Ingredient Specs Vital Under Both Supplement GMPs And FSMA Regs

Establishing and testing for ingredient specifications are a crucial part of dietary supplement good manufacturing practices, and likely will be under the food safety preventive controls rule once that regulation is finalized, FDA’s Daniel Fabricant says.

Specifications must be set to account for an ingredient’s origins and lifecycle whether the ingredient is subject to dietary supplement good manufacturing practices or pending Food Safety Modernization Act regulations, says Daniel Fabricant, FDA Division of Dietary Supplement Programs director.

At the Food & Drug Law Institute’s Safeguarding the Functional Food and Dietary Ingredient Supply Chain Conference Sept. 10, Fabricant said botanical ingredients should have specs for heavy metal and pesticide levels under the 2007 supplement GMPs final rule as well as the food safety preventive controls regulation, currently in proposed rule form (Also see "Convoluted Herbal Requirements Foretell FSMA Complexities" - Pink Sheet, 16 Sep, 2013.).

“For those folks who aren’t meeting the basic tenets of GMPs, people who don’t set specs for dietary supplements, there’s not a lot we can do,” Fabricant told the FDLI audience. “I imagine the same will be true for preventive controls.”

FDA’s recently posted supplement GMP warning letters, below, show the industry’s continuing struggles with establishing and testing for ingredient and product specifications.

Recipient	Warning Letter Date	Inspection Dates	Warning Letter Highlights
Irenda Corp. (Los Angeles)	April 15, 2013	Sept. 12-14 & 17, 2012	Irenda “failed to confirm the identity of other components (not including dietary ingredients) of your L-Carnitine products and failed to determine whether other component specifications … were met, by either conducting appropriate tests or examinations, or relying on a certificate of analysis from a qualified supplier of the component. … Your firm has not qualified any supplier’s COAs. Specifically, you used the COAs from your suppliers for components glycerin, potassium hydroxide, and citric acid in the manufacture of the products Co-Q10 L-Carnitine, Acetyl L-Carnitine, and L-Carnitine, but failed to establish the reliability of the suppliers’ COAs through confirmation of the results of the suppliers’ tests or examinations.”
Sundial Herbal Products (Bronx, N.Y.)	May 24, 2013	Oct. 4 – Nov. 15, 2012	Sundial, the maker of Woman Back Tonic and Koromantee products, “did not implement quality control operations in your manufacturing, packaging, labeling, and holding operations. … Your equipment or utensils are not maintained to protect components and dietary supplements from being contaminated. … Specifically, the oak barrels used to hold tonic components and finished products are not dedicated for storing particular components or tonics, and cannot be sanitized between uses; this creates the potential for components and/or finished dietary supplement products to become contaminated with prior contents and/or microorganisms.”
Precise Nutrition International Inc. (Indio, Calif.)	July 11, 2013	Dec. 10-21, 2012	Precise “failed to establish specifications for any of the components used in your VitalErotic Shot dietary supplement product, including dietary ingredients L-arginine HCL, L-ornithine HCL, gamma amino butyric acid, yohimbine HCL, ascorbic acid, thiamin HCL, niacin, pyridoxine, and cyanocobalamine. … Additionally, your firm did not have a specification for the length of time bulk dietary supplement liquid can be stored in (redacted) containers prior to filling. Your filling operations for VitalErotic Shot did not immediately follow your blending operations. Bulk dietary supplement liquid was observed to be stored in these containers from 11 days to 199 days between blending and filling. You did not have a specification for the length of time bulk dietary supplement liquid will continue to meet finished product specifications after this storage period.”
Lumina Health Products Inc. (Sarasota, Fla.)	Aug. 1, 2013	Nov. 26-30, 2012	Lumina, which makes CellFood products, responded to FDA Dec. 13, 2012. “In your response, you provided a copy of a written procedure entitled ‘Product Receipt, Warehousing and Distribution.’ However, the response is inadequate. … You also remarked in your response that ‘neither humidity nor lighting – in all forms – have any effect on the composition or efficacy of the products, and are therefore not measured’ and identified the ‘prescribed range of temperature [of holding products] between (redacted) and (redacted).’ Please provide a basis on why humidity and lighting do not affect the composition or efficacy of the products and why the basis of the temperature range is acceptable and do not affect product quality.”
Y.S. Health Corp. (Mt. Prospect, Ill.)	Aug. 29, 2013	Dec. 6, 2012 – Jan. 30, 2013	Y.S. Health responded to FDA Feb. 15, 2013. “Your response included [a master manufacturing record] for your HiBee Royal 1500 (150 capsule) dietary supplement product. However, this MMR is deficient with respect to the labeling and packaging operations you perform. … Your record references ‘yield’ specifications but fails to list what the specifications are. … Your record fails to provide written instructions on corrective action plans for use when a specification is not met.”
Brower Enterprises (Canton, S.D.)	Sept. 9, 2013	Dec. 4, 6, 7, 2012	Because Brower receives “certain products from a supplier for packaging or labeling as a dietary supplement (and for distribution rather than return to the supplier), you must establish specifications to provide sufficient assurance that the product you receive is adequately identified and is consistent with your purchase order. … However, your firm did not establish specifications for Myristoleate PLUS Cetyl Myristoleate that you received from the manufacturer. … In your response dated Jan. 7, 2013, you stated that as of Dec. 5, 2012, you would no longer be labeling any products at your facility. Your firm also did not establish specifications for the WOW product that you received from the distributer for relabeling. As noted above, during our inspection you agreed to recall and cease distributing your WOW product,” which FDA found to be an unapproved new drug.