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When Can a Supplement Manufacturer Claim to be an FDA Compliant Facility?

by | Jul 26, 2017 | Diet Pills | 0 comments

At the most basic level, a supplement manufacturer can claim to be an FDA compliant facility when it has complied with all the legal requirements placed upon them by the U.S. Food and Drug Administration. For a dietary supplement, such as many nonprescription diet pills, the FDA requires certain steps to be taken.

Dietary supplement manufacturers must begin their operation by registering registering with the Food and Drug Administration as their first step toward running an FDA compliant facility. This involves submitting certain information about the location and contact information about the facility as well as what it will produce and that the FDA can send personnel to the facility in order to inspect it and determine that it meets certain regulatory standards.

Those regulatory standards are laid out in the guidelines of the current good manufacturing practice (cGMP) as described in the Code of Federal Regulations (CFR) Title 21(111). This is a requirement regardless of whether the facility manufactures for its own company or for a product that will be labeled and packaged by another person or company. As long as the end product is meant to be distributed and sold in the United States, an FDA compliant facility must also adhere to the regulations laid out in the cGMP guidelines.

Dietary supplement companies will frequently add various types of seal or symbol on their product packages or labels which say things like “FDA Approved Facility,” “Certified GMP,” or “cGMP Inspected Facility.” Currently, there is no official seal or stamp used by the FDA for this purpose and the misuse of the FDA’s logo is an illegal practice. It is important to note that while manufacturer may be inspected by skilled FDA employees and pass the cGMP requirements, the FDA does not issue an approval or certification seal of this achievement.

It is important to point out that this registration and inspection process applies only to the facility and manufacturing practices. The FDA does not have an approval process for the dietary supplements themselves. While the cGMP guidelines require that practices meet certain standards and finished products be tested to avoid the risk of possible tainting, contamination or ingredients mix-up, the goal is to ensure that what is on the label reflects what is in the supplement.

It is up to the product manufacturer or distributor to make certain that the product they sell to companies or consumers is safe and lives up to its marketing claims.

Sources:
https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/FoodDefense/ucm331957.htm
https://www.fda.gov/drugs/developmentapprovalprocess/manufacturing/ucm169105.htm
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=111&showFR=1

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