A recent Expo East/SupplyExpo education session title, Your Suppliers Can Kill You, may not be that far from the truth. Even with recent life-threatening food safety situations like melamine-tainted products and steroid-spiked body building supplements, a significant number of food, beverage and supplement manufacturers are not concerned about auditing overseas suppliers, according to a recent Functional Ingredients magazine survey on Good Manufacturing Practices.
Functional Ingredients surveyed hundreds manufacturers and received answers from about 100 (see the study parameters below). The questions posed varied from: "How difficult is it to implement GMP's in the current economy?" to "Are you switching out branded ingredients for non-branded ingredients to make ends meet?" Most manufacturers said that given the recession, the GMP timing was poor, but they would make it. As far as replacing branded with generic ingredients, almost half of the respondents said they were not switching out branded ingredients, 21 per cent said sometimes and 1.5 per cent said absolutely yes, they are making the switch.
For the question, "Have you or are you intending to personally audit your suppliers?" the answer was troubling. As many as 23 per cent of the survey respondents do not plan to audit their international suppliers…ever. Eight per cent said they plan to and another 7 per cent said they will at least audit some of their international suppliers.
The answer flies in the face of GMP requirements and the Council for Responsible Nutrition's call for SIDIs protocol, which would offer a voluntary standard for the exchange of relevant and required information between dietary ingredient suppliers and finished product manufacturers. A CRN survey on the topic showed that among the trade group members 48 per cent felt that SIDI was very important.
The international supplier question contradicts comments made at Expo East by Dr. Vasilios Frankos, Director, Division of Dietary Supplement Programs for the FDA in the session, "Your Suppliers Can Kill You," Frankos reiterated that suppliers and manufacturers must agree on what constitutes good information and quality and if one doesn't have documented evidence of supplier qualifications, the Certificate of Analysis is not valid.
Functional Ingredient's editor Kimberly Lord Stewart and NPIcenter editor Len Monheit offered up their thoughts on this surprising disclosure:
KS: "I was stunned by the answer. One wonders if manufacturers are in a "don't ask, don't tell mindset" or whether they are simply sweeping the issue under the rug and don't plan to address it until an embarrassing problem, or worse deadly problem, arises. I assumed (you know what that does) that with food and supplement safety in the forefront of American minds, most manufacturers would at least be planning on auditing their international suppliers. For many months now, certain industry voices have pointed to the fact that bad habits die hard and that work-arounds are common practice for some suppliers and manufacturers. In light of their concerns and this survey, perhaps CRN's SIDI's should not be voluntary but instead mandatory."
LM: "Despite the fact that GMPs don't formally cover suppliers, as anyone should know, it's 'garbage-in, garbage out'. So one has to ask the question, how will a company qualify suppliers past anything beyond identity testing of a specific material using available test methods with this attitude?
Study: Functional Ingredients surveyed 300 manufacturers and received replies from about 100 manufacturers. Sixty per cent focus on supplements, one third were in food, another third in contract manufacturing, 20 per cent in beverages, 6 per cent in cosmeceuticals and 16 per cent in other (numbers do not add up to 100 per cent because of product overlap). For this particular question, we received replies from eighty-three manufacturers.