GM Lactoferrin Manufacturer Criticized over Food Plans
By staff reporter
April 10, 2008
A Californian rice and barley ingredient developer has been criticized by organic and sustainable agriculture advocate, the Center for Food Safety (CFS), over attempts to introduce specialist GM proteins into the US food supply.
CFS said Ventria Bioscience's genetically engineered, rice-derived recombinant human lactoferrin and lysozyme ingredients had no place in the food supply and may contravene federal food and drug law.
Interest in Ventria's lactoferrin ingredient had been shown by at least one manufacturer which has been subsequently withdrawn.
Maryland-based Cera Products, a manufacturer of sports beverages, reassessed its position, and called for more research into what CFS calls "pharmaceutical rice".
"Our company is not 'a likely partner with Ventria', nor are we including or plan to include any GMO rice in our products," said Cera president and chief executive officer, Charlene Riikonen. "We do not know enough about it for one thing, and certainly further research is needed to support any claims as well as issues and concerns regarding the GMO rice."
NutraIngredients.com was unable to gain comment from Ventria before publication.
Drugs and food
A September 2007 Congress amendment to Food and Drug Administration (FDA) regulations prohibits the "the addition to food of an approved drug or a licensed biologic".
However legal opinion varies as to the enforceability of this amendment due to the mutability of the terms 'drugs' and 'biological products'.
Hyman, Phelps & McNamara, a Washington DC-based law firm specializing in food and drug matters, said in a blog that the amendment did not clearly define what constituted a drug as was the case in the exclusion clause written into dietary supplements laws.
"The reference to 'drug' with its attendant uncertainties regarding the manifestation of intent, is not so bright a line as that provided [in the] dietary supplement exclusionary clause," the firm stated. "Contributing to the blurred distinction is the vague threshold of 'substantial clinical investigations'."
CFS suggests Ventria would require an FDA exemption if it sort to market its GM ingredients in medical foods or other products.
"This prohibition should stop Ventria's headlong rush to put its unapproved lactoferrin in the food supply," said CFS legal director, Joseph Mendelson. "FDA has enough problems handling traditional food safety threats, like Salmonella, without allowing people to be exposed to unapproved drugs in foods."
Yogurt, granola bars, performance drinks as well as oral rehydration solutions for children suffering from diarrhea are some of the food categories Ventria has shown interest in developing.
CFS, which opposes GM foods in principle, has targeted GM rice products and produced a report in 2007 entitled, A Grain of Caution: A Critical Assessment of Pharmaceutical Rice.
Lactoferrin is a protein that occurs abundently in breast milk and is therefore popular in the infant nutrition market.