1. What are some of the regulatory issues with biotech foods? 2. Is there any reason to worry about the safety of these products?

1. What are some of the regulatory issues with biotech foods?

2. Is there any reason to worry about the safety of these products? Explain your response

3. Most food additives and supplements are either already regulated (i.e regulations about their use in food have already been issued), OR have been in use for so long that they are now generally recognized as safe (GRAS) and as such do not require a petition for their use in food preparation. Food additives are covered under the Food Drug and Cosmetic Act (Sections 201 and 409) and you can find the corresponding regulations in 21 CFR 170.3 and 170.30. However you can probably get most of the information you need by viewing the Q and A section in one of the sites below. When you do need to submit a petition (as would be the case for a new additive), you essentially have to provide Chemistry, manufacturing and control information similar to what you would do for an IND submission.

Post a response to the following:

 Are all food additives the same? Do we need food or supplement laws?

http://www.fda.gov/ForIndustry/ColorAdditives/GuidanceComplianceRegulatoryInformation/default.htm

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