According to experts who participated in the “Future View From the Top: Industry Leaders Forum on the Supplement Industry” panel discussion, the dietary supplement industry will likely witness changes in consumer activity and more emphasis on manufacturing standards within the next 18-24 months. This panel was held on the final day of The Conference, the Council for Responsible Nutrition’s (CRN) annual symposium on dietary supplements held in New Mexico.

The panel discussion included Steve Mister, president and CEO of CRN, as moderator; Janice Binger, president of the Natural Health & Nutrition Division of Archer Daniels Midland; Harvey Kamil, president and CFO of NBTY; and George Pontiakos, president and CEO of BI Nutraceuticals.

According to the panel, the presidential candidates’ focus on preventative healthcare could help the industry gain consumer growth, especially if that emphasis continues following the November elections. Panel participants also emphasized the need to maintain communication with consumers, the media and healthcare professionals post-election.

The slumping economy also made its way to the forefront of discussion, and Kamil, whose company has grown over the past several years in part by purchasing other dietary supplement companies, noted the economy is already affecting the availability of financial capital. He added that consolidation will continue and that financial issues will also play a role in shrinking the number of companies manufacturing and marketing supplements, stating, “With the new good manufacturing practices (GMPs), as well as other financial pressures, we’ll see that many companies can’t handle the financial pressures and the industry will shrink in size.” All panel participants agreed, however, that quality cannot be compromised.

The US Food and Drug Administration (FDA) released a pre-publication notice of proposed collection of information to the Office of Management and Budget (OMB) for review, following the draft guidance titled “Dietary Supplement Labeling Requirements and Recommendations under the Dietary Supplement and Nonprescription Drug Consumer Protection Act,” published January 2, 2008.

The FDA has since withdrawn the document, to be re-released in the near future; yet having seen the current version of the draft notice, the Natural Products Association (NPA) expressed concerns and is calling on association and industry members for action.

First, the NPA contends that the draft guidance's requirement that labels must contain a full US mailing address is not required by law and should not be mandated in the final guidance.

This is a departure from the longstanding provisions of the Federal Food, Drug and Cosmetic Act (FFD&CA). This provision presently requires food labels (including dietary supplements) to include the “name and place of business of the manufacturer, packer or distributor” and requires that the statement of the place of business must include the street address, city, state and ZIP code, but that the street address may be omitted if it appears in a current city directory or telephone directory.

The FDA currently estimates that the total cost for the industry complying with this new mandate is $222,400,000 (or $4,000 per SKU).

The NPA strongly encourages all affected members to submit company-specific comments during the 30-day comment period, which will begin immediately after the FDA publishes the draft in the Federal Register. Particularly, comments should include the estimated costs and operational impact the label changes would have on their firm. Aside from the costs that would have to be assumed by the company, members should consider including data regarding the increased cost that would have to be borne by consumers to make these unnecessary and non-statutory required changes.

The NPA does not anticipate the final version of the draft guidance to differ significantly from the previewed version. However, the NPA will continue to monitor the matter, notify members when the draft guidance is “officially” released, and identify any changes between this document and the final publication.

The American Herbal Products Association (AHPA) maintains that serious flaws exist in the rationale of a Citizen Petition requesting that the Food and Drug Administration (FDA) treat weight loss claims for dietary supplements as disease claims in comments filed with the agency on October 7.

“The FDA has correctly ruled that claims are allowed for supplements that may have a benefit in assisting normal and overweight persons to lose weight, and that claims for treatment of the disease of obesity are not allowed,” said AHPA President Michael McGuffin. “The petitioners’ argument that the FDA was unaware of information presented in their petition when it developed the existing rule is unsupported. It should also be noted that the petition relies to a large degree on data from a consumer survey that had significant flaws in its design, and that has been poorly interpreted by the petitioners.”

The petition was filed by the American Dietetic Association, the Obesity Society, Shaping America’s Health and GlaxoSmithKline Healthcare (GSK, Philadelphia, PA), marketer of non-prescription weight loss drug Alli®.

The petitioners claim that being overweight, while not a disease in and of itself, is a significant risk factor for other serious diseases. They requested that the FDA ban dietary supplements from making weight loss claims as structure/function claims under the Dietary Supplement Health and Education Act, and instead require dietary supplement weight loss claims to be limited to FDA-approved health claims. But the petition also states there is no evidence to support such a health claim, so the effect of granting the petition could be to provide Alli with a monopoly in the US over-the-counter weight loss market, according to AHPA.
 
“If the FDA granted this petition it would contravene Congressional intent and public policy, and would be unconstitutional under the First Amendment,” said AHPA’s McGuffin. “AHPA requests that the FDA deny the petition.”

AIBMR Life Sciences, Inc. (Tacoma, WA) announced the establishment of the Alexander and Laura Schauss Naturopathic Medicine Research Scholarship, named after the company’s founder, Alexander G. Schauss, PhD, FACN.

The scholarship program will begin in 2009, and will be available for fourth or fifth year naturopathic medicine students who plan to pursue research careers after graduating from the National College of Naturopathic Medicine, Bastyr University or the Southwest College of Naturopathic Medicine. The scholarship committee is comprised of graduates from the three selected naturopathic medicine schools, who have worked at AIBMR in various research capacities, including: Kathleen Jade, ND (committee chair); John Endres, ND; Irfa Qureshi, ND; Amy Clewell, ND; Sara Parent, ND; and Tennille Marx, ND.

The company also announced a donation to California Coast University (CCU, Santa Ana, CA), Schauss’ doctorate alma mater, to assist in reestablishing the institution’s doctorate programs.

"As an alumni of CCU's doctorate program, I know first-hand the value of this accredited distance-learning institution of higher education to busy and mobile students," said Schauss. "CCU's distance-learning program should be available to students at all levels.”

For more information call (253) 286-2888 or visit www.aibmr.com.

A case filed in May 2007 by Jacobs Farm/Del Cabo (Pescadero, CA) against pesticide application company Western Farm Service, Inc. (Fresno, CA) has reached verdict by jury in Santa Cruz County: the jury has found that the unintended contamination of organic crops caused by pesticides evaporating after application violated the rights of the organic crop grower.

The lawsuit claimed that Western Farm Service sprayed chlorpyrifos, diazinon and dimethoate on crops near Jacobs Farm and that those chemicals contaminated the farm’s dill, sage and rosemary.

Because Jacobs Farm is organic, even the trace presence of the pesticides made it impossible for it to sell significant portions of its 2006 and 2007 harvest from its 120-acre farm at Wilder Ranch State Park.

The jury found that Jacobs Farm was damaged in the sum of $1 million and has received payment in that amount from Western Farm Service. According to Jacobs Farm, this ruling sends a clear message to the California Department of Pesticide Regulation (DPR) that pesticides that evaporate and move to non-target property via wind or fog need to be strictly regulated.

Since October 2006, when Jacobs Farm first discovered trace residues of chlorpyrifos and diazinon, the company has tested each block of crops on Wilder Ranch before harvesting, and it has not sold any crops that tested positive for organophosphates insecticides.    

For more information about Jacob’s Farm call (650) 879-0580 or visit www.jacobsfarm.com.

Enzymatic Therapy, Inc. (Green Bay, WI) has released a new USDA Certified Organic supplements line, True Organics ™, which is 95 percent organic and contains no pesticides, harmful chemicals, artificial ingredients or preservatives.

"This is about helping our bodies, our minds and our planet," said Chris Kilham, medicine hunter and Scientific Advisory Board member. "As a certified organic facility, it makes complete sense for Enzymatic Therapy to take the lead on this."

The True Organics line includes: Organic Vitamin C, Organic Calcium, Organic
Iron, Organic Vitamin B12, Organic Cherry Fruit Extract and Organic
Cranberry.

For more information call (800) 783-2286 or visit www.enzy.com.