The American Herbal Products Association’s comments are a blend of suggestions to streamline GMPs for foods and supplements as well as ways to ameliorate the potential impact of the Food Safety Modernization Act on firms that harvest and process botanical ingredients. The suggestions put forth by the Council for Responsible Nutrition were more proscribed, and focused on suggested tweaks to electronic record keeping and auditing of suppliers (both parts of 21 CFR Part 111) and an improvement in the export certificates supplied by FDA’s Center for Food Safety and Applied Nutrition (CFSAN).
The actions taken by the trade groups are in response to a notice and request for information placed on the federal docket in early March by the Office of Policy and Strategic Planning within the Commerce Department. The notice, titled Impact of Federal Regulations on Domestic Manufacturing, was posted in response to a memo from the Trump Administration January that directed federal agencies to find ways to streamline regulations for domestic manufacturers.
Improve the export certificates
One of the biggest aspects of CRN’s comments was in fact not a suggestion for a streamlining or elimination of duplicative regulations per se. Rather, CRN was suggesting changes to the export certificates that are currently applied to products made in the U.S. that could give a better picture of the true quality of those products.
“It is something that CRN has been trying to speak to Commerce and FDA about for a while,” said Duffy MacKay, senior vice president of scientific and regulatory affairs for CRN. “These are really important documents for some foreign governments.”
The export certificates are required by certain foreign governments but MacKay said the certificates as they stand are too rudimentary to supply a lot of the information these governments are looking for. MacKay said exporters get around this by supplying the requested information in various ways, but the process is unnecessarily complicated and time consuming. CRN suggests that the certificates be issued in pre-notarized form and already emblazoned with seals (two things many foreign jurisdictions want to see) and contain certain key phrases such as “Food for human consumption” and “Freely sold in the U.S.A.” In addition, CRN suggested that the certificates include enough space to adequately describe the GMP compliance of the manufacturer. MacKay said that is a big selling point for U.S. products overseas.
“We are really proud of our dietary supplement GMPs and they are some of the best in the world. Our GMPs are help up overseas as an example, and the fact that FDA is actively inspecting facilities is an important selling point. Some of that is lost in the documents when products are exported. Companies have relied on additional certificates from state governments or local chambers of commerce,” MacKay said.
CRN also suggested striking a requirement that computer systems used by dietary supplement manufacturers be validated to a rigorous standard taken from the pharmaceutical realm to prove that the systems are secure and reliable. The validation process is difficult and expensive and, as software developers frequently issue updates to their products, it can be confusing, too. Does every new patch require a new cycle of validation? This burdensome requirement has led many supplement manufacturers to continue to rely on paper records, MacKay said. CRN also suggested that wastewater handling requirements more closely reflect the relatively benign chemicals used by most dietary supplement manufacturers. In addition, CRN suggested a tweak to the rule for how companies must verify their suppliers to give flexibility as to how this is done. This would give companies the green light to devote more time to riskier situations and devote less time to suppliers that have been proven to be reliable and low risk.
AHPA: FSMA misconstrues nature of botanical suppliers
The comments submitted by AHPA reflect observations the organization has previously made on certain definitions that were inserted into regulations pertaining to FSMA (Part 117). In its comments, AHPA said that the way these FSMA rules define food manufacturing could shift many farms and wildcrafting operations that supply dried botanical raw agricultural commodities (RACs) into the same category as companies that manufacture processed food. This would impose regulatory requirements on these operations, many of which are small, that would be both burdensome and unnecessary. Drying a botanical commodity and briefly heating it for sterilization should not be placed in the same hopper as full blown food processing steps, AHPA maintained.
“In promulgating the implementing regulations for FSMA, FDA has defined ‘manufacturing/processing’ very broadly and ‘farm’ very narrowly.As a result, numerous activities that farms normally use to prepare a food crop for trade as a RAC are now activities that transform the crop into a ‘processed food’ and are therefore subject to food facility registration and food GMPs,” AHPA’s comments stated.
Continuing on in the FSMA vein, AHPA suggested that the requirement for companies to annually obtain “written assurances” of regulatory compliance from vendors would amount to a blizzard of mostly useless paper. The Grocery Manufacturers Association had concluded that this could potentially result in millions of assurances being passed around every year, and under the Obama Administration this requirement was de facto suspended. AHPA suggested that this suspension be made permanent.
Small business exemptions
In commenting on how dietary supplement GMPs might be streamlined, AHPA suggested that specific small business exemptions be put into place for Part 111, as was done with Part 117. AHPA president Michael McGuffin said in 2010 (the year that GMPs became effective for the smallest tier of the dietary supplement industry) that Part 111 would put some small companies out of business or would compel them to resort to contract manufacturers. This has now come to pass, AHPA comments stated. AHPA noted that FDA estimated when Part 111 was put into place that compliance costs for the smallest business tier would average $46,000 annually. AHPA believed that was a low ball figure even in 2005, and costs have ballooned since then.
“AHPA is aware of a number of small firms that have been driven out of business, or forced to outsource their manufacturing, as a direct result of this rule. Since many of the affected businesses are located in rural areas or small towns, this can represent significant job losses in economically depressed areas,” AHPA comments stated.
Dump the NDI guidance
Other comments by the group included accepting the use of batch production records to vouch for the compliance of a given lot of material. AHPA also called for the rationalization of rules on pesticide residues. Current pesticide residue policies reflect the world of the 1970s, the group’s comments state, and don’t match well with the modern global marketplace. AHPA also took this opportunity to swing for the fences, so to speak, and reiterate its call for the New Dietary Ingredient draft guidance to either be substantially revised or withdrawn altogether.
“The existence of the 2016 draft guidance is highly misleading to the regulated industry and its negative impacts are already being felt on dietary ingredient and supplement manufacturers. Therefore, in view of its severe inconsistency with the statute, it should be immediately either significantly revised or completely withdrawn,” AHPA comments state.