The American Herbal Products Association (AHPA) has submitted a letter to Dr. Lane Highbarger at the Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition requesting the agency deny a food additive petition that would allow the use of ionizing irradiation on dietary supplements and dietary ingredients.
 
The petition that is the subject of AHPA’s letter was submitted by Steris Corp. in 2003, and proposed that the food additive regulations “be amended to provide for the safe use of ionizing radiation for the control of microbial contamination on dietary supplements, and ingredients used in the manufacture of dietary supplements, up to a maximum absorbed dose of 30 kGy” (kiloGray). AHPA became aware of the petition when it was referenced in the preamble to FDA’s final rule on current good manufacturing practices for dietary supplements on June 25, 2007.
 
In requesting that the petition be denied, AHPA identified several concerns, including that because “proper handling of these ingredients under current good manufacturing practice is usually sufficient to ensure that dietary supplements are not subject to microbial contamination that presents any risk to the health of consumers of these products… there is generally no need for ionizing radiation as a treatment for this class of goods.”
 
AHPA also noted that irradiation is currently allowed in the US for 11 food categories, and that in proposing the limitation of ionizing radiation for dietary supplements be established at 30 kGy, the petition “is suggesting that this limit be from three to 30 times higher than is currently allowed for all but two food categories.” These two exceptions, said AHPA, are for the sterilization of frozen, packaged meats used solely in the NASA space flight programs (at a minimum dose of 44 kGy) and for microbial disinfection of spices “when used as ingredients in small amounts solely for flavoring or aroma” (at a maximum dose of 30 kGy).

AHPA’s letter therefore noted that “Steris Corp. has proposed that only astronauts would be able to obtain foods treated with higher limits of ionizing radiation than dietary supplements and has apparently ignored the fact that, while spices are used in small amounts, dietary supplements may be consumed in quantities of several grams per day. Thus, dietary supplement consumers will be exposed to much higher levels of any material changes that occur in a supplement’s or ingredient’s characteristics or in its consequences of use, if any, as a result of the irradiation.”
 
AHPA’s letter also expressed concern that should this petition be approved, “the use of ionizing irradiation on herbal dietary ingredients will mask one of the factors that is currently relevant to the determination of ingredient quality,” since information about microbial levels and the presence of pathogens or yeasts and molds at any time during the handling of a treated ingredient would be lost. The letter stated a “particular concern in the case of pathogens, since even if pathogenic organisms are eliminated through irradiation, pathogenic by-products such as endotoxins or exotoxins may remain in the material.” The letter also went on to express concern that “the US will become the dumping ground for poor quality herbal ingredients from around the world,” since “irradiation of herbal ingredients is not permitted in many countries.”

A copy of AHPA’s letter to FDA to oppose this food additive petition can be found at http://www.ahpa.org/Portals/0/pdfs/07_1213_AHPA_Comments_Irradiation_Petition_Final.pdf

The Food and Drug Administration (FDA), on January 2, issued two Federal Register notices to announce the availability of draft guidance documents on the labeling of dietary supplements and nonprescription drugs, respectively, as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act. This law, which went into effect on December 22, 2007, requires marketers of dietary supplements and nonprescription drugs to maintain records of received adverse event reports associated with their products and to submit serious adverse event reports to FDA. The law also requires labels to bear “a domestic address or domestic phone number through which the responsible person… may receive a report of a serious adverse event.”

These new guidance documents specifically address three labeling issues:
• That a domestic address included on a label to satisfy the address or phone number requirement of the law must include “a full US mailing address that includes the street address or PO box, city, state and zip code;” or
• That a domestic phone number that serves to satisfy the address or phone number requirement of the law on a label must include the area code; and
• That FDA “recommends that the label also bear a clear, prominent statement informing consumers that the domestic address or phone number is for reporting serious adverse events associated with use of the product.”

In both of the newly issued draft guidance documents, the FDA states that it will exercise enforcement discretion for any new labeling requirements associated with this law until January 1, 2009.

“AHPA takes no issue with the FDA’s recommendation that phone numbers include an area code,” commented Michael McGuffin, president of the American Herbal Products Association (AHPA). “But AHPA is already on record as opposing a reinvention of the long-standing regulations that allows just the city, state and zip code to suffice to identify a company’s address.” Under current food labeling regulations, a company’s place of business need not include the street address “if it is shown in a current city directory or telephone directory.” Similar regulations apply for labeling requirements for drugs, medical devices and cosmetics.

“Of greater concern, however, is the fact that the FDA is suggesting that all dietary supplements and nonprescription drugs bear what must be seen as a warning statement,” added McGuffin. “This was not the intent of the law and the Senate Committee on Health, Education, Labor and Pensions clearly stated, in its official report on this bill, that it ‘does not require the label to make any statement other than providing the address or phone number.’ AHPA will strongly oppose any attempt by the FDA to rewrite this good law.” 

In support of its position on the need for a complete address, the FDA’s guidance claims that “when consumers notice the incomplete address (i.e., one without a street address of PO box number), they may decide not to submit a report to the responsible person because they believe it will not be received.”

“This is really quite stunning,” noted McGuffin. “If the FDA is stating that the information that has been required on food, drug, medical device and cosmetic labeling since 1938 is somehow inadequate to communicate to consumers, AHPA assumes that the FDA would seek a global change in the law to address any perceived inadequacy, and would not single out this industry and the OTC drug industry as targets for its hypothesis.”  

In a January 4, 2008 interview with VR, Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), was asked about the changed warning language potentially needlessly alarming consumers. He offered, “In the committee report, their language said expressly, ‘do not intend this to require additional language.’ The October guidance by the FDA made no mention of this, so we thought we dodged a bullet, but on Dec. 26 we saw an advanced copy of the FDA’s guidance, and we were very disappointed. When we reviewed this with the House and the Senate, everyone thought that place of business meant city, state and zip, but we’ve since found out it means a great deal more.”

“It’s a huge deal. Manufacturers have label stock ready two years in advance that they’ll have to discard. And at the end of the day, what advantage is this delivering to the consumer? [Consumers] have always been able to reach companies with questions or complaints,” Mister added. “This guidance is meant to become a standard for the industry. Consumers need to be cognizant that this will cost the industry a great deal of money and that cost will be born by someone. Will it be up to the manufacturer to absorb it, or will it be passed on to the consumer? Is it worth the added expense?”

Daniel Fabricant, PhD, VP of scientific affairs at the Natural Products Association, agreed with McGuffin: “We don’t read the statute the way the agency does.”

He added that the association is monitoring the FDA’s recommendations closely and will submit comments. “We want to see that the legislation is fair and appropriate and responsible.”

The newly issued FDA documents can be accessed online at:
• Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act <http://www.cfsan.fda.gov/~dms/dsaergu2.html> (December 2007)
• Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act <http://www.fda.gov/cder/guidance/Labelqanda_Cleared.pdf>  (December 2007)

Naturex SA announces the acquisition of Chart Corporation, a US company specializing in the production of natural flavoring ingredients for the beverage and flavor industries. Chart Corporation (Paterson, NJ) is located near the US headquarters of Naturex (South Hackensack, NJ). This strategic move further expands the presence of Naturex in the global natural ingredients market.
 
Naturex and Chart Corporation boast strong synergies, both in terms of their products and their customers. Chart Corporation adds to the Naturex product lines a comprehensive range of flavoring plant extracts in solid and fluid forms. Solid extracts are actually semi-solid, paste-like extracts that are ideal for flavor applications. Fluid extracts are botanical extracts in a liquid form that offer the advantage of being water soluble and are in high demand by beverage manufacturers as they provide cost-efficient solutions for ingredient solubility. Naturex offers oleoresins, essential oils and flavoring extracts through its NAT’Arom™ line. With the addition of the Chart Corporation product lines, Naturex will be among the world leaders in natural flavoring ingredients designed for the flavor and beverage industries.
 
Jacques Dikansky, President and CEO of Naturex, said, "This acquisition strengthens our position in the natural flavoring ingredients market and further establishes Naturex’s position as one of the global leaders in the field of plant extracts."
 
Claudia Molloy, president and CEO of Chart Corporation, offered, “I am delighted with the combination of both companies. It will enable us to provide the best quality service to our current customers and to compete more effectively for new business.”

From a growth standpoint, 2007 has been particularly remarkable for Naturex. The group continued to enjoy sustained development through organic growth (pro forma growth of 13% at constant USD rates for the first nine months of 2007), as well as the successful acquisition of two other companies: Hammer Pharma in January and HP Botanicals in February, both based in Milan, Italy. Additionally, Naturex established a UK sales office, Naturex Ltd., based in Oxford. Naturex has also launched several new products this year, enhancing its products portfolio with innovative offerings such as FraxiPure™, a patent-pending extract of Fraxinus Excelsior seed targeting the growing weight-loss market.
 
Naturex expects to expand its network in 2008, by establishing a subsidiary in China and opening a sales office in Germany, which will also cover the Benelux countries.

Solbar Industries Ltd., Israel, announced a management re-structure effective January 1, 2008, two months after Shaul Shelach was appointed CEO to strengthen sales efforts and invest in business development.

"We believe that the new organizational structure will help management take the necessary steps to lead the company in the coming years," explains Shelach. “By developing the protein business as part of Solbar's overall strategy, we expect to achieve a competitive advantage based upon the unique characteristics which Solbar brings to the global soy market."

Major changes will include:
• Assaf Gadish, who managed operations and supply chain, was appointed V.P. Sales and Supply Chain. Gadish will be responsible for sales of soy proteins and commodities (meal and oil), as well as procurement of soybeans. Soy protein sales will be separated from marketing and development.
• Gary Brenner, who managed marketing and sales of soy proteins for many years, was appointed V.P. Marketing and Development, with focus also on soy isoflavones. Brenner's experience and knowledge of the world of soy will serve to lead the implementation of Solbar's strategy, as well as new business development.
• Onn Oren, Ashdod Plant Manager, was appointed Manager of Operations, responsible for all the company's facilities in Israel. Oren will report directly to Solbar's CEO.
• Yossi Gohary, General Manager Solbar Ningbo Food Co., Ltd., operating in China, will report directly to Solbar's CEO. The company's China Sales Team will report to Solbar Ningbo.
• Adi Mizrahi, CFO; Liron Reshef, Human Resources Manager; and Trevor Meredith, Chief Technologist, will continue to serve in their positions, with no changes.

Solbar's facilities in Israel and China are certified ISO 9001:2000, HACCP, Kosher and Halal.

In a 79 to 14 vote, the US Senate approved its version of the Farm Bill that included funding and direction for key organic priorities, according to Caren Wilcox, executive director of the Organic Trade Association (OTA).

"The Senate Farm Bill includes important steps to help strengthen the safety net for organic producers and manufacturers," Wilcox said. "These measures include funding for organic research, data collection and transition to organic production, as well as eliminating the crop insurance premium for organic producers." Currently, organic producers must pay a 5% surcharge for crop insurance; yet, in times of loss, the producers receive the lower conventional price rather than the usually higher organic crop price.

The Senate version of the Farm Bill:
• Recognizes that increased funding is essential for the National Organic Program at the US Department of Agriculture at the full authorized level;

• Includes $5 million for organic data collection to help provide better price and yield information for organically-grown crops;

• Includes $22 million in new money for certification cost share to aid organic farmers;

• Bars USDA from charging a premium surcharge on organic crop insurance, unless validated by loss history on a crop-by-crop basis;

• Adds organic production as an eligible activity in the Environmental Quality Incentives Program;

• Adds to the Soil and Water Conservation Protection Loans a priority for those converting to organic farming practices and adds conversion to organic production as an eligible loan purpose;

• Provides $80 million over the life of the bill for organic agriculture research and extension; and

• Includes a sense of the Senate resolution that funding for organic research should be commensurate with organic agriculture’s share of the market, currently about 3 percent.

“We in the organic community appreciate all the support we have received for our priorities in the Senate. Thank you to Chairman Harkin; Senator Leahy, who led efforts to create a national organic program; and Senator Chambliss. With their leadership and interest, organic agriculture and processing will have access to the many federal programs typically reserved for non-organic production and processing.” Wilcox said.

Organic food is more nutritious and is richer in antioxidants than its non-organic counterparts, according to new research. Scientists leading this British project have called on the U.K. government to accept the evidence and encourage consumers to eat organic produce, according to UK-based The Organic Monitor.

The study, carried out by Prof Carlo Leifert at Newcastle University, found that organic fruit and vegetables contained more than 40 percent more antioxidants and could reduce the risk of cancer and heart disease.

Prof Leifert said the effect of eating organic foods would be the equivalent of having one extra portion of fruit and vegetables every day.

Researchers grew the fresh produce and reared cattle on the university’s 725-acre farm in Northumberland as part of the research.

Organic crops were grown alongside conventional crops including lettuces, cabbages, potatoes and carrots before their nutritional qualities were tested.

Scientists also found that organic milk contained almost 90 per cent more antioxidants than non-organic milk.

The findings call into question advice of the U.K.’s Food Standards Agency (FSA), which insists that organic produce is no more healthy than conventional produce.

The FSA’s current advice says: “Consumers may also choose to buy organic food because they believe that it is safer and more nutritious than other food.
“However, the balance of current scientific evidence does not support this view.”

The FSA has said it will consider the research and review its own advice on organic foods if that becomes necessary.