14.2

GPM regulations apply to?

- All domestic & foreign companies that manufacture, package, label, or sell dietary supplements in the US - Rules for dietary supplements were established starting in June 2008 - June 2010

Regulations require for dietary supplements

- Dietary supplements be processed consistently to MAINTAIN IDENTITY, PURITY, STRENGHT, & COMPOSITION, that they meet quality standards, & that the products are ACCURATELY LABELED

Supplement Facts Requirements

- Dietary supplements must contain the SAME LABEL INFORMATION that is required for all FOOD PRODUCTS sold in the US

FDA regulations for GPMs are designed to help?

- Ensure that all pharmaceuticals & dietary supplements are manufactured with controls in place that result in consistent products that are free from contamination

Product Identification Requirements

- FDA require all dietary supplement labels to include, at a minimum, 4 COMPONENGT TO IDENTIFY THE PRODUCT PACKAGED in the container: 1. The NAME OF THE PRODUCT with an indication it is to be used as a supplement 2. QTY contained in the package 3. DIRECTIONS for use 4. Name & location of the MANUFACTURER

Personal Qualifications

- Include employing QUALIFIED employees & supervisors

Recordkeeping

- Includes ESTABLISHING & USING MASTER MANUFACTURING & BATCH PRODUCTION RECORDS, & retaining all manufacturing records

Complaint Handling

- Includes KEEPING A WRITTEN RECORD OF EACH PRODUCT COMPLAINT related to current GMPs

Process Verification

- Includes establishing procedures for QUALITY CONTROL OPERATIONS

Sanitation & Cleanliness

- Includes holding & distributing dietary supplements & materials used to manufacture dietary supplements under APPROPRIATE CONDITIONS OF TEMPERATURE, HUMIDITY, LIGHT, & SANITATION so that the quality of the dietary supplement is not affected, & designing & constructing manufacturing plants in a manner that protects dietary ingredients from becoming ADULTERED (made impure by the addition of an inferior ingredient) during manufacturing, packaging, labeling, & holding

Equipment Verification

- Includes using EQUIPMENT & UTENSILS that are of appropriate design, construction, & workmanship for the INTENDED USE

Regulations for GPM adress

- Recordkeeping; Personnel Qualifications; Sanitation & Cleanliness; Equipment Verification; Process Validation; Complaint Handling

US FDA

- Responsible for OVERSIGHT & ENFORCEMENT of current Good Manufacturing Practices (GMP) for dietary supplements

Categories for labeling requirements

- Supplement facts requirements; Product identification requirements; Other information (not required by the FDA)

Labeling must state the following under the supplement fact portion of the labels

1. Serving size & qty in a serving 2. Dietary components listed in the following order: - Ingdts w/ established daily standards (protein, CHO, & Vits) should appear 1st - Ingdts w/out established daily intake appear next on the label - Botanicals must be listed based on the most commonly accepted botanical name & include the part of the plant used - Blends of ingdts must be listed by total wt & components must be listed in descending order of contribution to the total 3. The last components to be listed are non-dietary ingdts (fillers). They must be listed in descending order by wt of contribution to to the total

Other Information (not required by the FDA)

1. Side effects, contraindications, &/or duration of use 2. Statements regarding FDA approval of the manufacturing facility 3. Contact phone # &/or website 4. Food allergy information 5. Products storage information 6. Product lot number & expiration date