This private blog replaces the earlier archives I had posted on the Internet and includes various memos sent to the clients of the VitaminLawyer.com (now the Vitamin Consultancy). It includes archived copies of memos from 2004 through 2007 and subsequent memos will be posted as they are issued.
Two years ago the FDA promulgated new food safety rules, citing the risks of terrorism and food-carried disease. The time to adopt a formal Food Safety Plan is running...
If you handle food in your facility, you need a written Food Safety Plan. If you contract with a company to manufacture for you, as the label-owner, you must be in a "state of control" which means, you need to know and document that your contract manufacturer has a Food Safety Plan. That's your responsibility according to FDA.
I've prepared a carefully structured Food Safety Plan Format, directly from 21 CFR 117 -- the food safety regulation.
Contact me to obtain your Food Safety Plan: firstname.lastname@example.org
Here is the outline of the Food Safety Plan requirements:
The Regulation says the Plan shall contain the following Contents:
(1) Hazard analysis - § 117.130(a)(2) (2) Preventive controls - § 117.135(b) (3) Supply-chain program - subpart G (4) Recall plan - § 117.139(a) (5) Procedures for monitoring the controls implementation - § 117.145(a)(1); (6) Corrective action - § 117.150(a)(1); and (7) Verification procedures - § 117.165(b).
The Contents of My Food Safety Plan Format
 Status.  Hazard analysis.  Hazard identification.  Hazard evaluation.  Preventive controls.  Process controls.  Food allergen controls.  Sanitation controls.  Supply-chain controls.  Recall plan.  Other controls.  Preventive control management components.  Monitoring.  Corrective actions and corrections.  Verification.  Validation.  Verification of implementation and effectiveness.  Environmental monitoring  Reanalysis.  Requirements: preventive controls qualified individual (PCQI) / qualified auditor.  Implementation records required for this Plan.
CA PROP 65 TIME HAS RUN OUT
If you think you have enough time to get ready for California's new, tougher, Proposition 65 warning rules, you are wrong.
The new rules started a few days ago.
If you think your product does not get into California, think again.
If you think no one will notice, remember that Prop 65 is enforced by a hoard of private lawyers looking to grab fees and penalties from your company.
My experience will strengthen your company! I provide private and confidential, competent electronic professional consulting to my Dietary Supplement and advanced healthcare ("CAM") modality clients, for the purpose of compliance with International, State and Federal (including FTC and FDA) standards for communicating about the advertising and sale of dietary supplements (including medical foods) and/or providing of health care services and information. You should consider my SOP / cGMP Certification Course, allowing start-up and established vitamin companies and practitioners who own their own private labeled products to meet with new FDA procedural regulations.
Among the common claims that can be used on food ("Nutrition Facts") and dietary supplement ("Supplement Facts") labels are three categories of claims that are defined by statute and/or FDA regulations:
Health Claims Nutrient Content Claims Structure/Function Claims
As I've said many times... beneficial formulas are "easy." Lawful and powerful claims are not. Without being able to persuasively explain the benefit, even the best formula will not sell.
"Health Claims" describe a relationship between a food substance (a food, food component, or dietary supplement ingredient), and reduced risk of a disease or health-related condition. They require prior FDA approval.
Nutrient Content Claims
"The Nutrition Labeling and Education Act of 1990 (NLEA) permits the use of label claims that characterize the level of a nutrient in a food (i.e., nutrient content claims) if they have been authorized by FDA and are made in accordance with FDA's authorizing regulations."
Structure/Function Claims and Related Dietary Supplement Claims
"The Dietary Supplement Health and Education Act of 1994 (DSHEA) established some special regulatory requirements and procedures for using structure/function claims and two related types of dietary supplement labeling claims, claims of general well-being and claims related to a nutrient deficiency disease.'
When you need to find your way through the bureaucratic maze that is claim-making, remember the Vitamin Consultancy... we are here to help!
New FDA Guidance
FDA tells live probiotic product makers how to label their products.