Editorial: Issues Dialogue Heats Up - GMPs and More

Just finished a busy but stimulating week.

In fact, in the course, of, I saw many of you as I went from the UNPA GMP II seminar in Salt Lake City, on to the Annual CRN conference in New Mexico.

I’ve now had at least a bit of time to digest some of the findings and implications from the former.

I’m going to assume, for better or for worse, that most of you reading this column have at least a passing familiarity with the supplement GMP’s, made into law in 2007, called for within DSHEA (1994), and for which the first compliance date (June 2008 for large companies) has already passed. Perhaps, and I say this in all seriousness, my assumption above is far too generous, and that far too many in our industry still have not even begun to ask the questions they must, in order to ready themselves and their organizations for upcoming compliance dates 2 (medium) and 3 (small companies).

I always find the UNPA sessions fascinating. First of all, and this time was no exception, the faculty was outstanding. Secondly, the sessions typically have an interesting cross-section of attendees, both geographically and by role in the value chain. This time, as far as value chain role was concerned, the spread was comprehensive; as far as geography was concerned, the participation was highly dominated by Utah-based companies, even more so than usual, possibly a comment on tight calendars and rising travel costs. Finally, the debate rarely shies away from controversy, and once again, attendees were not disappointed.

Session Chair and UNPA Executive Director Loren Israelsen used real-time polling technology for the event, familiar to those of us used to seeing it at the NBJ Summit, but this time, its use was even more ‘real-time’ and spontaneous as Israelsen, and then presenters directed questions on the fly during the day.

Presentation Highlights

An oft-asked question (or at least curiosity) in our industry is ‘what do you get for a buck. This question is based on the fact that one can go down to the dollar store and buy supplements in many categories for as little as one dollar, and in a general observation, realize that in most categories, the pricing spread can be as much as 10 times, frequently leaving a confused consumer quite unsure how to differentiate, a fact that might be even more important in today’s challenged economic climate. Israelsen has presented ‘buck’ data before, but the current project was updated, involved contract lab analysis, and presented some surprising results.

In a general sense, and of course there were exceptions) most of the inexpensive products passed specifications, that is, they met their label claims according to analysis. If they said they contained ‘x’ component, this component was detected. In a few cases, there were label variances, but as noted, many did contain what they said they ought to. One serious implication for the result is the question: “Is this quality?” For instance, if a product contains its ingredient at label level, (or does not state a level, just the presence of) but this level is known to be sub-efficacious, has anyone been misled? Is it reasonable for the FDA/FTC to have any involvement in this type of enforcement?

One of the most interesting presentations of the day was delivered by Brad Williams, from FDA. Both in his actual presentation, and later in the day as he responded to questions from both Israelsen and the audience, Williams exhibited an open, practical, communicative position regarding FDA ‘s GMP enforcement, suggesting that a consultative inspection and feedback process was not only feasible, but desired by much of the agency. It emerged in his presentation that one of the initial inspections under the supplement GMPs had turned adversarial (for reasons unclear) and it was quite clear that this occurrence was disturbing to Mr. Williams.

Among the points raised by Mr. Williams was the observation that while GMPs will allow the detection of expected adulterants, they will not detect unexpected adulterants. At about this time, a couple points were raised, first of all that the agency was interested in suggestions from industry as to what adulterants might be consistently being introduced into certain product classes, and most significantly, melamine would not be considered, in most cases, an expected adulterant. In a related observation, attendees were asked whether they were currently testing for melamine, with less than 20 percent replying affirmative.

Mr. Williams, both during the presentation, and at the conclusion of the day, fielded a number of questions, some specific, some general, making a few ‘observations’ and recommendations’ along the way, This included advice to test for melamine if appropriate, for manufacturers to work closely with ingredient companies to establish both specifications and test methods, and in a surprise spot questioning of attendees, determined that as many as 45 percent may consider using the petition process to get rid of the obligation of 100 percent identity testing for ingredients. Williams advised that if you don’t know the pedigree of the product, or of your actual ingredient supplier does not know or will not provide it, then it’s time to change suppliers.

So just where is FDA? According to Mr. Williams, an initial train the trainer program has been completed (a second set of sessions are planned next spring prior to the June ready date for mid-size company compliance). FDA work planning now includes DS inspections, and new guidance and other documents are in development.

A number of questions and dialogue related to expiry dating, with debates among audience and faculty. This obviously is an area that still needs more clarification, as while the regulations do not require expiry dating, if a manufacturer knows that the product will degrade over a period of time, and their label includes identifying a marker or component subject to this degradation, and since labeling laws require that a product meet label amounts….. well, one can see the challenges facing supplement manufacturers as they try to determine exactly what to put on their labels. Any expiry date offered, however, must be based on facts.

The next presentation of the day was by Congressman Jim Matheson (D-Utah), who in addition to openly stating his desire to give FDA adequate resources, commented primarily on the financial crisis and its general business implications, leading some, including myself, to wonder at the impact of tighter credit, even as companies are facing both expansion and compliance decisions and financial allocations. When the GMPs were initially contemplated, it was argued that some companies could not bear the financial burden. We are starting to see this materialize, as compliance costs for those who have commenced the process are not insignificant. In a tighter credit environment, will this reach a tipping point, causing companies to either exit the market, or say, “wait till they come get me?” We’ll have to wait and see.

As Williams continued his presentation following the congressman’s departure, an interesting point emerged. There are no compendial standards specifically for dietary supplements. The environment and relationship that USP enjoys for drugs is not mirrored in the supplement quality environment, unless one specifically refers to USP in test method identification. Even if USP were to develop a whole series of supplement specific methods, these would not be legally binding and be the methods made mandatory by the FDA (unlike for drugs). Companies would be able to use compendial or other methods proved suitable. This will likely set up an interesting future debate between industry, certifiers, groups such as AOAC, the analytical testing community and USP claiming ‘official’ status.

FDA anticipated, according to Williams, that there are some products that are difficult, if not impossible to test. “The rule does not require you to invent. The rule requires, though, that you must establish identity.” And while inspectors are given analytical basics as part of their training, they are fundamentally not analytical chemists.

In his closing remarks, Williams suggested that FDA is assuming companies are reasonably prepared and that small organizations may need some help. By the end of the day, and judging by questions and feedback, Mr. Williams may have been second-guessing his interpretation of industry readiness I suspect.

In a follow up meeting with Williams, we spoke about the use (abuse) of FDA approved or GMP certified (implying by FDA) and the fact that this practice was misbranding and hence subject to enforcement.

Next on the docket was a presentation by ex-FDA inspectors Shelly Maifarth and Martina LaGrange (there would be later afternoon presentation by Joy Joseph (also a GMP consultant), triggering a lot of discussion over how to handle a GMP inspection. Obviously, FDA would appreciate a consultative approach, whereas the consultants were in general very specific with information and tactics they would or would not use or make available.

Jim Cudahy, President and COO of Sabinsa, (I had toured their facility the day before and spoken with Jim), next spoke about a voluntary compliance initiative that he had explored with an FDA regional office under the small business program. He was able to get an inspector to come down to his facility at no cost and with limited formal process (none written) to tour the facility and review operations to provide feedback and observations. In fact, the inspector requested some SOP’s (to be returned in full at process conclusion) in order to better prepare, and in an eight plus hour session, provided management with invaluable advice, guidance and suggestions on its operations, facilities and processes. What would typically have become adversarial, instead after an hour or so of sounding out, became collaborative and absolutely invaluable, according to Cudahy.

While I would go on for a while about the balance of the day, I’ll stop here for now.

My own reflections will continue to evolve, but what I can say at this time was that I found Williams (FDA) very refreshing, practical and open, that I was seriously frightened by the naïveté and ignorance inherent in industry queries this past week, and that it is evident that June 2009 (and the period immediately following) will be a watershed for the industry.

Selected polling data (courtesy of UNPA):

47% of attendees labeled themselves as manufacturers (n=113)

52% fell into medium size for GMP compliance June 2009 (n=95)

77% did in house testing for raw materials or finished goods (n=100)

90% declare an expiration date (n=99)

56% are third party certified (n=95)

65% audit <10% of raw material vendors (n=84) *

18% currently test for melamine (n=90)

63% feel FDA should be granted recall authority by Congress (n=113)

75% feel the Federal Government should assert federal preemption over Califorina Prop 65 lead levels (n=114)

41% have not conducted a mock GMP inspection at their own or a vendor's facility in the last year (n=97)*

5% felt a high level of confidence in C of A's provided by raw material vendors (n=106). 53% felt low or almost no confidence. **

29% expected to reduce the number of SKUs their company produces (n=100)

69% felt that consumers, in the wake of the economic crisis, will reduce their supplement spend (n=113)

79% felt that in order to speed up a level playing field, industry sohuld inform FDA of clear viotations (n=102)

41% of respondents answered that their warehouse facilities are not tempaerature controlled (n=98)

45% of respondents have not used an outside analytical lab over the past year (n=84)

46% were budgeting between 0 and 10 hours training per person on GMPs (n=85)**

66% have no protocols in place to detect undeclared, but known contaminants such as ginkgo/rutin, saw palmetto/palm oil (n=95) **

91% of those making male performance products do not test for APIs in raw materials (n=69) **

I have noted those results that I find surprising (*) and downright disturbing (**). I'll let you decide for yourself how you feel about industry feelings and behavior, but for this industry to mature into a compliant environment, at least some of these numbers must change.

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