Regulatory

Senator John McCain (R-AZ) held a press conference last week introducing the Dietary Supplement Safety Act of 2010. The proposed legislation, which has been cosponsored by Senator Byron Dorgan (D-ND), would amend the Federal Food, Drug, and Cosmetic Act (FFDCA), making a host of changes to operations of dietary supplement industry.

Newly proposed legislation would require FDA to step up research on nanotechnology. The Nanotechnology Safety Act of 2010 would give FDA $25 million between 2011 through 2015 to assess the health and safety implications of nanotechnology in 'everyday products,' and develop best practices for companies using nanotechnology.

In response to Senator John McCain's (R-Arizona) introduction of S. 3002, the Dietary Supplement Safety Act, Senator Orrin Hatch (R-Utah) held a nationwide conference call today for representatives of dietary supplement companies. Hatch echoed concerns that the bill would create 'additional regulatory burdens' on responsible members of the dietary supplement industry and would curb the current consumer availability and choices of dietary supplements.

Following an audit that deemed the U.S. Department of Agriculture...s (USDA) National Organic Program (NOP) enforcement of organic products too lax in recent years, USDA...s Agricultural Marketing Service (AMS) has promised to step up policing. AMS, which oversees the organic program, says that it will start increasing spot testing of companies operating under USDA...s certified-organic label, including companies that issue organic certification, to ensure compliance. It will also more strongly police products on store shelves that are labeled as organic.

The European Food Safety Authority (EFSA) has published its final draft of dietary reference values (DRVs) for carbohydrates, dietary fiber, fats, and water. EFSA came to its final opinions on various nutrients after having met with nutrition experts from European Union member states, following two years of submitted opinions on nutrients. EFSA...s Panel on Dietetic Products, Nutrition, and Allergies, crafted the final opinions which include the following determinations:

On April 5, the Food and Drug Administration (FDA) announced that federal marshals had seized contract manufacturer Beehive Botanicals... (Haywood, WI) proprietary line of bee-derived consumer products. FDA said that the products were misbranded as drugs on several websites by claiming to diagnose, cure, and prevent diseases such as asthma, dermatitis, and ulcers.

ESM Technologies (Carthage, MO), a supplier of eggshell and eggshell membrane wellness ingredients, has received Good Manufacturing Practices certification from NSF International.

In a recent ConsumerLab.com evaluation of alpha-lipoic acid supplements, only two-thirds of the brands tested passed quality review. Lipoic acid is a natural antioxidant that can help diabetics control blood sugar and reduce symptoms of peripheral neuropathy.

On October 15, FDA and the Federal Trade Commission together issued their first joint warning letter to www.drweil.com, a website associated with health guru Dr. Andrew Weil, for what the agencies called fraudulent H1N1 marketing claims. Among other things, the agencies took issue with a page on the website titled 'Swine Flu and You,' on which Weil gave advice on how to avoid contracting the H1N1 flu. On the same page, Weil suggested using his Weil Immune Support Formula product to help ward off colds and the flu.

Kellogg Co. plans to discontinue 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 adding to its packaging after the company began adding extra antioxidants to the cereals in question last year.

The landmark Patient Protection and Affordable Health Care Act signed into law by President Obama on March 23 includes several provisions that address complementary and alternative medicine (CAM) and dietary supplements.

Congressman Jason Chaffetz (R-UT) introduced new legislation to the House, this Tuesday, which would significantly alter the claims permitted on dietary supplements and health foods. HR 4913, the Free Speech About Science Act of 2010 would allow dietary supplements and health foods to run labels referencing 'legitimate scientific research' deemed permissible under language of the new bill. The bill would amend the Federal Food, Drug, and Cosmetic Act. It is currently co-sponsored by Representative Jared Polis (D-CO).

Following the European Food Safety Authority...s (EFSA) release of its second batch of Article 13 health claims opinions on February 25, companies began sharing concern over EFSA...s batch-by-batch approach. Now, a global petition is making headway. As of today, 382 companies have already signed on to what is being called the 'Health Claims Letter,' a petition addressed to European Commission president José Manuel Barroso, which calls for a reconsideration of EFSA...s method of releasing evaluations.

The European Food Safety Authority (EFSA) established an Acceptable Daily Intake (ADI) for the safe use of stevia as a food sweetener, last week.

As the U.S. Senate gears up for a new financial reform bill, the Restoring American Financial Stability Act, trade associations and business groups, including representatives of the food and supplements industries, are calling for major changes before further negotiations.

Tomorrow, the U.S. Supreme Court will take oral arguments in the case of Monsanto v. Geertson Seed Farms, the first-ever Supreme Court case to be heard on genetically modified crops. Geertson Seed Farms, an Idaho-based alfalfa producer, filed a lawsuit in 2006 opposing the USDA...s approval of a pesticide-resistant alfalfa developed by agriculture company Monsanto (St. Louis), known as Roundup Ready Alfalfa (RRA).

In order to help companies comply with the standards of cGMP documentation, the American Herbal Products Association (AHPA; Silver Spring, MD) has made available a new cGMP compliance tool, Good Documentation Practices: A Guide for the Dietary Supplement Industry.

A bill aimed at financial reform will not include broadened Federal Trade Commission (FTC) powers. The final version of the bill, the Restoring American Financial Stability Act of 2010 (S. 3217), will not include provisions that would have provided FTC with "additional authority [that] very likely would have led to advertising rules that would have undercut the protections of the Dietary Supplement Health and Education Act," stated the Natural Products Association (NPA).

Tahitian Noni International (Provo, UT) has petitioned for and received its third Novel Food approval for the noni fruit from the European Commission on Food Safety. The company...s noni puree and concentrates are now approved for sale across the European Union. Previously, the company gained approval for its noni juice and leaves to be used in preparation of other products, such as tea.

A European Commission (EC) court has published its review of a French court case concerning whether or not EC member states can set their own limits on maximum intake levels for vitamins and minerals. The original French proceedings involved food supplement manufacturers, including Solgar Vitamins (Ferrières-en-Brie, France) against French Ministries, including the Ministry for Agriculture and Fisheries.

For the last several months, the Financial Services Reform Bill has been the talk of Congress, with the Senate passing its own version of the bill, last week. Nutritional Outlook recently reported on a controversial provision that, if added to the final bill, would provide the Federal Trade Commission (FTC) with expanded powers to regulate industry.

HealthCo (Bloomingdale, IL), a division of NOW Health Group, has received Generally Recognized as Safe (GRAS) status for its Stevia FSE ingredient. The company contends that its Stevia ingredient is different from most other Stevia ingredients because it is enzymatically treated to remove stevia...s usual bitter aftertaste.

Health Canada has approved phytosterols (or plant sterols) and sterol esters for Novel Food use, according to Cognis Nutrition & Health (Cincinnati). Phytosterols, found naturally in plants, can compete with, and therefore lower, dietary cholesterol in the body.

A new bill introduced today demands that the Food and Drug Administration (FDA; Rockville, MD) implement the regulatory powers provided by the Dietary Supplement Health and Education Act (DSHEA) established in 1994. Called S.3414, the Dietary Supplement Full Implementation and Enforcement Act of 2010, the new bill has been introduced by Senators Orrin Hatch (R-UT), the original author of DSHEA, and Tom Harkin (D-IA). The bill also requires that FDA receive a minimum of $20 million in funding to aid enforcement.

Krill oil manufacturer Aker Biomarine (Oslo, Norway) announced last week that it has been granted permission to use the Marine Stewardship Council...s (MSC; London) sustainability label for the company...s Antarctic krill. Aker Biomarine produces krill oil and ingredients under the brands Superba and Qrill, and the MSC 'ecolabel' implies that the company only uses sustainable fisheries.

Dietary supplement manufacturer Wellington Foods Inc. (Long Beach, CA) is pleased to announce that it has received Good Manufacturing Practices (GMP) certification from the Natural Products Association (NPA; Washington, DC). In the independent, third-party audit, NPA gave the company an 'A' compliance rating in its certification for the dietary supplement industry. The company formulates, manufactures, and packages dietary supplements in both liquid and power forms. For more information on the company, click here.

To assist the dietary supplement industry with Good Manufacturing Practices (GMP) procedures, Blaze Science Industries (Lawndale, CA) and Tampa Bay Analytical Research Laboratories (Largo, FL) will be offering a one-day workshop in July in St. Pete Beach, Florida, according to Verdure Sciences (Noblesville, IN), a sponsor of the event.