GOED: EPA, DHA Manufacturing Change Doesnt Create NDI

SALT LAKE CITYEven though FDA said it believes many products are being marketed illegallywithout new dietary ingredient (NDI) notificationsthe Global Organization for EPA and DHA Omega-3s (GOED) thinks the major eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) suppliers are on the right side of law, even those that have changed manufacturing methods since 1994, the year the Dietary Supplement Health and Education Act (DSHEA) became law.

While traditional refining processes have not changed in the past 60 years, new steps have been added to control contamination, such as molecular distillation, activated coal filters and vacuum filters, said Adam Ismail, executive director, and Harry Rice, Ph.D., vice president of regulatory and scientific affairs, GOED, in a presentation at the United Natural Products Alliances (UNPA)seminar on FDAs NDI Draft Guidance. These new steps take out undesirable compounds from the omega-3 oil, such as PCBs and oxidized cells.

They argued that because NDI notifications are required for safety reasons, FDA should not have an issue with changes in manufacturing methods that create safer products. Therefore, these manufacturing changes should not trigger an NDI, even though the draft guidance says manufacturing changes to an old ingredient do indeed create an NDI.

Beyond manufacturing method, Rice and Ismail said most EPA and DHA ingredients are not NDIs. Rice noted FDA affirmed menhaden oil as generally recognized as safe (GRAS) in 1997, and subsequently has issued no objections to nine companies that self-affirmed their omega-3 ingredients as GRAS. According to the draft guidance, using GRAS ingredients in a new product doesnt require notification, as long as the ingredient isnt chemically changed and it is used as was intended in the GRAS literature.

Of the omega-3 oils that were introduced to the market after DSHEA (algae, tuna, krill and yeast), and thus requiring a NDI notification, all have been submitted to FDA as an NDI by companies that market them.

For the oils marketed before 1994, Ismail said plenty of evidence is available to show they are old dietary ingredients (ODIs). He pointed to a number of advertisements, research studies and news articles for cold liver, salmon oil and whole-body fish in both ethyl ester and triglyceride forms.

Changes in EPA and DHA ratios should also not trigger an NDI, according to Ismail and Rice, because the U.S. government sold 90-percent DHA and 90-percent EPA products in the 1980s. Also, they noted natural fluctuations in the EPA and DHA levels of fish oils can be dramatic due to environmental conditions.