Professional Pharmaceutical Legal Services in Los Angeles, CA
Mohajerian provides legal advice to pharmaceutical, biotechnology, and medical device companies on matters at the intersection of FDA regulation and intellectual property. Mohajerian has extensive experience in advising companies on market protection strategies and data exclusivity. The firm works with the FDA’s Center for Drug Evaluation and Research (CDER). The center evaluates new drugs before they are allowed to be sold. CDER’s evaluation provides doctors and patients the information they need to use medicines correctly. The center ensures that drugs, both brand-name and generic, work correctly and that their health benefits outweigh their known risks. Drug companies (“Applicant”) seeking to sell a drug in the US must first test it. The Applicant sends CDER the evidence from these tests to prove the drug is safe and effective for its intended use. It is best to use competent counsel to communication with the CDER. CDER’s physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company’s report, data and proposed labeling. If the review establishes that a drug’s health benefits outweigh its known risks, the drug is then approved for sale in US.
The Dietary Supplement Health and Education Act of 1994 (DSHEA) was enacted as a result of public debate concerning the importance of dietary supplements in promoting health, the need for consumers to have access to current and accurate information about supplements, and controversy over the FDA regulatory approach to dietary supplement products. While marketers are still limited to the types of claims that can be made for supplement products and are required to possess adequate substantiation, DSHEA revolutionized the marketing and sale of dietary supplement products.
Mohajerian's services would help clients in:
- Review of labeling and packaging to help ensure compliance with relevant laws
- Legal representation before the FDA, U.S. Customs Service, and U.S. Postal Service
- Legal representation to resolve issues around product recalls or product seizures
21 CFR 111.260(e) provides:
The Batch Production record must include the identity and weight or measure of each component used.
21 CFR 111.260 (j) provides:
The weight of each component needs to be identified and if this is manually identified: (i) The initials of the person responsible for weighing or measuring each component used in the batch; (ii) The initials of the person responsible for verifying the weight or measure of each component used in the batch; (iii) The initials of the person responsible for adding the component to the batch; and (iv) The initials of the person responsible for verifying the addition of components to the batch.â€
21 CFR 75(a) provides:
Before you use a component, you must:
(1)(i) Conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, unless you petition the agency under paragraph (a)(1)(ii) of this section and the agency exempts you from such testing.â€ (2) Confirm the identity of other components and determine whether other applicable component specifications established in accordance with 111.70(b) are met. To do so, you must either:(i) Conduct appropriate tests or examinations; or(ii) Rely on a certificate of analysis from the supplier of the component that you receive, provided that:â€¦â€
21 CFR 210 (d) provides:
The identity and weight or measure of each dietary ingredient that will be declared on the Supplement Facts label and the identity of each ingredient that will be declared on the ingredients list of the dietary supplement;
The Supplement Facts label lists the ingredients, but it does not provide the weight of each dietary ingredient, in violation of 21 CFR 111.210 (d).
The Nutrition Labeling and Education Act of 1990 (NLEA) amended Food, Drug & Cosmetic Act, requiring food and dietary supplements to have nutrition labeling.
Dietary Supplement Health and Education Act (DSHEA) of 1994, defined Dietary Supplement and added specific labeling requirements for dietary supplements.
In 1997, several key regulations for statement of identity, nutrition labeling, ingredient labeling, nutrition content and health claims for dietary supplements were implemented.
Second, the 1997 Food and Drug Administration Modernization Act authorizes health claims based on an authoritative statement of a scientific body of the U.S. government with official responsibility for public health protection or research directly related to human nutrition, or the National Academy of Sciences. Such claims may be used after submission of a health claim notification to FDA.
Under the law, claims that are allowed to be used on food and dietary supplement labels fall into three categories: nutrient content claims, health claims and structure/function claims. Disease-related claims are generally not permitted for dietary supplements.