Nutritional science for mind health products
DSM Nutritional Products
AHPA submitted a petition for reconsideration to the US Food & Drug Administration (FDA) requesting the agency amend seven specific elements in the final rule as it was published on June 25, 2007.
The association said the points in question are potentially confusing, contrary to the public interest, or detrimental to manufacturers with no corresponding benefit.
A statute of the 1994 Dietary Supplements Health and Education Act (DSHEA), GMP legislation has been the missing link in governance of the dietary supplement industry. The legislation is set to provide standards specific to this industry for inspectors to check for purity, safety and legality in manufacturing.
The new GMPs put the burden solely on the manufacturer, meaning there may now be increased pressure from these very manufacturers on what they expect of their suppliers.
Those companies with more than 500 employees will have until June 2008 to comply, while those companies with less than 500 employees have until June 2009 to comply. Finally, those with fewer than 20 employees have until June 2010 to comply with the regulations.
Dietary supplement trade associations have been involved in the process of bringing GMPs to life, insofar as providing comments and input to FDA. While many were nervous as to what the regulations would look like when finally issued, it appears that overall they have been met with approval. AHPA has underscored it approves of the general document, but has found room for fine-tuning on the part of the federal agency.
According to AHPA, its petition was submitted under an FDA rule that applies the Administrative Procedures Act to all federal agencies, giving "an interested person the right to petition for issuance, amendment, or repeal of a rule." Any decision to accept or reject such a petition will be at the FDA Commissioner's discretion.
AHPA's petition to requests that FDA:
-Clarify that a dietary ingredient manufacturer or supplier cannot be made subject to the final rule based on how its customers use its ingredients.
-Remove a potential loophole that would allow companies that package products made by someone else to avoid some parts of the rules on verifying that product specification are met.
-Add definitions for the terms "manufacturing," "packaging," "labeling," and "holding."
-Allow master manufacturing records to include a range of batch sizes, rather than be limited to a specific batch size.
-Remove language that would have the effect of barring any single-employee companies from being in the dietary supplement business, and replace it with appropriate options that will ensure product quality even in such small firms.
-Allow personnel to conduct examinations for correct labels (this is now limited to electronic or electromechanical examination) to qualify for an exemption to label reconciliation.
-Require that the batch, lot or control number that must be assigned to dietary supplements actually appears on finished products.
"AHPA believes that these are all reasonable requests and hopes that FDA accepts them as such," said AHPA president, Michael McGuffin.