SUPPLEMENT LAWYER J. CLARK BAIRD KNOWS SPORTS & DIETARY SUPPLEMENT MANUFACTURING
The world of Sport & Dietary Supplement manufacturing is extremely perilous: FDA regulations, DHSEA compliance, and state manufacturing laws can all be confusing. Numerous pitfalls can wreak havoc on a supplement company, turning a million dollar product into a million dollar liability. That is where the legal guidance of J. Clark Baird comes in.
Want to know how to maintain the confidentiality of your proprietary blend of Sport Supplements?
Need to find out if your pro-hormone is legal?
Insure that your manufacturing process complies with all state and federal regulations?
Want to make sure your online agents and reps don’t slander a rival company, and guarantee that you are not liable if they do?
J. Clark Baird is a licensed attorney with extensive experience in both civil litigation and criminal defense. Mr. Baird knows how to navigate the confusing world of state and federal agencies, including: the FDA, the DEA, the US Attorney General’s Office, state attorney general’s offices, the US Marshall Service, and the US Postal Service. Whether you are start-up supplement company trying to obtain GMP manufacturing certification or a major vitamin manufacturer dealing with an FDA hearing, J. Clark Baird has the legal expertise necessary to resolve your issues. Whether you have litigation in state or federal court, J. Clark Baird is available across the nation to help your supplement company.
Clark is a long-time supplement junkie, who has combined his legal expertise with his love of nutritional supplements. Whether it is CLA, l-arginine, DHEA or creatine, Clark uses an extensive array of supplements and keeps himself on the cutting edge of research. He has maintained an active internet presence on all of the major supplement-based and bodybuilding websites, insuring that he is always at the forefront of developing trends within the industry. J. Clark Baird combines professional excellence with a personal passion to insure that your company and its products are our first priority.
Dietary supplements, also known as health supplements, can include vitamins, minerals and more. The Dietary Supplement Health and Education Act (1994) defines a dietary supplement as a product that, when ingested, is meant to supplement your diet. The product must be labelled a “dietary supplement” and cannot be marketed as food to be consumed as a complete meal. It must be intended for consumption by mouth in the form of a pill, capsule, liquid or powder, and it must contain one or more dietary ingredients such as a vitamin, herb, mineral, amino acid, etc.
The Dietary Health Safety and Education Act of 1994 (“DSHEA”) amends the federal Food, Drug & Cosmetic Act (“FDCA”), the foundational federal law governing foods, drugs, cosmetics, and medical devices.
Definition of Dietary Supplement
The DSHEA specifically defines a “dietary supplement” as:
- a product taken by mouth
- that is “intended to supplement the diet”
- and that contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance used to supplement the diet by increasing total dietary intake; or, a concentrate, metabolite, constituent, extract, or combination of any ingredient intended above;
- further, the product must be labeled as a dietary supplement, and,
- must not be represented for use as a conventional food or as the sole item of a meal or the diet. (Note: this part of the definition does not mean that we are only talking about weight loss or dietary products.) The key regulatory impact of the DSHEA is that a product that meets the definition of a “dietary supplement” does not need FDA approval of safety and effectiveness before being marketed.
We guide clients who have products that are more properly regulated as beverages (foods). Lines can blur — for example, consider a bottled water drink containing vitamins. We also counsel regarding regulation of a product as a food additive.
Regulation of Claims and Labeling
Once we know that product will be regulated as a “dietary supplement,” we generally focus on two sets of legal rules relevant to marketing: (1) rules governing claims that can be made regarding the product, and (2) rules governing labeling for the product.
Claims come in four basic varieties:
- structure/function claims
- disease claims
- health claims and qualified health claims
- nutrient content claims.
Basically, dietary supplements cannot make “disease” claims (for example: “this supplement shrinks tumors”). Dietary supplements that make disease claims will be regulated by the FDA as drugs.
Dietary supplements can make “structure/function” claims (for example, “calcium builds strong bones”). A structure/function claim describes the product’s role in maintaining the “structure or function of the body,” or “general well-being.”
Labeling rules are detailed. Depending on the ingredients, different rules come into play. For example, one of these rules provides that the “principal display panel”—the main panel for the supplement—must provide a “statement of identity” for the product.
The Federal Trade Commission (“FTC”) has overlapping jurisdiction with the federal Food and Drug Administration (“FDA”), and focuses more on whether advertising is truthful, or false and misleading. Thus, it is important to respect nuanced labeling rules, including those regarding the statement of the identity
The main problem with dietary supplements is that the manufacturer determines what mixtures of supplements can be used, how much of each supplement is added and what is an acceptable, safe amount for consumers. Some products can contain a combination of ingredients that differ from the original supplement. Inadequate labeling and false advertising is another major issue.
Innovative new companies on the sports supplement scene are choosing J. Clark Baird for their legal counsel. Trailblazers in the supplement industry have insured their companies’ futures by retaining J. Clark Baird. Whether you produce pro-steroids, energy drinks, bulk powders, multi-vitamins, or complex proprietary blends, J. Clark Baird can assist you. Don’t let your company “fly blind” any longer: protect your company and your products!!!!
Our Supplement Law services include:
- Advising on the classification of products as dietary supplements
- Advising on all aspects of labeling and advertising in compliance with FDA and FTC requirements
- Counseling on compliance issues relating to good manufacturing practices, record keeping, product recalls, market withdrawals and FDA inspections
- Developing permitted product claims with respect to structure/function and disease claims
- Filing 403(r)(6) Notifications to the FDA for Statements of Nutritional Support
- Providing New Dietary Ingredient (NDI) and Old Dietary Ingredient (ODI) opinions
- Preparing and Filing New Dietary Ingredient Notifications
- Developing and implementing key marketing strategies such as “Third Party Literature” (under section 5 of DSHEA), that may be used to substantiate disease/drug claims
- Providing guidance on safety testing of dietary supplements including toxicology, carcinogenic and sample testing
- Defending against FDA and FTC enforcement actions
We can review or prepare labels and advise your company regarding products requiring FDA/FTC-compliant labeling such as dietary supplements, nutraceuticals, or cosmetics. We will assist with FDA compliance regarding foods, dietary supplements, drugs, or medical devices. We can determine whether product names and claims cause the product to meet the FDCA definition of “drugs” by making implied disease claims (versus allowed structure/function claims). We can review client’s evidence of substantiation of claims in light of federal and state substantiation requirements, and draft compliant disclaimers. In addition, we can provide legal review & advice relating to Marketing Materials (including brochures and main website) in light of FDA and FTC issues concerning claims, testimonials & endorsements.
DO NOT SPEAK TO LAW ENFORCEMENT AGENTS OR RESPOND TO A CEASE AND DESIST LETTER OR REGULATORY COMPLAINT WITHOUT AN ATTORNEY. CONTACT SUPPLEMENT LAWYER J. CLARK BAIRD IMMEDIATELY IF YOU HAVE A LEGAL ISSUE OR NEED LEGAL REPRESENTATION. (502) 583-3388 [email protected] or REACH US 24/7 at (502) 797-4625!! PROTECT YOUR COMPANY AND YOUR RIGHTS TODAY!