FSN 436 Lecture Notes - Lecture 10: Dietary Supplement Health And Education Act Of 1994, Dietary Supplement, Serious Adverse Event
13 Jan 2017
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Department
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Professor
• Dietary Supplements
• Definition
• Where found in Federal Regulations
– Dietary Supplement Health & Education Act (DSHEA) 1994
– Podut take oall that otais a dieta igediet iteded to suppleet the
diet
– http://www.fda.gov/Food/DietarySupplements/default.htm
• Dietary Supplements
• Dietary Ingredients
– Vitamin
– Mineral
– Herb or other botanical
– Amino Acid
– Enzymes
– Organ tissues
– Glandulars
– Metabolites
– Extracts or concentrates
– Dietary Supplements
• New Dietary Ingredient
– Dietary ingredient not sold in the U.S. in a dietary supplement before 10-15-94.
• Dietary Supplements
• DSHEA
– I a speial atego ude geeal uella of foods, ot dugs
– Every supplement must be labeled a dietary supplement
– Dietary Supplements
• What do you think is the largest category of dietary supplements?
• Do you take a dietary supplement?
• Dietary Supplements
find more resources at oneclass.com
find more resources at oneclass.com
• DSHEA amended the FFDCA
• How were dietary supplements regulated prior to DSHEA?
– As other foods
• DSHEA
• What is the responsibility of firm selling the dietary supplement?
– Safety
– Claims made are substantiated by adequate evidence that they are not false or
misleading
– Do not need approval before marketing
– Exception is for a new dietary ingredient –pre-market review for safety data & other
information is required
• DSHEA
• What is missing?
– No minimum standard of practice for manufacturing
– To issue GMPs that focus on
• Identity
• Purity
• Quality
• Strength
• Composition
– DSHEA
• Prior to DSHEA were regulated under cGMPs for food
• 2003 proposed cGMPs for dietary supplements
• FDA issued final rule June 25, 2007
– 200 pages in Federal Register
• Two contentious points
– FDA assertion of rights to inspect cGMP records
– “iilait of ule’s to GMPs fo dugs
• DSHEA
find more resources at oneclass.com
find more resources at oneclass.com
• Highlights of cGMPs for dietary supplements
– Sanitation measures –same as cGMPs for food
– Avoidance of contamination –same as cGMPs for food
– Written procedures relating to equipment, QC, labeling ,etc
– Production and process control system specifications
– Certificates of analysis/testing incoming ingredients
– Batch testing –appropriate statistical sampling
– ID and quarantine of returned dietary supplements
– Product investigation product complaints –failure of cGMPs
– Record maintenance
– etc
• DSHEA
• FDA response to two points of concern
– There are special cGMPs for specific categories of food -Can you provide two
examples?
– Dietary supplement cGMPs resemble drug cGMPs because of similar issues based on
dosage forms –different than for food
– http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInforma
tion/DietarySupplements/ucm238182.htm
• DSHEA
• Issue of mandatory inspection of cGMPs records
– FDA’s positio
• FDCA Section 402(g) & 701(a)
– Can promulgate regulations for efficient enforcement of the Act
– Ho does this diffe fo FDA’s uet positio ith egads to
cGMPs for food processors
– DSHEA
• Notification to FDA
– Market dieta suppleet ith e dieta igediet
find more resources at oneclass.com
find more resources at oneclass.com
Document Summary
Dietary supplements, definition, where found in federal regulations. Dietary supplement health & education act (dshea) 1994. P(cid:396)odu(cid:272)t take(cid:374) o(cid:396)all(cid:455) that (cid:272)o(cid:374)tai(cid:374)s a (cid:862)dieta(cid:396)(cid:455) i(cid:374)g(cid:396)edie(cid:374)t(cid:863) i(cid:374)te(cid:374)ded to supple(cid:373)e(cid:374)t the diet. Dietary ingredient not sold in the u. s. in a dietary supplement before 10-15-94: dietary supplements, dshea. I(cid:374) a spe(cid:272)ial (cid:272)atego(cid:396)(cid:455) u(cid:374)de(cid:396) ge(cid:374)e(cid:396)al u(cid:373)(cid:271)(cid:396)ella of (cid:862)foods(cid:863), (cid:374)ot d(cid:396)ugs. Every supplement must be labeled a dietary supplement. Claims made are substantiated by adequate evidence that they are not false or misleading. No minimum standard of practice for manufacturing. Dshea: prior to dshea were regulated under cgmps for food, 2003 proposed cgmps for dietary supplements. Fda assertion of rights to inspect cgmp records. I(cid:373)ila(cid:396)it(cid:455) of (cid:396)ule"s to (cid:272)gmps fo(cid:396) d(cid:396)ugs: dshea, highlights of cgmps for dietary supplements. Sanitation measures same as cgmps for food. Avoidance of contamination same as cgmps for food. Written procedures relating to equipment, qc, labeling ,etc. Product investigation product complaints failure of cgmps.
