Regulatory

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.

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.

The European Food Safety Authority (EFSA; Parma, Italy) published its negative opinion on a health-claims application for beta-glucans on May 26. But the details of Leiber GmbH...s (Bramsche, Germany) Article 13.5 application may be of greater concern.

The USDA Center for Nutrition Policy and Promotion released a draft report for its 2010 Dietary Guidelines for Americans, last week'”a report that will ultimately form the basis for 2010...s Dietary Guidelines for Americans. Within the report...s language, dietary supplements receive mixed approval.

As of today, June 25, all dietary supplement manufacturers are now required by law to follow good manufacturing practices (GMPs). Since the GMP final rule was first inked in 2007, the entire dietary supplement industry has had 36 months to prepare itself for the changes. Now, even companies with fewer than 20 employees are required to be comply with the regulation.

In the case of Monsanto v. Geertson Seed Farms'”the first-ever Supreme Court case to be held on genetically modified (GM) crops'”the Supreme Court has ruled 7 to 1 in favor of lifting an injunction (established previously by a lower court) on planting GM alfalfa. Furthermore, planting and selling of said alfalfa is still prohibited until an environmental review is conducted and considered.

UAS Laboratories (Eden Prairie, MN) has announced that its DDS brand probiotics are now kosher-certified by OK Kosher (Brooklyn, NY). The company...s DDS line of probiotics, including DDS Acidophilus and DDS Junior, is available in 37 countries around the world. OK Kosher currently certifies over 300,000 products from over 1500 companies.

Ever since the European Food Safety Authority (EFSA; Parma, Italy) published its second batch of general health claims in February, much of the industry had been waiting for last week...s stakeholders meeting, where EFSA intended to clarify its procedures and offer advice on claims substantiation.  

A subsidiary of Nestlé S.A., the world...s largest food and nutrition company, has agreed to drop allegedly deceptive advertising claims about the health benefits of its children...s drink BOOST Kid Essentials, as part of a settlement resolving the Federal Trade Commission...s first case challenging advertising for probiotics.

Cyvex Nutrition (Irvine, CA) has received Generally Recognized as Safe (GRAS) status for its BioVin(R) full spectrum grape extract and BioVin(R) 20 grape skin extract, according to a company announcement made yesterday. The successful GRAS status qualifies the extracts for safe used in a wide-range of functional foods and beverages. The process involved an intensive review of safety and toxicology data by an independent panel of qualified experts.

By unanimous vote, the U.S. Senate has passed S.3307, the Healthy, Hunger-Free Kids Act, which is reported to be the biggest financial increase for school lunch programs in recent decades.

Up until July 13, the case for cultivating genetically modified organisms (GMOs) within the European Union (EU) was deadlocked: some member states support the practice (e.g., Spain and Britain), while others (e.g., Austria and France) have made moves against it.

With current Good Manufacturing Practices (cGMPs) for dietary supplements now fully in place, the Food and Drug Administration (FDA) has the authority to conduct cGMP inspections of facilities of all sizes. As FDA inspectors hit the ground, so, too, are inspectors from NSF International (NSF; Ann Arbor, MI).

Originally Published

While writing this issue's State of the Industry report, I recalled the parting line of my editor's page in our November/December issue last year: "Looks like we're headed into an action-packed 2010." And indeed, the dietary supplements industry has certainly seen its share of activity so far this year, positive and negative-from (for some) increasing sales and innovation to tighter regulations and media scrutiny.

Per usual, priorities in Washington are too numerous to count. But major legislation affecting the dietary supplement, food, and beverage industries has been waiting its turn. Here are some of the could-be laws awaiting votes in the Capitol. (As of July 2010)