of the phrase, "Now helps support your child's immunity," on boxes of Kellogg's Rice Krispies and Cocoa Krispies cereal. The move was announced after a letter questioning the marketing claim was sent to Kellogg by San Francisco city attorney Dennis J. Herrera.

Herrera's letter requested that Kellogg provide evidence to back up its immunity claim, which Kellogg started putting on its packaging after the company began adding extra antioxidants to the cereals in question last year.

Herrera's letter also expressed concern that "the immunity claims may also mislead parents into believing that serving this sugary cereal will actually boost their children's health," especially when concerns over swine flu are currently so heightened.

Kellogg spokesperson Susanne Norwitz said that the company started adding antioxidants to the cereals last year, before the swine flu outbreak. Kellogg said that it will continue to feature the antioxidants in the products but will phase out the packaging with the immunity claim.

Industry: More Enforcement, Not New Laws, Needed to Stop Steroids in Supplements

Dan Fabricant testified on behalf of the Natural Products Association (NPA) at a September Senate hearing, saying that enforcing existing DSHEA laws is the best way to crack down on illegal steroids in dietary supplements.

The September 29 hearing, heard by the Senate Judiciary Subcommittee on Crime and Drugs, was convened to address the problem of dietary supplements, primarily bodybuilding supplements, being illegally spiked with steroid or steroidlike substances.

Senator Arlen Specter (D-PA), who called the hearing, questioned whether stricter legislation, such as FDA premarket clearance, is needed to tighten oversight of dietary supplements. Travis Tygart, CEO of the United States Anti-Doping Agency, also testified at the hearing in support of premarket clearance.

Representing the dietary supplements industry, Fabricant argued that stronger FDA enforcement of unscrupulous companies, not new laws, is needed. "Warning letters are a good start, but how many of those were followed by court action, which is well within the authority of the FDA to pursue? Likewise, to our knowledge, the Drug Enforcement Agency (DEA) has only proposed the listing of three additional compounds under the Anabolic Steroid Act of 2004—just three compounds in five years."

Fabricant's opinions were backed at the hearing by Sen. Orrin Hatch (R-UT), as well as by Richard Kingham, partner at law firm Covington & Burling, who also testified. Kingham stated that those not following current laws, such as DSHEA's new dietary ingredient notification provision or rules for a new drug application, would not likely adhere to any new legislation such as premarket clearance.

Sens. Hatch and Specter also questioned FDA representatives on whether enforcement was lacking. Michael Levy, director of FDA's division of new drugs and labeling compliance for the Center for Drug Evaluation and Research, maintained that FDA has limited resources to weed out steroid-laced supplements from the vast number of supplements on the market. Joseph Rannazzisi, deputy assistant administrator of the DEA's Office of Diversion Control, also described the prohibitively lengthy process required to schedule new steroids as controlled substances.

Hatch said that he blamed Congress for not providing FDA with enough support for enforcement. However, no definitive action was decided at the hearing. Hatch only suggested that FDA be more proactive in asking Congress for more resources if needed.

FDA Warns P&G for Drug–Vitamin C Combination

FDA has issued a warning to Procter & Gamble (P&G; Cincinnati) that two of the company's cold medications illegally combine vitamin C and drugs. The agency sent a warning letter to P&G on October 30. The products in question are Vicks DayQuil Plus Vitamin C and Vicks NyQuil Plus Vitamin C.

According to FDA, the combination of vitamin C and the Vicks medications have not been proven safe and effective. Moreover, the agency has restated its opinion that there is "insufficient data" to prove that vitamin C can help to prevent or treat the common cold.

In order to be marketed together, the products would have to be approved under FDA's new-drug approval process. FDA does allow some over-the-counter (OTC) drugs to be marketed without agency approval. However, those drugs must comply with FDA's OTC monographs covering labeling, formulations, and warnings.

CRN Supports Food Safety Modernization Act

The state of national food safety looks to be on the right path as the U.S. Senate held a hearing on S 510, the FDA Food Safety Modernization Act, this October. The bill, which was introduced by Senator Dick Durbin (D-IL) in March, proposes increased transparency measures and new authorities for the Secretary of Health and Human Services (the Secretary) to regulate food. And the Council for Responsible Nutrition (CRN; Washington, DC) was quick to voice its support.

"To date, this legislation represents what may be the best opportunity to lead a national, if not global, agreement on food-borne illness protection," said CRN president and CEO Steve Mister in an official statement the day of the hearing.

The official language in the bill is a bit more telling of why the bill has industry support.

Under the proposed bill, the Secretary would be provided a range of new authorities, including the ability to order "an immediate cessation of distribution, or a recall, of food." The Secretary would also have greater capacity in sharing and gathering information on food-borne illnesses with government agencies, including FDA, the Department of Agriculture, state and local agencies, and the public.

Inspections of national and international food manufacturing facilities would also be increased and authorized by the Secretary.

Annual registration of food manufacturing facilities would be ordered for, along with increased likelihood of facility inspections. Mister affirmed that such changes should be desired.

"Over the past few years, new regulations and laws, including the release of the good manufacturing practices...have brought renewed focus to maintaining consumer confidence in the quality of dietary supplements," said Mister.

As industry awaits further activity on the bill, it looks promising. As of the October hearing, the bill carried bipartisan support from 11 cosponsors: five Republican and six Democrat.

USDA Adds More Vitamin D Data to Nutrient Database

The recently released, updated version of the U.S. Department of Agriculture's (USDA; Washington, DC) National Nutrition Database has an added 3000 values for products containing vitamin D. For the first time, vitamin D values were added for some 20 species of fish. Vitamin D values were also added for foods fortified with the ingredient during manufacturing or processing, such as milk, orange juice, breakfast cereal, yogurt, and some margarine.

More than 200 new entries in total were added to the database this year. The database provides nutrition information for food items, including data on vitamins, minerals, and fatty acids, and is considered the major source of information about food composition in the United States.

FTC Revises Advertising Guides

The Federal Trade Commission (FTC; Washington, DC) officially revamped its Guides Concerning the Use of Endorsements and Testimonials in Advertising this past October. The Guides, last updated in 1980, went into effect in December and now include a handful of changes bound to affect the industry.

Some companies feel that use of the fine-print "results not typical" notice in advertisements is a form of improper safe harbor. Now, when "consumers" featured in advertisements have their results conveyed as typical, advertisers will be required to disclose what consumers should, in fact, typically expect from product use.

The revised Guides will also require celebrities to disclose their relationships with advertisers, regarding any product endorsements done outside "traditional context," such as appearances on talk shows or other social media.

Additionally, if an advertiser sponsors a study and uses it in an advertisement, the advertiser will have to disclose information regarding the relationship between the advertiser and the research organization.

FTC commissioners voted in the revisions by a vote of 4 to 0.