The title is synonymous with the expression, “Why should I pay you tens of thousands of dollars and wait 4-5 weeks, when I can have the same answer by the end of the week for $5K from someone else?” “A good point,” I respond, “it all depends on your appetite for risk.”
The above dialogue is a common one in consulting and usually refers to an opinion on the safe use of an ingredient, or a GRAS determination. The manufacturer has a new ingredient that he intends to add to food or use as a dietary supplement, but doesn’t have the depth of bench on his staff to generate a supportable opinion on safety. He needs the documentation in case the unthinkable happens — the FDA, FSIS or a third-party auditor asks for his supporting documentation on the safety and compliance of an ingredient as part of a routine inspection or audit as permitted under the Food Safety Modernization Act (FSMA). He knows the possibility of FDA knocking on his door is fairly remote, but if the unthinkable does happen and FDA does ask for documentation on the safety of his ingredient and he fails to deliver a convincing assessment, the company will experience a public humiliation via a warning letter or worse, a demand for a recall and possible penalties. Just a warning letter is enough to damage brand reputation or precipitate lawsuits from customers using the ingredient in their products.
In another scenario, marketing comes up with the idea of promoting the addition of a commonly used food ingredient to a food or dietary supplement, but at a much higher level than historically used. The higher level will supply a benefit that marketing can tout as an added value to the product or allow claims of “new” and “improved”. However, this new level of use is much higher than any previous GRAS or food additive regulation has cited. An opinion on the safety of this new level of use of this is needed to be compliant with the law. The in-house regulatory person has come up with a four- to five-page summary using Google®, Wikipedia® and a search of the FDA website showing use of this type of substance since the early 1970s, but not at the new level of use and, although there appear to be some animal studies supporting safety, he has no idea on the validity of these studies. The summary is competently written and the in-house person has been diligent, but he has no claim to expertise and not much in the way of tools to research the science or determine exposure levels of the ingredient by the consumer — two factors that are known to be critical in support of any claim of safety. The alternatives are to roll the dice and hope that FSMA inspection never occurs, go to the consultant that promises a quick turn-around and tells the manager what he wants to hear (no matter the reality) or call Burdock Group and see how much that in-depth, scientifically-backed and documented assessment (perceived as the “Cadillac®” of assessments) is going to cost.
However, before blindly signing up for a consultation, the manager begins to sort out what he really needs in an assessment.
- Identity of the ingredient: Easy enough — go to ChemID at the NIH and get the CAS number and synonyms. But in reality, there is much more that goes into identifying and characterizing an ingredient.
- Regulations: Search the FDA website for the CAS number and the synonyms to see if there are any prohibitions — if it is listed in the Code of Federal Regulations (CFR) section 189, it cannot be used in food; if it is listed as GRAS (§184), ensure changes to the use of the ingredient do not require a food additive petition or other restrictions. Be aware that you cannot search for a CAS number in the CFR and the CFR does not have a list of synonyms. If there is a regulation permitting use, does it refer to specifications in the regulation or refer to the Food Chemicals Codex?
- Consumption: In 21CFR§170.3(n) there is a list of 43 food categories, most of which permit addition of ingredients, but there is no indication of how much of each category is consumed — the Estimated Daily Intake (the EDI) is critical and must be less than the Acceptable Daily Intake (ADI), which may have been set by a foreign authority and you would have to justify the extra intake. However, consumption cannot be determined by saying that you will add X amount to some categories and not others — you need accurate quantitative data of the amount of different foods consumers actually eat. In addition, you soon find out that this list of food groups was generated on the basis of 1972 survey data and is woefully out of date. In a discussion with Burdock Group you find that Burdock Group has proprietary software that generates accurate consumption of thousands of food products surveyed by the USDA every two years.
- Searching for safety (toxicity) data: You know Google® and the NIH have information, but how well organized and accessible is it? You find that Burdock Group uses proprietary software to search commercial databases that make a business out of compiling scientific publications. The possibility of not finding information on a particular ingredient is remote.
- Obtaining publications: Although the commercial databases provide abstracts of the publications to see if they may have usable content, the full publication is rarely available. Does this mean a trip to the local medical school library? Burdock Group has the ability to quickly obtain the necessary publications and copyright fees are paid.
- Reviewing publications: What studies are valid and which studies were conducted prior to Good Laboratory Practices? Do the studies meet FDA’s “core standards”? Do human adverse events reports have the same scientific rigor as animal studies? Burdock Group has full-time experienced toxicologists on site at our brick and mortar office, trained to drill down on this information in an unbiased manner — ruling out some reports of studies as having not been conducted or the results evaluated in a manner to be considered to be an unbiased assessment of the facts.
- Writing a persuasive assessment of the facts: The Food and Drug Administration has repeatedly stated that any successful submission is more than a collation of documents and a narrative describing why the petitioner would like a favorable response. For a successful submission, the petitioner must meet the “burden of proof” as well as the “burden of persuasion.” The burden of proof involves a thorough discussion of all of the evidence: direct, indirect and antithetical — no cherry-picking the data for favorable information. However, even at this level of skill in research and presentation, there remains a good deal of subjectivity in the approval process. Therefore, because the “facts cannot always speak for themselves” the petitioner must also meet the burden of persuasion and, at Burdock Group, we have experienced considerable success by crafting a persuasive document which we believe provides the final level of comfort to the expert panelist or the regulator and augurs for approval.
Do these processes in preparing for a successful interaction with a regulatory agency constitute a “Cadillac®” or a “Ford®” type of product? Neither, the metaphor is wrong and should address the degree of risk you are willing to tolerate. Whatever type of metaphorical model car you want it to be (Cadillac® or Ford®), it needs to be “bullet-proof” and only Burdock Group has the infrastructure, personnel and experience to provide you with the best protection. There are no bargains in consulting, only the degree of risk you are willing to tolerate and as the saying goes: “you get what you pay for.”Tags: consulting, FDA, GRAS, marketing, regulatory compliance