Vitamin Lawyer Update Memo: April 15, 2008
This issue:
1. FDA Food Labeling Guide
2. FDA – FTC Health Claims Crackdown
3. Allowed Product Claims
4. Are Your SOPs in Order? AER SOP Available
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1. New FDA Food Labeling Guide issued April 3rd
Says FDA regarding its new food labeling guide, “The most frequently raised questions have been addressed using a ‘question and answer’ format. We believe the vast majority of food labeling questions are answered.” I’ve looked it over and find it cogent. www .cfsan.fda .gov/~dms/2lg-toc .html
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2. FDA – FTC Health Claims Crackdown
www .nutraingredients-usa .com/news/
Good advise from a “Beltway” industry lawyer, from NutraIngredients .com -
“Just because others do it, doesn't mean it's OK… FDA regulates product labels, whereas FTC regulates product marketing. However, both agencies have limited resources… they cannot stay on top of every new product launch…. Nevertheless - budgets allowing - the agencies will clamp down when misleading health claim use is brought to their attention. When this happens, companies are held responsible for their marketing, regardless of competitor activity…
“FDA and FTC both use science as a golden standard, and this is what any safety claims for a product or ingredient need to be based on…
“If a manufacturer highlights the fact that a product contains a particular ingredient, this is considered to be an implied claim that the ingredient will have some effect…
“Keep apprised of FDA/FTC enforcement actions… "Especially in some of the grayer areas, knowing the opinions expressed by the agencies in the context of enforcement actions will give you valuable information that you can use when deciding whether to launch a new product or tweak an existing one."
“…FDA and FTC have both stressed that they are particularly wary of 'miracle cures' or 'all-in-one' cures… High on the agencies' radars are claims to cure serious diseases, products targeting children, and weight loss. They also look out for 'patches', as dietary supplements cannot be topical - they must be ingested…
“Double Blind Placebo Controlled studies with Statistically Significant Results are key to substantiating claims… However, despite the need for caution, companies should not be scared to make claims that can be substantiated… Animal studies can be important for support, but they cannot stand alone as sufficient evidence to support the efficacy of a product. Human clinical studies are what hold the real weight, and any support from animal studies is an added benefit.
“Keep your customers happy… Customer complaints can also serve to alert regulatory agencies to the need for action. In addition, companies should be sure to keep their promises…if products make money back guarantees, then companies should be prepared to honor the promise...
“‘Getting the advice of a qualified lawyer or consultant before launching a product or an advertising campaign may not be cheap, but it can be money well spent, and end up saving you a lot in the long run.’”
Ivan Wasserman, Esq. who specializes on advertising and labeling issues in the food and dietary supplement sectors, was addressing industry members at Expo West in Anaheim, California this March.
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3. Allowed Product Claims
www .nutraingredients-usa .com/news/
Please note: a “health claim” as discussed below is one step up from the typical “structure and function” claim most marketers make. S&F claims can be made without prior FDA approval, not so with health claims. Here is what
“As defined by [FDA] health claims describe a relationship between a food, food component, or dietary supplement ingredient, and reducing risk of a disease or health-related condition.
“The use - and regulation - of health claims on products varies depending on which category these fall under: medical, or non-medical. The golden rule to using claims on foods, beverages and dietary supplements is to steer clear of implying in any way that these can prevent or treat a health condition, as they would then be classified as drugs.
Foods and supplements can carry two major types of health claims: Authorized health claims or qualified health claims… Examples of [authorized] claims would include:
* Calcium and the risk of osteoporosis
* Plant sterol/stanol esters and the risk of coronary heart disease
* Folic acid and the risk of neural tube defects
Authorized health claims can also be based on an authoritative statement from a scientific body of the US government or National Academy of Sciences… Examples include:
* Whole grain foods and risk of heart disease and certain cancers
* Potassium and the risk of high blood pressure and stroke…
Qualified health claims are those based on emerging evidence for the relationship between a food or supplement and a reduced risk of disease… this type of claim must include qualifying language to indicate that the evidence supporting the claim is limited… Examples include:
* Selenium and risk of certain cancers
* Walnuts and risk of coronary heart disease…
[Other types of claims include:] Structure/function claims on foods focus on the effects derived from the nutritive value of a food… Nutrient content claims characterize the level of a nutrient in the food, either directly or by implication.”
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4. Are your Papers in order? AER SOPs
The Vitamin Lawyer .com Consultancy retainer clients have received updated versions of Standard Operating Procedures detailing procedures for Adverse Event Reporting (AER) and other changes.
If you would like a copy of the AER SOP, just send me an email with AER in the subject line and I’ll send you a copy… with my compliments.
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It’s been several weeks since my last VL Update Memo… we’ve been very busy, but I do expect to get back to one update every ten days or so. Thank you for your patience.
Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com
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