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Medical Food Draft Guidance – Has the FDA Bitten Off More than it Can Chew?
December 18, 2013By Riëtte van Laack & Wes Siegner –
Hyman, Phelps & McNamara, P.C. has filed comments to FDA’s Draft Guidance on Frequently Asked Questions about Medical Foods – Second Edition. As discussed in a prior post, FDA’s Draft Guidance seeks to establish a policy with respect to medical foods that would eliminate medical foods as an FDA category for all but a very few products that, in FDA’s view, meet FDA’s criteria. FDA’s attempt to limit medical foods to those products that meet “distinctive nutritional requirements” of a disease or condition that cannot be met by modification of the “normal diet,” combined with FDA’s inclusion of dietary supplements as part of the “normal diet,” is contrary to important public health interests as well as the First and Fifth Amendments to the United States Constitution. It appears that FDA’s overreaching has finally united the medical food industry in opposition to agency policy, boding well for the future of medical foods and patient health.
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- OMB Completes its Review of the Final LDT Rule—A Final Rule Coming Anytime Now April 25, 2024
- Senators to DEA: Consider Treaty Obligations In Marijuana Rescheduling April 23, 2024
- “Heigh-ho” Taiho! The PTO Says LYTGOBI Patent is Ineligible for PTE Because of Untimely Application . . . And a Corrected NDA Approval Letter is No Saving Grace April 22, 2024
- Clear that Cabinet Tour ‘24 April 18, 2024
- The Fourth Circuit Upholds CMS’ Definition of “Line-Extension Drug” and “New Formulation” April 17, 2024
- Big Molecule Watch Blog
- Bloomberg BNA Health Care Blog
- Drug and Device Law Blog
- Eye on FDA
- FDA Matters
- Harvard Law Bill of Health
- IN VIVO Blog
- Internet Drug News.com
- Lachman Consultants Blog
- Medical Devices Today
- Orange Book Blog
- The Orange Book Insights Blog
- Pharma IQ
- Pharmalot
- SCOTUS Blog
- The Volokh Conspiracy
- WLF Legal Pulse
- Advertising and Promotion (Federal Trade Commission)
- Advertising and Promotion (OPDP)
- Animal Drugs and Feeds
- Biosimilars
- Cannabis
- cGMP Compliance
- Consumer Product Safety Commission
- Controlled Substances
- Cosmetics
- COVID19
- Current Affairs
- Dietary Supplements
- Drug Development
- Drug Enforcement Administration
- Enforcement
- FDA News
- Foods
- Foods and Dietary Supplements
- Fraud and Abuse
- Government Pricing
- Hatch-Waxman
- Health Care
- Health Privacy
- Import/Export
- In Vitro Diagnostic Devices
- Jobs
- Medical Devices
- Miscellaneous
- Orphan Drugs
- OTC Drugs and Cosmetics
- Prescription Drugs and Biologics
- Product Jurisdiction and Combination Products
- Reimbursement
- Tissue Products
- Tobacco
- Uncategorized