Food and drug law in biotechnology

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 Act) defines a cosmetic as a product that is "intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance" while a drug is "intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "intended to affect the structure or any function of the body of man or other animals" (Is it, 2002, FDA). Cosmetics thus alter the appearance of the individual and are aesthetic or hygienic in nature, while drugs promote health through wellness and disease prevention, and fundamentally change the nature of a human or animal's body.

However, a product can function as both a cosmetic and a drug. For example, anti-dandruff shampoos contain a chemical with medicinal purposes that treat a medical condition. Toothpastes can whiten a consumer's smile but also contain fluoride, a chemical that promotes good oral hygiene (Is it, 2002, FDA). The purpose of the product -- whether drug, cosmetic, or both -- is conveyed through explicit product labeling and also the implications of the product's advertising.

Q4. Overall, there are structural similarities between the drug approval process for human and animal drugs. However, there is an important difference, particularly with respect to drugs for use in food-producing animals, resulting in differences in policy and approach to the drug approval process for animal drugs. What is that difference, and briefly how does it result in differences in the drug approval process between human and animal drugs?