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Michael A. Colodney advises clients on the regulatory and legal issues involved with the development, manufacture and marketing of FDA regulated products such as foods & food additives, dietary supplements, pharmaceuticals and cosmetics.
Mr. Colodney served as General Counsel to several companies marketing dietary supplements, and was lead attorney on the product launches of TRIMSPA® X32 and WINFUEL™. He brings the experience of being General Counsel for the company marketing the number one dietary supplement in its category. This experience helped him develop the philosophy of taking aggressive but defensible positions with regards to claims in labeling and advertising.
Mr. Colodney advises clients regarding:
- Advertising
- “Before & After” Advertising
- Bringing a product to market
- Claim Substantiation
- Clinical Study Agreements
- Distribution Agreements & Issues
- Dietary Supplement Health and Education Act
- FDA Compliance
- Food, Drug & Cosmetic Act
- FTC Issues
- Generally Recognized as Safe substances
- Good Manufacturing Practices
- Health Claims
- Labeling & Packaging
- Manufacturing Agreements
- New Dietary Ingredients
- Product Liability
- Raw Materials Supply Agreements
- Reasonable Scientific Evidence
- Structure and Function Claims
- Testimonials
- “Traditional Use” Substantiation
- 30 day pre-market notices
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