During a session titled, “Can pharma and dietary supplement omega-3’s co-exist”, at last week’s conference in Salt Lake City, GOED members discussed how omega-3 products are distinguished by regulatory requirements and marketing claims, and not by composition or biological activity.
Commenting after the session, Adam Ismail, executive director of GOED, said: “The question is not whether pharma and dietary supplement omega-3’s can co-exist. From a regulatory standpoint, they already do co-exist. This session was intended to raise awareness of the ways in which both sectors benefit from increased public awareness and research within the industry.”
Presenting at the session was Dr. Douglas MacKay, of the Council for Responsible Nutrition (CRN), followed by Naoyuki Tanaka, from Nippon Suisan Kaisal (Nissul) in Japan. Both presenters suggested that dietary supplement manufacturers view omega-3 drugs not as competition for market share, but as validating in the public eye the health-promoting benefits of omega-3’s.
“The co-existence of pharmaceutical and dietary supplement omega-3 fat products results in parallel efforts to increase public awareness while maximizing distribution channels and claims that can be made for EPA and DHA,” saidDr MacKay.
CRN’s Dr. Mackay presented an overview of the two categories and outlined differences in regulatory standards, distribution channels and allowable marketing claims. He pointed out that omega-3’s prescribed as a drug, although subjected to more stringent GMPs and strict specifications for purity and potency in their composition, do not differ from omega-3 dietary supplements in their biological activity.
“A drug is defined as a substance intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease,” explained MacKay, “whereas a dietary supplement is defined as a product taken by mouth that contains a ‘dietary ingredient’ intended to supplement the diet.” As noted, these definitions do not prevent the same material from existing as both a dietary supplement and a drug.
Mackay went on to explain the different claims that drugs and supplements can make. While the currently available omega-3 drug Lovaza can make the approved therapeutic claim to “lower very high triglycerides,” it cannot make the multiple structure-function claims (considered off-label use) that dietary supplements can make, including claims concerning eye health, prenatal health and immune function. Thus while Lovaza can claim it is “the only FDA-approved fish oil,” dietary supplements have considerable marketing flexibility and can appeal to multiple audiences for multiple reasons.
Tanaka affirmed Mackay’s conclusions and presented data from Japan showing how omega-3 dietary supplements and pharmaceuticals have co-existed for 20+ years and are even produced by the same company.