Onset of FSMA to drive continued demand for consulting services, expert says

By Hank Schultz contact

- Last updated on GMT

Related tags: Food and drug administration

FSMA to drive demand for consulting services
The demand for consulting services will only continue to rise as new laws come into full implementation, said a consulting company executive.

Dean Cirotta, president and COO of EAS Consulting Services, gave NutraIngredients-USA a brief look at teh market on the occasion of EAS taking over the client list of longtime consulting firm Phoenix Consulting, whose founders are retiring.

“I do think regulatory consulting is still a growing opportunity,” Cirotta said. “FDA continues to enforce DSHEA. We see a stream of warning letters.”

EAS is known for having one of the largest and most experienced consultant networks in the industry, with approximately 150 technical experts in the areas of foods, pharmaceuticals, dietary supplements, medical devices, biologics, cosmetics and tobacco. Many additional consultants who had previously worked with Phoenix clients are now joining EAS ranks, expanding that expert network even further.

“One of the unique things about our company is that we have experts in all of the FDA regulated industries,” ​Cirotta said.

GMP onset still reverberates

When the GMPs first started to be implemented in 2008, there was some push-back in the industry concerning how expensive and labyrinthine the rules would be in practice, and how they might place a particular burden on the smallest companies, those with 50 or fewer employees, which were supposed to be in compliance starting in 2010.  EAS has worked with a number of such companies, and lone of EAS’s consultants, Tara Crouch, said she’s sensitive to those concerns, but believes its just common good sense and good business practice to be able to know and to be able to prove that you can make a product the same way every time.  

Nevertheless, it can be costly implementing the required quality control procedures, especially in smaller companies that may have had a more seat-of-the-pants approach in the past. Some of these companies that have had reputations for quality within the industry have received warning letters because they couldn’t prove the reproducibility or robustness of that quality in a way that satisfied regulators. Trying to help companies get that done without breaking the bank is where Crouch comes in.

“Establishing that quality backbone is very challenging, but it can be done. It is costly so you have to figure out how to do it wisely,”​ she said.

Cirotta said that the advent of rules stemming from the Food Safety Modernization Act (FSMA) will have profound effect on the supply chains of the dietary supplement industry.  Of particular note is the Foreign Supplier Verification Program.

“Those who are importing dietary ingredients will have to be aware of FSMA. With FSMA we see a lot of opportunity for consulting services growth,”​ he said.

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1 comment

Cost Efficient Compliance?

Posted by Brandon Griffin - Ingredient Identity,

Definitely possible if structured right. Just as the mantra of "transparency" is being pushed throughout the industry as of recent, so should the accountability of experts in this industry who consult on such things. Small companies are encouraged to understand their regulatory requirements based on their business model and we help them to budget accordingly, well before starting in on such regulatory consulting work especially if they have never been involved in such areas or are facing a regulatory action for the first time. It is important to educate and identify risks upfront, help them set priorities, etc. so all options are on the table, including the possibility of changing their business model to alleviate certain regulatory burdens. We've seen other firms start taking a more aggressive and fear mongering approach as a result of increased enforcement and FSMA...however, such is a low talent way of drumming up business given the already rising tide of regulatory enforcement in our industry. Nonetheless, the cost of getting caught up in a lawsuit or regulatory actions as a result of some quality or compliance issue, easily trumps the expense of leveraging experts to make sure the right systems are in place and working optimally.

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