Research Paper: Food and Drug Law in Biotechnology

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Food and Drug Law in Biotechnology: Questions

Would the enactment of the DSHEA have changed the outcome in Nutrilab Inc. v. Schweiker, 713 F.2d 335 (1983)? Assume the manufacturer promoted the product as helping to maintain a healthy weight.

In the 1983 case of Nutrilab Inc. v. Schweiker, 713 F.2d 335 (1983), the case involved so-called 'starch blockers' that were supposed to inhibit the body's digestion of starch and thus facilitate weigh loss. The manufactures of the product called the item a foodstuff, given that its ingredients, some of which were natural (such as fibrous beans) were consumed as food in some contexts. Nutrilab's case failed upon appeal. The "FDA had received seventy-five reports of adverse effects on people who had taken starch blockers, including complaints of gastro-intestinal distress such as bloating, nausea, abdominal pain, constipation and vomiting. Because plaintiffs consider starch blockers to be food, no testing was required to obtain FDA approval as a new drug has taken place" (Nutrilab, 1983, Altlaw).

Thus, the issue at hand was the classification of the substance as a food or a drug, not product claims about weight maintenance. Had the drug met FDA approval after a scientific study was conducted and showed that the pill did produce weight loss and was safe, such a claim would be allowed. The Dietary Supplement Health and Education Act of 1994 (DSHEA) involved products labeled as 'supplements' and the starch blocker was not labeled as a supplement.

Q1b. Assume the manufacturer promoted the product as a treatment for obesity.

Once again, the issue is not just the validity of the claim, but the claim of the FDA that the starch blocker was a drug, versus the manufacturer's claim that it was a food: for a drug to be prescribed as a treatment, even an over-the-counter drug, the drug must be approved for such use by the FDA. Even if the company had claimed that the starch blocker was a supplement, and neither a drug or a food, "under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer was responsible for ensuring that a dietary supplement is safe before it is marketed" (Dietary supplements, 2010, DSHEA). Supplement manufacturers must ensure the product is safe (which Nutrilab did not) and also that the advertisement for the product is truthful (which it was, tenuously, but only because the product caused such severe dietary distress, weight loss was the result).

Q2. What is a predicate device? Discuss its role in the FDA device approval process.

A legally marketed 'predicative' device is one "to which equivalence is drawn" between a new product and a product already on the market (How to find a predicative device, 2009, FDA). A claim of substantial equivalence "does not mean the device(s) must be identical. Substantial equivalence is established with respect to: intended use, design, energy used or delivered, materials, performance, safety, effectiveness, labeling, biocompatibility, standards, and other applicable characteristics" (How to find a predicative device, 2009, FDA). A premarketing submission can be made to FDA and use existing products to demonstrate that the new device to be marketed is safe and effective.

Q3. Under the FD&C Act, what is the difference between a cosmetic and drug? How can a product be both?

The Federal Food, Drug, and Cosmetic Act (FD&C… [END OF PREVIEW]

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Food and Drug Law in Biotechnology.  (2010, April 22).  Retrieved May 21, 2019, from https://www.essaytown.com/subjects/paper/food-drug-law-biotechnology/95711

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"Food and Drug Law in Biotechnology."  Essaytown.com.  April 22, 2010.  Accessed May 21, 2019.
https://www.essaytown.com/subjects/paper/food-drug-law-biotechnology/95711.