Tougher FDA, Congressional “Meddling” With DSHEA Likely In 2013

Compliance with GMPs and other components of DSHEA is not a priority for some firms marketing supplements in the U.S., says contract manufacturing executive Mark Le Doux. “Warning letters … keep pouring out because [firms] either didn’t read the law or they didn’t think they’d be discovered,” he says.

Congressional “meddling” with dietary supplement regulations, including the emergence of debate over a pre-market approval process, is likely in 2013, according to manufacturing executive Mark Le Doux.

Continued reports of manufacturers failing to comply with the Dietary Supplement Health and Education Act, and an increase in enforcement from FDA, are likely to drive interest from members of Congress in amending the act, he said.

Le Doux, chairman and CEO of [Natural Alternatives International Inc.], talked of potential changes for the industry at SupplySide West in Las Vegas Nov. 8.

Stakeholders should expect FDA to ratchet up good manufacturing practice inspections, he said.

“Now the election is out of the way and things are status quo, FDA is going to get a lot more tough,” Le Doux said. The agency is “done with basic GMP evaluations.”

He estimated San Marcos, Calif.-based NAI has spent $8 million over the past five years in facility improvements, on more efficient equipment and on training in order to achieve compliance with DSHEA-imposed regulations FDA establishes and enforces. NAI provides contract manufacturing and product formulation services.

However, compliance with GMPs, new dietary ingredient notifications, claims substantiation and other DSHEA components is not a priority for some firms marketing supplements in the U.S., Le Doux said. “Warning letters … keep pouring out because [firms] either didn’t read the law or they didn’t think they’d be discovered,” he added.

And with FDA inspection activity increasing in the third year since the GMP final rule became effective for all firms, more reports can be expected of violations by manufacturers and ingredient suppliers. “FDA isn’t playing games anymore,” Le Doux said.

Sen. Dick Durbin is a likely author of legislation to change DSHEA. The Illinois Democrat, a frequent critic of FDA’s regulation of the supplement industry, in 2011 introduced the Dietary Supplement Labeling Act, S. 1310, to clarify how products should be regulated as foods or supplements, which he said have a "less stringent safety standard." Durbin also has led the charge on asking FDA for more GMP enforcement (Also see "FDA Works To Clarify Supplement/Food Distinction In Durbin Response" - Pink Sheet, 3 Sep, 2012.).

Le Doux expects FDA to tighten enforcement on supplement firms’ supply chain records because manufacturers commonly use ingredients from international suppliers. A supply chain that touches markets outside the U.S. likely draws higher scrutiny from FDA, he said, suggesting that firms tighten their recordkeeping and ensure they validate internal testing audits.

“FDA isn’t going to give you a hall pass because it’s too far to go to South Africa to check the raw materials facility. If you’re using it in finished product, you … should be testing it or get someone down there that knows how to audit a facility,” Le Doux said.

User Fees As Bargaining Chips

Le Doux also says lawmakers could propose additional user fees for supplement firms as bargaining chips in negotiations to avert the “fiscal cliff” of automatic spending cuts across federal agencies slated to start Jan. 2 (Also see "FDA Taking “Risk-Based Approach” To Sequestration Cuts" - Pink Sheet, 15 Oct, 2012.).

Supplement and food product manufacturers already are subject to user fees for facility or import re-inspections and mandatory recalls under the Food Safety Modernization Act (Also see "In Brief" - Pink Sheet, 6 Aug, 2012.).

Adding an annual fee for a manufacturing facility, however, might appear attractive to House and Senate members looking to cut spending on federal agency budgets. The fees would help defray FDA’s costs for regulating the industry.

“For those firms that are compliant, it would only seem logical that a reasonable user fee might be on the table,” Le Doux said.

He also suggested that to help defray their costs, manufacturers form consortiums for hiring third-party auditors to inspect each firm’s facility. “A drive-by will not get it done. There must be a complete audit and report,” Le Doux said.

FDA officials have endorsed the sharing of supplier audit reports among firms in part to help firms cut GMP compliance costs, and the Standardized Information on Dietary Ingredients Work Group industry coalition this year issued a pocket guide for qualifying ingredient suppliers (Also see "Supplier Qualification Guideline Touts Flexibility, Defers Best Practices" - Pink Sheet, 23 Apr, 2012.).

Incentivize Supplement Research

Supplement firms can see the importance of research to back up claims for their products in the National Advertising Division’s continued attention to nutritional product advertising claims, in addition to the Federal Trade Commission’s advertising regulations enforcement and FDA’s monitoring of supplement claims.

But on the other hand, there is ample disincentive for firms not to pay for the research, Le Doux said.

Supplement firms “have spent millions of dollars in fundamental research bringing branded raw materials to the party, and within 20 minutes someone else knocks it off and sells it at half price,” Le Doux said.

“Why would they create an entire benefit so someone else can rip it off? That’s got to change.”

With stronger intellectual property rights available for supplement ingredients, the threat of knock-offs would decrease and more firms likely would invest in research.